MICHAEL SMITH : Welcome to this presentation on Eroxon. It's my absolute privilege to be here chairing this meeting about a new treatment for erectile dysfunction. And it's my even bigger privilege to be surrounded by some of the key opinion leaders around this treatment. Hopefully you'll find this very informative. Before I go through the day and how we're going to conduct it and the way of asking questions, I think I'm going to introduce our faculty, starting with myself. My name's Dr. Michael Smith. I am a GP, a general practitioner from the United Kingdom. I also am involved in many integrated care systems as a strategic advisor. I also have a big background in terms of new and innovative treatments in the National Health Service. And I chair a lot of meetings like this. I'm going to hand over to Professor Ralph to introduce himself.
DAVID RALPH : Thank you, Mike. I'm Professor David Ralph, based at University College Hospital London, and I'm a Urologist, but my main field of expertise is in Andrology, so male sexual dysfunction any abnormalities of the genitalia. You can see that I've chaired many of the societies currently chairing the European Society of Genitor Urethral Surgery and also the president of the Sexual Advice Association, previously known as the Impotence Association.
GERALD BROCK : Hi, my name is Gerald Brock. I'm a Urologist from Canada and like David, I've been involved in the field of sexual health and sexual medicine now for three decades. One of the things that I've been involved with early on are medical therapiesfor sexual dysfunction. We call them the PDE5 inhibitor drugs. Drugs like Viagra, Cialis, Levitra. And so I'm really excited to be part of this webinar. I'm the current president of the International Society for Sexual Medicine, which is the world's largest group of healthcare professionals devoted exclusively to sexual health. So I'm really excited to be part of this programme today.
ANNAMARIA GIRALDI : Hi, my name is Annamaria Giraldi and I'm also so excited to be here together with good colleagues and the audience. I'm a psychiatrist and I work in the mental health centre in Copenhagen, where I also have a professorship in clinical sexology. So I deal with both young and older men with erectile dysfunction. And I'm doing both pharmacological treatment, but also the most psychotherapeutic treatment. And I also sometimes treat the couples and women with low desire and I'm the past President of International Society for Sexual Medicine.
MICHAEL SMITH : Thank you very much everyone ! I think you all agree that's a very distinguished faculty there. So the way that we are going to conduct the day over the next hour, as you can see, we're way into the agenda already. As I introduce you to the faculty in a short while, we're going to see a short presentation pre-recorded by Professor Ralph and afterwards we're going to get probably to the mea of things with a question and answer session. Now this starts off wit questions that have been submitted in advanced by the audience and we had a look at them, answers already to them, but then I think comes to the quite interesting bit when you are putting us on the spot and asking questions during the presentation. Without further ado, I'm going to now ask them to present the clinical background of Eroxon with that pre-recorded presentation.
DAVID RALPH : Thank you Michael. I just want to spend 20 minutes or so going through the clinical data and how we got to where we are now in the management of erectile dysfunction using Eroxon. Just to say that... I mean we are talking about a big problem here. Erectile dysfunction currently has 152 million men, in the world and you know that's going to increase by 2025 to 322 million and ever increasing as patients demand treatment. We started way back in the sixties with primitive treatments and as you can see from this flow chart that going from just penile implants and then into cavernosal injections, the discovery of PDE5 inhibitors in 1998 revolutionised it. And so, you know, as you get better treatment, patients demand more, the expectation of, you can just treat anything and have a normal expectation of sexual life occurs. And so we need future treatments and hopefully I'm going to show you one today. I think the PDE5 inhibitors, as I said, was a real breakthrough. Patients will come forward now for treatment more readily, but there are some limitations as described on this slide. Yeah, I mean there's a delay. I mean, you take a tablet, you have to wait 60 minutes or so. And so patients often say that, you know, I don't really have any spontaneity. I don't like the idea of having planned sexual activity. Sometimes you can't take it because they're on contraindicated medications such as nitrates. And in the younger group we've seen sort of the misuse of these pills in the clubs. Patients come in with priapism, for example, after they're taking the PDE5 inhibitor, cocaïne and lots of alcohol. It also should be said that it's not just with PDE5 inhibitors, many treatments really that, you know, you start the treatment and then 50% of the patients aren't using it after one year either because of the side effects or the various aspects to the medication. Lack of spontaneity and in intimacy as I said. And so it is important to treat erectile dysfunction because certainly in the male you've got to reduce quality of life.Also, of course it impacts on the partner. We mustn't forget the partner. I mean they're key in this not only in all the diagnostic aspects, but in the treatment involve the partner, it includes them as well. They have lack of self-esteem and clinical depression. I've seen some that are really are depressed and it affects not only the relationship but also in the workplace as well. So you can see this sort of catch 22 situation that if you have a treatment that is efficacious, then not only do you then have that works rapidly, then now you've got that spontaneity, you have the intimacy and then it sort of goes round in a circle and basically to get back to normal again. So it is important to treat. So what is Eroxon? Here, it's a gel that you apply to the gland's penis. It's been clinically proven and I'll go through the data with you to be effective in all aspects of erectile dysfunction, mild to severe. It's applied topically and the most important thing, it works fast. 60% get good response to erectile activity at 10 minutes. Good thing of course is that also, you know, you can be discreet but also the partner can get involved by applying it to the gland's penis. And in a fair number of partners did that in the clinical trials. So the whole tube is used, so it's a one tube, it's just one treatment episode. You put it onto the finger and rub it onto the gland's penis for about 15 seconds or so. And it can be used clearly as part of foreplay as well. How does it work? Well, it works by a temperature effect because of the alcohol, the ethanol within the product, then you get a cooling effect up to 10 degrees on the glands and then a gradual warming. And this is thought to be the mechanism of the neuro transmission. And clearly when you