FDA OKs Over-the-Counter Gel for Erectile Dysfunction

[Nelson Vergel]

It does sound rather scammy with the proposed way of working, with paid "experts" promoting it. The question is how it got through clinical studies and European and FDA approval.

Also it is highly overpriced for a simple waterless alcohol/propylene glycol gel, that's why they have to hype it up like that.

They are misleading people. They did not get “approved” by the FDA. They got “cleared” as a device. Not a hard thing to get.

 

[DorianGray]

Now that I've read through everything my optimism has gone limp.

 

[SSHSSA74]

It is hard for me to believe this. Let's see when we try it out.

The FDA has given MED3000 (Eroxon), the first nonprescription topical gel for treating erectile dysfunction (ED) in men over the age of 22, permission to be sold without a prescription. The company that makes it, Futura Medical, revealed this on Monday.

The company says that MED3000 has "a 10-minute onset of action" that makes it different from prescription PDE5 inhibitors like sildenafil (Viagra) and tadalafil (Cialis), which usually take longer to work.

The non-medicated hydro-alcoholic gel was first used as a placebo in studies of a nitroglycerin gel the company was making, but it turned out that MED3000 worked just as well in a big phase III trialopens in a new tab or window.

US FDA Grants for Over-the-Counter Marketing Authorization to Futura for Fast-Acting Topical Gel, MED3000, to Treat Erectile Dysfunction

Futura Medical plc (AIM: FUM) (“Futura” or the “Company”), a pharmaceutical company developing a portfolio of innovative products based on its proprie

www.businesswire.com

Highly positive FM71 Phase 3 Study Results with all primary and secondary endpoints achieved, MED3000 remains on track to obtain US FDA marketing authorisation



Futura Medical plc (AIM: FUM), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology and currently focused on sexual health and pain, today announces positive results from the confirmatory Phase 3 clinical study, "FM71" for MED3000 for the treatment of erectile dysfunction ("ED").

FDA agreed co-primary endpoints met at 24 weeks, demonstrating a statistically significant improvement in erectile function compared to baseline, as well as achieving a clinically important improvement in erectile function at 24 weeks

Secondary endpoint met demonstrating a 10-minute onset of action, which was demonstrably faster than the well-known prescription oral medication used in the study

Exploratory endpoints demonstrated MED3000 achieved clinically important improvements in erectile function at all time points and was clinically effective in mild, moderate and severe ED sufferers

Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patients on MED3000 and overall, with a highly favourable side-effect profile

MED3000 presents an effective clinically proven treatment for erectile dysfunction ("ED") with a rapid speed of onset and a favourable benefit versus risk profile ideally suited for Over the Counter ("OTC") classification1
Futura on track to file dossier with the US FDA by the end of September, targeting marketing authorisation by the FDA of MED3000 in Q1 2023 as the first major ED treatment available OTC throughout the USA


MED3000 is a breakthrough, fast acting topical gel formulation for the treatment of ED and is CE marked in Europe and CA marked in the UK, as a clinically proven topical treatment for adult men with ED that helps men get an erection within 10 minutes.



FM71 results are highly positive, in line with data generated in the previous Phase 3 clinical study ("FM57") and broadly comparable with results from a recent "real world", home use study.


Accumulated MED3000 clinical data demonstrates that it presents an effective treatment option with a rapid onset of action and a favourable risk versus benefit profile ideally suited for OTC classification1. It is expected to provide an alternative to existing ED treatments, that require a doctor's prescription, for those patients seeking fewer systemic side-effects, and a spontaneous intercourse experience. It also provides an important treatment option for those patients who are currently precluded from using current prescription treatments such as those men taking nitrate medication.



FM71 Trial Design

FM71 is a multi-centre, randomised, open-label, home use, parallel group, clinical investigation of topically applied MED3000 gel compared to oral tadalafil (5mg) tablets for the treatment of ED over a 24-week period. The trial design and clinical endpoints were agreed with the FDA as a confirmatory clinical trial for the US regulatory dossier for MED3000 which we continue to target filing by the end of September 2022.



FM71 investigated the efficacy and safety of MED3000 gel in 96 male patients clinically diagnosed with a mix of mild, moderate and severe ED against baseline (pre-treatment). Subjects were recruited from United States (African Americans), Poland, Georgia and Bulgaria and included men who had organic and psychological ED or a combination of both.



Patients enrolled into the FM71 study for the initial four weeks had to attempt intercourse on at least four occasions in order to establish the severity of their ED known as the 'baseline', after which MED3000 was used as per trial protocol for 24 weeks.



Efficacy - Co-Primary Endpoints

Co-primary endpoints pre-determined with the FDA were achieved for MED3000. The first showed a highly statistically significant improvement, P<0.001, against baseline at 24 weeks in erectile function (as measured by the gold standard, internationally recognised IIEF-EF score) across 'pooled' severities of ED (mild, moderate and severe). The 24-week time point demonstrated durability of response to treatment beyond 12 weeks (studied previously in FM57) which was specifically requested by the FDA.



The second primary endpoint, again using the IIEF-EF scale, showed that on average patients experienced a 5.73 unit change in IIEF-EF score versus baseline at 24 weeks exceeding the 4-unit difference agreed with the FDA and defined as the Minimal Clinical Important Difference ("MCID"). This standard, as defined in scientific papers by Rosen et al2, is internationally accepted as a key criterion demonstrating meaningful difference in improvement of erections, and therefore is of clear benefit to patients.