have an erection, then the neurotransmitter is nitric oxide and more studies basic science is going to be needed to prove that this is actually the way it works. But this is the way we suspect it works. But it works pretty quickly. Let me go through the clinical data on two trials that we've had. So one was conducted with in Europe to gain the CE mark and the UKCA mark. And then to get FDA approval in the states,then a second study was done both in the USA and in Eastern Europe. Now this is the first study, the FM57 study. And actually this was studied looking at GTN cream or glyceryl trinitrate cream at various concentrations applied to the gland's penis as a topical therapy. The Eroxon was actually the control arm and in large it gave good results with minimal side effects. And we thought actually this was probably better than the GTN that was used. You now obviously if you have GTN, you can get absorption of GTN and headaches et cetera particularly with the higher doses. And so this seemed to be ideal as a treatment for erectile dysfunction has similar efficacy but less side effect profile. This is the results of that study. And when we use these studies we have questionnaires, some of you will know
the IIF questionnaire, the international erectile function questionnaire, which is a series of questions that you ask over the last four weeks. How have your erections been for example and different aspects of that. And if there is a four point change in the results when you use a product, then that's clinically significant. In other words, the patients will realise that there is an effect from the medication. And you can see that change, well in this study the average was 5.1, remember four is what's considered clinically significant and the overall response rate was 63%. And across the board, whether it be mild, moderate or severe. The diary questionnaires, which is called the Sexual Encounter Profile, two and three is,were you able to actually penetrate? And if you were, was it able to last long enough to have sexual activity? You can see the response was 75 and 68% respectively, again across all the mild, moderate and severe aspects. Now, just as if you're using a PDE5 inhibior or any treatment for erectile dysfunction, it takes time to learn how to use it. And these patients were given six trials within that four week period as you can see here. And you had activity so that the sixth one had a better response than say the first one. And what's important from here is that it was not just at the first four weeks that response was maintained up to the eight weeks, both the SEP 2 and the completion of sexual intercourse the SEP 3 questionnaires, time of onset, you can see 60% achieved erection within 10 minutes, 75% within 20 minutes. And even at five minutes a third of the patients were starting to get good quality erections. So remember this can be all part of foreplay anyway. So one would expect you to have five to 10 minutes of foreplay. So it seems to be quite ideal timing to have spontaneous sexual experience. As you would expect from a product that really is not a drug and indeed the licence is for a device. This side effect profile is pretty favourable, 3% headache risk. And a couple of patients had some penile burning and one female had some vaginal burning. So fairly well tolerated and extremely safe. Now the second study is to get FDA approval. So this was performed both in Europe and in the US using USA patients. And it was a 24 week study as opposed to a 12 week study.'Cause this is what the FDA wanted. And we were comparing Eroxon with on demand five milligrammes of tadalafil and that's what is licenced in the USA, the five milligramme dose.
Same sort of questionnaires and follow up, and as I said, the primary endpoints here was the change in the IIEF erectile function domain score at 24 weeks. And remember we talked about the minimal clinical important difference. The MCID should be at least four points to have any clinical meaning. And you can see that that was more than that, certainly the end at six months was 5.73. And so you can see that the efficacy, if anything, improves as you saw on the previous study because they have a learned way of using the product. This will just give you the results. You can see 61% of the Eroxon exceeded that four point improvement. It was better in the tadalafil five milligrammes on demand at seven, at 87% throughout the four to the 24 weeks. But both are pretty effective. The Eroxon of course been with less adverse events as you can see on this slide. So the tadalafil patients, this is a typical PDE5 inhibitor adverse event profile with headache and back pain. And sometimes that's the cause that patients discontinue medication. But with the Eroxon, a few, two patients with a headache and two who are a little bit nauseous. So from the Eroxon was achieved a highly favourable side effect profile compared to tadalafil, no local side effects in any of the females either. And of course when you're using this on topically, then you're not going to get that adverse drug interactions that you might get such as nitrates with PDE5 inhibitors. So time to onset again
in this particular study, 63% responded within 10 minutes. You wouldn't expect tadalafil to work within 10 minutes. In fact, as you know, you have to wait for longer than that up to an hour. So we wouldn't expect that figure for the tadalafil group. So these were the two studies we've just discussed and their similar results, different patients groups, different length of duration. The meaningful clinical response was the same in both groups and you can see the response rate 63% in both. So you'd expect two-thirds of these patients to respond within 10 minutes using a local application of this gel. This might be a little, little confusing slide, but you can see the dotted red line is that four points. The four points, the MCID level, that means it's clinically significant and we put the yellow start of Eroxon mixed in with all the other studies of sildenafil, tadalafil and vardenafil. And you can see all of them compared to the blue dots of placebo over above that line in both studies. So just as a summary then, it's clinically proven it's effective in mild, moderate and severe erectile dysfunction. It's a topical application which clears what patients would prefer if they were given the choice because there's no drug interactions, it's fast onset of action will enable spontaneity, which patients want to have and of importance of course it is important that the partner is involved in treatment and indeed a third of all applications were done by the partner in foreplay. When is it going to become available? Well, it's got a CE mark in the EU and CA mark in the UK. So certainly it's available in Belgium now, the rest of Europe later on this year. So this is exciting, it's a new product that we have. It's been a long time since we've had a new product for erectile dysfunction. It's available over the counter, so it's discreet. And the spontaneity because of the speed of action is what is really exciting because this is really what patients want. Thank you very much.
MICHAEL SMITH : Thank you very much there. I think what we're going to do now is go straight into our question and answer session. Professor Brock, does 10 minutes really matter?
GERALD BROCK : You know, I think timing is absolutely a critical aspect of any treatment for sexual dysfunction. Guys typically want exactly the same series of characteristics. They want it to be natural, they want it to be fast, they want it to be effective and they want it to be free of side effects. But the timing part is the most common reason why pills like Viagra and Cialis fail. Guys take a pill and they want to have sex within five or 10 minutes. And we know, as David alluded to that drugs like Cialis don't actually reach their maximum concentration until two hours after you ingest it. Drugs like sildenafil, Viagra about 60 minutes. So the idea that you could actually have two thirds of the patients responding within 10 minutes is really an important difference.
MICHAEL SMITH : So what happens if they try in say five minutes?
GERALD BROCK : Well, David probably can address this better than I can, but the data says that about a third of patients will still succeed. And you know, the beauty is that as physicians we can inform our patients how best to take this medication. And with the literature that'll accompany the product, they'll understand that if they don't succeed at five minutes, they can continue with the sexual repertoire, continue with stimulation,and it looks like another third will then be successful over the course of the subsequent five minutes.
MICHAEL SMITH : Professor Ralph, did you want to come in there and have an opinion on what happens if they tried five minutes.
DAVID RALPH : Well, I think certainly from the clinical trials it was about a third of patients responded at five minutes and almost three quarter 75% if you waited for 20 minutes. So obviously there's a range, but you would expect this to work quickly anyway with the alcohol effect and the drying and the change in temperature. I mean that happens pretty quickly. And so they're being stimulated, you know right from the start. And you know, some are responding well at five minutes and majority at 10 minutes. It's where you pitch it really, isn't it.
MICHAEL SMITH : And you mentioned the minimal clinically important differences, the MCID let's call it MCID too short, I'm not going to say that every time. What does it actually mean in practise and why is that important?
DAVID RALPH : I mean, we judge efficacy of all of these medications. I mean the PDE5 inhibitor and any drug trial that we do on questionnaires. And this is just one questionnaire that's been used now for sort of 15, 20 years and has been validated. And so you get your questions and you'll get your various points per question and you know,you may say, oh you've got an improvement because you had a better score. But you have to have further patience to actually say, "Well actually I think I did have a... you know, there was a clinical significant difference, which I appreciated." It has to be a four point score. So that's the minimum, below that yes, you may say, well look, it's beneficial, but the patients aren't going to recognise that.
MICHAEL SMITH : Thank you very much Professor Giraldi can I ask you, based on your own clinical experience, why is it so important to involve the partner when you're treating erectile dysfunction?
ANNAMARIA GIRALDI : I think it's quite obvious because most of the time sick to something happens between two people and if you involve the partner, it's going to be better. I think that the partner's going to be more satisfied, the man is going to be more satisfied, there's an interaction. And I think when we talk about the timing as you addressed before, just the fact that you can see and effect pretty fast is the partners also getting aroused by that. Because very often people, when they have sexual interaction, a very important thing is that you actually se that the partners aroused. And if you can include it in your foreplay as you can now, instead of like waiting for now something is going to happen,now we can start, it's a more natural interaction, and you'll actually see a response. And I think that's so important for the partner too. So I think that's one of the good things and just the fact that as we heard from the data that David Ralph showed that actually the partner was the one applying many times the gel, that's important too because it's not like the man will go out and take a pill and come back and say, "Now I took it," but instead you do something together and have interaction and the dynamic, which is so important.
MICHAEL SMITH : Did anyone else would comment on Professor Brock, Professor Ralph, what's your experience in partner involvement in the treatment of ED?
GERALD BROCK : Yeah, if I could Michael, I agree with Annamaria. I think the partners are critical and the idea that this is a therapy where the partner can be intimately involved, it's different when you're applying something onto the penis as opposed to taking a pill. So I think that's an advantage of a topical agent. But if I could just go back a second, Michael, Just to the MCID. You know, I agree with what David said, absolutely, but to me the importance of the minimal clinically important difference is that we see lots of studies out there that show statistical significance and that's because you have lots of patients in the study. And so even a sall difference can be statistically significant, but as clinicians we want to know, is this drug going to be recognised by the patient as being an important difference? And the data would say that if it's above four points on most patients, and it's slightly different, if you have really minimal erectile dysfunction, you need actually a smaller MCID. And if you have really bad erectile dysfunction, you need a bigger one to make a difference. The patient recognises but the bottom line for clinicians is the studies that were done on Eroxon show that patients notice the difference and ultimately that's why we prescribe something or why patients go to the pharmacy and pick up something because they can notice an improvement in their function.
MICHAEL SMITH : Brilliant. Professor Giraldi I'd like to go back to you for a moment. Just from what you've heard about this, this treatment and from your experience. Why do you think couples, apart from the obvious partner involvement, are there any other reasons that couples might prepare Eroxon over sort of some of the tablet treatments such as Viagra or the like?
ANNAMARIA GIRALDI : I think it's a very important question. I think one of the things that I hear very often in my clinic is that the partner says, "Oh, you just take a pill. So it has nothing to do with me." And I think this is a little bit different because it's involved maybe in the foreplay. It's not that you take a pill. So I think the perception of it is also going to be different because it's not going to be okay, it could be anyone. No, it, it's something that happens with the couple. They use it, and I think very often the partner will say, "It hasn't to do any..." they don't like that the man make me take a pill because they say he can take a pill and then it has nothing to do with me. So I think that's one of the important things by this product.
MICHAEL SMITH : So I want to sort of open this up to the whole faculty really this next question. So just looking at your presentation there, Professor Ralph,it seems that a Eroxon was attended as a placebo to begin with and it was sort of found serendipitously, I think was the word youused to be effective. What's your view on the Eroxon in terms of actually any placebo effect that people might be getting? I mean that's to the whole panel.
DAVID RALPH : Yeah, well, I mean, with any treatment for erectile dysfunction, there's going to be a placebo effect, and I'm sure Eroxon is no different. But it's a topical agent, obviously it works. I mean and I think to some extent when you discover things by accident, oh thisnis totally unexpected, well hang on a second. It harks back to 1998, doesn't it? Or just before in the PDE5trials where suddenly,you're switching it from a cardiac drug to treating erectile dysfunction. So it was discovered by accident. And just on your last question there, Michael, about the partner. I think the partner needs to be involved because,there's less guilt worry, and of course therefore better sexual performance because if they have the worry and anxiety that their partner might find out, then they're not going to perform as well. I think if the partner's,you know, in on it, even applying the gel and it's a sort of a more relaxed environment, you're going to get a better response.
ANNAMARIA GIRALDI : And I think some of the placebo effect is the more relaxation and you can, you know, this is something that's going to help you. And as David says, we always have a very high placebo effect in any trials tha looks at erectile dysfunction.
GERALD BROCK : You know, Michael, I would take exception to how you're characterising it to be honest, because I don't think it's the placebo arm that we're actually looking at. We were looking at the control arm and I think that's an important difference. Serendipity has played an important part of medical advances for hundreds of years from penicillin to other aspects of agents that we currently use commonly today. And you know what we think, and as David talked about in his presentation, really quite well, it has to be proven, but we know very clearly that the concept of reactive hyperemia, meaning that if you occlude a blood vessel, either you cause vasso constriction or external compression and you release that obstruction, you get a rapid flow of reactive blood flow through that vessel that causes release of nitric oxide because the vasculature are stretched. And so the whole theory is exactly this with Eroxon that what you're doing is causing constriction and then reactive hyperemia increased blood flow in combination with stimulation. And so I think it isn't fair to call it a placebo, but really it was the control arm of the studies.
MICHAEL SMITH : Point taken. So I want to get to the practicalities of it. So as I understand it, I think someone said it was like an alcohol hand gel in terms of its consistency. Can anyone tell me what does it taste like?
DAVID RALPH : Well I haven't, myself personally tasted it, but it's reliably being told it's a little bitter to taste I guess from the alcoholic base, but that's what the patient's saying.
MICHAEL SMITH : And in terms of someone mentioned getting it over the counter rather than having to get a prescription, you know how easy is it for a patient to access this treatment?
DAVID RALPH : Well, it's over the counter,nso I mean they just speak to the pharmacist when it's lodged hopefully in the UK in the next month or two. And you can get it over the counter. It's quite simple, remember it's not a drug, it is a bit of glycerine and alcohol base. So it's pretty safe and that's why it is over the counter.
ANNAMARIA GIRALDI : And I think the over the counter is also very nice for a lot of men because a lot of men feel very embarrassed to go to the physician and I think it's going to be nice that they can hear about it, they can go, they can try it and if it doesn't work then they can go... now they started the process. So I think it's really a big value of this component.
GERALD BROCK : I can tell you that within the Canadian healthcare context, and it may be different than in many European countries, that there's a huge shortage of physicians and access to physicians is really quite limited. That in addition to the fact that it's still a taboo subject in many parts of the world and going to a doctrine saying I'm having erection problems, sexual dysfunction can be an obstacle to care. And so the ability to go to the pharmacy pick it up over the counter I think is a huge plus.
MICHAEL SMITH : It's a really, really good point actually. And I suppose in terms of what the UK it's no different when it comes to access to physicians. We are relying increasingly on other members of the healthcare team perhaps with less medical training. I suppose my next question is, you know, can those people safely sign sign post people to going to the pharmacy to purchase this drug in terms of, you know, 0coexisting conditions, interactions between drugs, is this something I could get my other health healthcare professionals in my practise to do in your experience?
DAVID RALPH : Well, you know Michael, a drug only goes over the counter, usually a lower, lower, lower dose as well if it's safe, safety is the main concern. I think more importantly safety than efficacy, to be honest with you. And this is extremely safe and it doesn't really matter what drugs the patients are on 'cause there's no real interaction, so it's really safe.
ANNAMARIA GIRALDI : And I think the message it also sends, I see many men that are so afraid of taking PDE5 inhibitors still, even though we have a huge experience, we know they're not dangerous, we know they're actually, a lot of men come and say, "I can really feel I get high blood pressure," and I know no, you don't get higher blood pressure, but they think they do. So I think the fact that you get something over the counter for some men will be really nice and also for their partners because they actually know. I mean the physician can tell so many times this is actually a safe drug and I think PDE5 inhibitors are too, but it also signals that this is really a safe drug and I think that means a lot for both men and their partners.
GERALD BROCK : You know, habits are hard to break. And all of us around the panel here keep referring to this as a drug. I think it's important for the webinar for people who are listening to understand that we don't think it's really a drug. We think it's an application of an agent that causes vasodilation, but it's not a drug, it's the evaporation, of the alcohol that's probably causing that clinical and physiologic effect. And the fact that it isn't a drug means that there are no possible drug-drug interactions. And so by the very nature of the fact that there isn't an active pharmaceutical ingredient in this product means that you don't have to worry about an interaction with nitroglycerin or blood prefre pills or other medications.
MICHAEL SMITH : And I suppose that's a really interesting point because in in my practise it is largely incidentally we pick up erectile dysfunction and I'm talking about patients with diabetes, ischemic heart disease, metabolic syndrome, other conditions and I'm just trying to work out whether this, and I suppose what I'm hearing is that this sits quite safely within that pathway as patients in terms of perhaps a first line treatment where they don't want to leap straight in for a tablet because as you've said, my experience is a lot of patients have a bit of anxiety around that, a lot of patients, there's
a bit of stigma around that. And so I'm hearing from the panel largely that actually that could form part of that treatment pathway is that right?
ANNAMARIA GIRALDI : Yeah.
MICHAEL SMITH : Okay.
DAVID RALPH : And I think so Michael and... you only have to ask the audience, you know, would you rather put a topical cream on the gland's penis or would you take or would you like to take a tablet that possibly has some common side effects such as a headache?
MICHAEL SMITH : So Professor Giraldi, do you see any problem obviously the concomitant drug use of cocaine, et cetera, do you see any problem with people just using this as a way to enhance sexual intercourse that don't have ED?
ANNAMARIA GIRALDI : Yeah, I think that it's never bad that you try to enhance your sexual life and your sexual performance. I mean there are many products we know there are millions of products and I think what's I like about this is that we actually know something about it. Because when you see what people pick up on the internet, I mean sometimes it's really doesn't have to be a drug, it can be a lot of other agents and thing you put on your penis and I think you're so surprised how many things people actually try to enhance their sexual performance. So I think what I like about this one is we know it's safe, we know it has been tried in a trial, so we know what it is and we don't have any concerns about the mechanism actions. So I think that I don't see, I mean, why not try to enhance your sexual life? Of course some people would do it in a destructive way, but a lot of people it will just add something to their sexual life and to their partner's sexual life.
GERALD BROCK : Mike, it's always a question I've been interested in because it gets asked about a variety of different products and the question is how do we define sexual dysfunction? So if I am able to get and keep an erection, but I'm not satisfied with the quality of my erection, does that mean I hav erectile dysfunction or not? If I'm able to penetrate my partner regularly, and if I take an IEF as David talked about earlier, and I score in the normal range, but I still feel that my erections aren't as good as they were when I was 20, do I have erectile dysfunction or not? Now I'm not debating the fact and I agree with David that there certainly are lots of episodes and evidence of abuse of all these drugs, but to me I think that specifically a compound that doesn't have any active pharmaceutical agent in it, that will come with a product insert that will explain information about sex and sexual function and provide that individual with additional confidence and perhaps some additional function. I don't see that as a major concern for abuse.
ANNAMARIA GIRALDI : But I think it's such quite interesting question because I mean ever since we had the PDE5 inhibitors, we have discussed this and I think it's because it's about sex. Because we do so many things in our daily life where we use something,you know, nutrition,whatever it is to enhance alot of different performances,I think it's something that comes because it's about sex,so we suddenly a little afraid or are we going to use it, in the wrong way? And there will always be people that misuse whatever they can misuse, but I think the majority will not do that. So I think it's also like a little philosophical, so interesting. Why do we still discuss this? Because we all agree that healthy, good sexual life for the individuals are very, very important for our overall quality of life.
MICHAEL SMITH : So what I'm also interested in is what about if you were to use this alongside a tablet? So let's say you used a PDE5 inhibitor alongside Eroxon. Can you see any problem with that in terms of safety?
GERALD BROCK : We don't actually have the data, Mike. But the study hasn't been done. I can't imagine it, it'll be a problem because again, there's no active pharmaceutical ingredient here. So I think the risk to the patient is minimal, whether it is sort of a synergistic effect and it's a bigger combined effect than each agent individually. We don't know that yet.
MICHAEL SMITH : Thank you, so we've got some of our audience questions already starting to come across. Just whilst I'm sort of filtering through this, can I just ask our panellists just to sort of think about how they'd like to summarise as we approach the end of this webinar? Just a couple of sentences in terms of what you think people's take home messages are. Now, I'm just going to pick some of these at random. I think there is a really, really good one and someone's said that they're that erectile dysfunction is becoming more of a problem in younger people. So I suppose my questions to the panel is this, are we just picking up in more younger people and what are your thoughts on that? Perhaps because he's on the screen in front of me. Start with Professor Brock.
GERALD BROCK : Okay, well in my practise it's clearly the case. I'm not sure if that's becomes because it's become socially acceptable for young men to see physicians and ask for help if it's an internet effect where they have expectations of a certain degree of performance, whether it's covid effect, because a lot of us have not had the social interactions that we typically did in the past. But I would agree that I think there's a larger number of men who are coming forward. The other part of the piece may be the fact that I think generally we're not as healthy as we were 20 years ago. And that's true for young people. I think the obesity and morbidities that young people have is clearly greater. And that may be related to lack of physical activity and overall health, but I think that something like this where the individual can take control go to the pharmacy, their sexual capacity, I think it's a real plus.
MICHAEL SMITH : So Professor Giraldi do have an opinion on younger people presenting more with-
ANNAMARIA GIRALDI : Yeah, I think Dr. Brock said it very nicely, and I think that we see them more often now, but I also think that I would agree that we see more younger people, at least where I am, because they have more stress, they have more anxiety. At least that's what we see in Denmark. And also I think that the changes between genders that we have different roles now than we used to have maybe 30 years ago or 50 years ago, puts more pressure on men and especially on young men. And I think that's where we see some of the younger men coming seeking treatment more often than we used to, I think that also has changed. The demands for young men have changed.
MICHAEL SMITH : And finally, Dr. Professor Ralph, do you have opinion on younger people.
DAVID RALPH : Yeah, well it's not... I mean the number of patients with erectile dysfunction has increased, I think by 2025 they say should be worldwide 320 million. I mean 20 years ago it was half that. So I mean and that's just by that we have is increasing all over the world. And so the risk factors for ED are increasing and that doesn't affect just the older patients, also affects the younger.
ANNAMARIA GIRALDI : And I think that includes mental health. I think that's very important too.
DAVID RALPH : Yeah.
MICHAEL SMITH : So, one of the questions that has popped up is, obviously we've got three experts, key opinion leaders with regards to erectile dysfunction. What about those healthcar professionals who aren't, it's not primarily what they deal with. Have you got any tips about how easy it is or how one might bring up the topic of around erectile dysfunction without both the healthcare professional and the patient feeling embarrassed about it? I mean, once again, you are talking very openly and easy about it, but clearly some people are saying, it's a difficult thing to address. Any tips on that?
GERALD BROCK : What I usually, sorry, Annamaria, what I usually do is I just ask the individual, do you have any concerns about sexual function? And then if the individual's uncomfortable talking about it, they just say, "I have no concerns." Or if they have normal function, they say "No, I have no concerns." But for the individual that was wanting to talk about it, which the studies have shown roughly 80% of people with sexual dysfunction want their physician to raise the question that it gives them an opening where they can start talking about it. "So do you have any concerns?" And that's a nice easy open-ended way to introduce the conversation.
ANNAMARIA GIRALDI : And one thing you could add to that is I think it is our responsibility as healthcare providers to open the discussion with the open questions. And the other thing I suggest is that if you're a gynaecologist, if you are a urologist, if you're general practitioners, to say to the person, I know that when people have diabetes or when you have been depressed or when you have given birth, it can be difficult with sexual life Is that something you know and want to talk about? So that's also to normalise it and say it's not specifically you. I know every time I see a woman or every time I've seen a man in your situation, I will ask him thi question, that normalises it.
DAVID RALPH : Yeah, I agree with you Annanaria. I think to say to the patient it's extremely common. And all my patients or most of my patients have this sort of issue. Do you have any, you know, erection problems, keep it fairly general terms, then it's for them to then come back. But you have opened the question.
MICHAEL SMITH : So this with no particular order, it seems like we're darting from topic to topic. Someone's asked about risk of flammable risk during sex and I'm presume they're talking about candles, et cetera. We're we're told to be careful with emollient and hairsprays. Is someone going to set their genitalia or a light on with this?
ANNAMARIA GIRALDI : Put your penis in the light?
DAVID RALPH : No, I don't think, I mean it's a small little pea size blob of gel that you are rubbing on. Yes, in operating theatres when we're sort of washing the patient in alcohol, we make sure it dries. And before, you know, anyone uses any of the equipment. But I doubt whether there's going to be any problems.
ANNAMARIA GIRALDI : I think we have used hand sanitizers for years now during covid and I don't think that has been an issue with the them being flammable.
GERALD BROCK : Yeah, right. And this apparently evaporates within 15 seconds. So you'd have to light your penis with a match very quickly after you apply Eroxon.
DAVID RALPH : I think it's dropping your cigarette onto your penis there Gerry.
MICHAEL SMITH : We're going-
GERALD BROCK : I thought it was very rapid sexual activity that actually...
MICHAEL SMITH : I thought you had a cigarette after sex Professor Ralph. So with regards to someone's asked here, is this safe? Is it safe and feasible within oral sex? I presume from what we've heard earlier, is that a yes?
DAVID RALPH : Yes, it's safe apart from the taste, sort of a bittersweet taste, but yeah, I mean it's safe.
MICHAEL SMITH : And with regards to any patients that shouldn't be using this, are there any patients that it's contraindicated in?
DAVID RALPH : Well, I think the answer is no to that, but we all as physicians realise that erectile dysfunction is a marker for potential serious underlying health risks, cardiac disease, diabetes, et cetera. So we still want the patients to go to their GP for their general health checks, not just down to the chemist and try this thing out.
GERALD BROCK : Yeah, I would say that being very sort of prescriptive, the information that I give my patients is that if it's sex is exercise and if it's unsafe for that individual to walk a mile in 15 minutes or walk up two flights of stairs because as David talked about they have underlying cardiovascular disease or cardiac ischemia, then they shouldn't engage in sex. But this product doesn't change that it doesn't protect the individual and it doesn't put them at greater risk. It's their underlying health that would be the limitation for them to be involved in intercourse.
MICHAEL SMITH : I think this next question, it's sort of been answered, but perhaps we could elaborate more on it because I think that it's come up in a couple of different forms in the audience. So perhaps we do need to go back to it a bit. It's more about, and I'll summarise them 'cause I'm bundling three questions into one. We have highly effective treatments for erectile dysfunction at the moment. Do we really need a new product on the market? And that's, I'm summarising three questions in one there and I know we've touched that earlier.
ANNAMARIA GIRALDI : I would like to start, I think yes, the more the better. And I think that I always see that we have a toolbox and we have a toolbox that the more things we have in it, the better. Because we have so many barriers and so many different patients. And as we discussed, some patients don't want to take a pill. Some patients are allowed to take a pill. Some patients will think this is so nice because I don't have to get a prescription, I don't need to go to see a doctor. Some patients will think it's more natural, some patients will think this is nice because I can include my partner more or the partner might say, "I prefer this." I mean that's, as we discussed before, some partners have really strong opinions against taking a pill. So I think that it's not because the other treatments are bad, it's because if we have more treatments, we have more variety in what we can actually give to our patients. And I work with women also and one of the problems we have is that we have almost nothing in the toolbox. So I think that there, we really see how limited that makes the clinicians and in the end the patients, because we don't have enough to offer. So I think we can individualise the treatment much more.
DAVID RALPH : And medicine doesn't stay still. I mean you've got patients complaining, "Oh nothing's happened, since the Viagra sort of 10, 15 years ago. We haven'thad anything new," well you've got something new now and hopefully we'll have something new in the future as well. So I think, you know, we mustn't stop advances and keep trying to get better products.
ANNAMARIA GIRALDI : And I think the topical application is something we discussed before we had the PDE5 inhibitors but So, but we never had a good product that we could actually use, so it's not a new idea but it's not just a new product.
GERALD BROCK : Actually we did trials with a topical prostaglandin E1 that looked like it was going to be approved but had such bad side effects and poor efficacy that didn't make it really make to the market. I agree with the others, I think that more is better, but I think this has enough differentiating factors that does differentiate it from the other oral available treatments or the injectable or the inter urethral and certainly different than surgery. I think this would probably be really the least invasive of currently available therapies because it doesn't work systemically, because it isn't ingested, because it's very fast, because it is available over the counters. All of those differentiating factors I think add to the repertoire of what we can offer patients and what patients can access directly going to the pharmacy. So I think that, do we need it? I think it's an advantage.
MICHAEL SMITH : So, and once again I know that we've covered some of this earlier, but I think there's a slight different slant on this question. Someone asked, "Do you see this suited towards younger men with perhaps erectile confidence issues or do you see this with sort of older men with more physiological causes?" And there's a sweeping generalisation there, but I think the theme of it is, do you see it with sort of old people more likely to have diabetes metabolic syndrome or do you see this as younger people with competent or does it not matters? Does it go right across the page?
DAVID RALPH : Well, I think the patients are going to... it doesn't matter about the age, the patients would prefer to have this sort of topical therapy, but as you said, you know, with advance in ages than you would expect the erectile dysfunction to be more severe. So that's just how it is. But I think from a patient preference, it doesn't matter what age they are.
ANNAMARIA GIRALDI : I think sometimes when we say something is more severe when you are older, I think some of the men I see that are young, where I think the mechanistics are really working, but they have such a huge anxiety of performance anxiety. I think this is really going to be nice because it's going to be different. It's not that they're, sometimes if they need to take a tablet they sit there for an hour and they get more performance anxiety because they sit there and wait and they know now I have to perform in one hour. I know the drug is going to work and I think this is going to be a little bit different. And you don't have to give them a drug, but you can say, "Maybe you can try this." And I think that's, at least I can see my clinical practise that I really think that will add on to the treatment of especially the young men with performance anxiety.
GERALD BROCK : You know, on average I see anywhere from 1500 to 2000 new consults a year in my clinical practise for erectile dysfunction. And I can tell you that obviously I have a large experience as the others do. But I'm constantly embarrassed when I try and predict who's going to respond to which medication. I have an old guy who is in front of me who has vascular disease and I'm thinking to myself, I'm going to prescribe him some Viagra, but the chance it's going to work is going to be like basically zero. It's a waste of his time and money. And he comes back six weeks later and he says, this is the greatest drug on earth. And I have a young guy who I say, well I just need him to sniff a tablet of Viagra and he's going to respond 'cause it's all non-organic. And he comes back and he says it did nothing. So in terms of sexual function and predicting who's going to respond to which treatment, I'm really not very good. And so I guess what I'm trying to say is I wouldn't try and pigeonhole this treatment for a particular category or age. And I think that at the end of the day, the consumers will tell us who it responds
and who doesn't respond.
MICHAEL SMITH : So just as a follow up, that Professor Brock, 'cause someone's asked this question, so they're asking, is this a first line treatment? From what you've just said, it doesn't fit in terms of chronicity of where you treat it's not necessarily a first line treatment, it's one of the treatments. Is that where you would you'd answer that question?
GERALD BROCK : Well, it depends on how you characterise first line treatment. And I would say a first line treatment should be the treatment that you go to first because it is highly effective, very safe, widely available and has a low cost basis. And if it has those characteristics, then it meets the criteria for first line therapy. And I would say that Eroxon right now, I don't know the cost, but certainly that's available. It is non-toxic, it's going to be widely available, it works quickly. So it has a number of the characteristics which I would consider first line therapy.
MICHAEL SMITH : So as we're approaching the end, perhaps 20 seconds from each of the panel, just to sort of sum up exactly what you'd like people to take home from this webinar. I'll start in the way that we start at the beginning. So Professor Ralph, if you could give your summary.
DAVID RALPH : Thank you Michael, and thank you for allowing me to come onto this webinar. But basically patients want topical therapy all over the world. If you ask a patient, "Do you want a little bit of cream to rub on?" That's what they want, so topical therapy is what they want. It needs to be effective and safe.
MICHAEL SMITH : Professor Brock?
GERALD BROCK : Yeah, I agree with David. It's local, it's not toxic. There's no active pharmaceutical agent to it. I think it has a number of characteristics that make it a really nice way for patients to take care of their perceived erectile dysfunction. And at the end of the day, we'll see what the response rate is in the real world. But it's nice that we have clinical studies that show that it is safe and effective.
MICHAEL SMITH : And of course Professor Giraldi.
ANNAMARIA GIRALDI : Yeah, thank you for having me here. And I think I just want to add on to what my colleague says. I think it's over the counter. It's a rapid time of action and it invites to include the partner much more than many other treatments do.
MICHAEL SMITH : So I think we are rapidly approaching the end and I'd like to first of all say that, I'd like to hope that the information that people listening to the webinar today, it's going to be hopeful for you in how you're going to widen the treatment for those seeking treatment for erectile dysfunction. First of all, I wanted to say thanks to our expert panel Professor Ralph, Professor Brock, and of course Professor Giraldi. Thanks for making thisa really informative and successful event. I know I've learned an awful lot. I think the audience would agree that your expertise and dedication has been absolutely instrumental in today's webinar being so successful. To the audience that's listened to us, I'd like to thank you for joining us today and for your active participation. Some excellent questions and I think they added depth and richness to this conversation that we've had today and help me understand some of the greater issues. So as we approach the end of the webinar, I would like to say on behalf of the panel and myself, thank you very much for attending and we really hope to see you at future events. Thank you, and goodbye.