Onset of Action - Secondary Endpoints

FM71 also included FDA agreed criteria for proving a rapid onset of action. Data demonstrated a highly statistically significant improvement, P<0.001, at 10 minutes where patients noticed an erection. Oral tadalafil (5mg tablets) did not meet the criteria at the same time point. Oral tablets typically take 30-60 minutes to work and therefore a claim for MED3000 such as "helps you get an erection within 10 minutes" represents a significant advancement in therapy over existing oral tablets.



Exploratory Endpoints

A number of exploratory endpoints were studied with key highlights as follows:

Using the well-established Self Esteem and Relationship (SEAR) questionnaire, it was determined that at week 24, 85.4% of MED3000 users felt that sex could be spontaneous (includes: Always/Almost Always/Most times/Sometimes), reaffirming the rapid onset of action and key user benefit
Using the IIEF-EF scale, MED3000 was shown to exceed the MCID of 4 units at each time point; 4 weeks (4.59 units), 8 weeks (5.20), 12 weeks (5.12), 16 weeks (5.83), 20 weeks (5.57) and 24 weeks (5.73). Generally, there was an improvement in IIEF-EF score over the 24-week duration of the study and importantly there was no decline in efficacy between 12 and 24 weeks. The potential for a decline in efficacy between 12 and 24 weeks had been previously raised by the FDA as a potential issue
An average of results over the 24 weeks, showed that MED3000 exceeded the MCID for subgroups of mild, moderate and severe ED sufferers


Safety and Tolerability

Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patients on MED3000 with a highly favourable overall side-effect profile. Of particular note is that 19.1% of tadalafil users experienced a headache on at least one occasion whilst using the product versus 4.3% of MED3000 users; headache is a known side-effect of prescription oral medications for ED. 4.3% tadalafil users also noted back pain and 4.3% "non-cardiac" chest pain (three cases of moderate and one mild in the US population). No instances of back pain or chest pain were noted with MED3000 although 4.3% users noted nausea (two subjects). Only one instance of mild local burning was noted in MED3000 users and no instances of local side-effects in female partners.



Summary comparison of MED3000 versus tadalafil in FM71

Both MED3000 and tadalafil exceeded the minimal clinically important differences at all time points and for all ED severities however overall tadalafil showed a greater improvement in erectile function than MED3000. MED3000 achieved the FDA agreed criteria for proving a rapid onset of action at 10 minutes where patients noticed an erection whereas tadalafil did not achieve the agreed criteria. MED3000 also showed a more favourable side effect profile compared to tadalafil.



Comparison of FM71 with previously conducted Phase 3 clinical trial, FM57

Data from the FM71 study reaffirms previously published results from FM57, which showed MED3000 to be rapid-acting with first signs of erection within 10 minutes. At 4, 8 and 12-week time points highly statistically superior improvement over baseline was achieved with very similar IIEF-EF scores in both studies. Safety and tolerability data was also consistent with FM57, with no serious adverse events recorded in any patient or their female partner on MED3000 as well as a highly favourable overall side effect profile.



Next Steps

As previously announced, the FDA has agreed that an application may be made for MED3000 as a medical device for ED treatment, with a De Novo classification. Data from this confirmatory clinical study, FM71, alongside additional data from FM57, supports the US regulatory submission for MED3000 with an application for OTC designation. The dossier is on track for submission at the end of September 2022.



US marketing authorisation of MED3000 by the FDA remains on course for Q1 2023.

Very interesting. Gonna check it out.

 

[vinnylid]

There is a lot of responses about this product on the Frank Talk forum. It does not appear to work for anyone. It appears to be simply a placebo.

 

[sammmy]

Just another example that one should not trust "studies" done by the manufacturer.

 

[sbstrum_MD]

Here is the private investigator in the US:


Arthur Louis Burnett, MD is a professor of urology at the Johns Hopkins School of Medicine. He is the Patrick C. Walsh Professor of Urology and the director of the Male Consultation Clinic at Johns Hopkins Hospital
. Dr. Burnett is also a clinician-scientist at the James Buchanan Brady Urological Institute and director of the Basic Science Laboratory in Neurourology at the Johns Hopkins School of Medicine
. He received his undergraduate degree in biology from Princeton University and his medical degree at the Johns Hopkins University School of Medicine
. He completed his internship and residency in surgery, and subsequently residency and fellowship in urology at The Johns Hopkins Hospital
. Dr. Burnett has written extensively on the regulatory mechanisms of penile erection

I cannot find any publication by Burnett on Eroxon (MED3000) using PubMed. Do you know of any peer-reviewed paper that has been published on this? Burnett has many publications on ED. Note that I am not counting the trial on ClinicalTrials.gov as a peer-reviewed article.


Study : Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction - Full Text View - ClinicalTrials.gov

 

[Ribeye]

It is hard for me to believe this. Let's see when we try it out.

The FDA has given MED3000 (Eroxon), the first nonprescription topical gel for treating erectile dysfunction (ED) in men over the age of 22, permission to be sold without a prescription. The company that makes it, Futura Medical, revealed this on Monday.

The company says that MED3000 has "a 10-minute onset of action" that makes it different from prescription PDE5 inhibitors like sildenafil (Viagra) and tadalafil (Cialis), which usually take longer to work.

The non-medicated hydro-alcoholic gel was first used as a placebo in studies of a nitroglycerin gel the company was making, but it turned out that MED3000 worked just as well in a big phase III trialopens in a new tab or window.

US FDA Grants for Over-the-Counter Marketing Authorization to Futura for Fast-Acting Topical Gel, MED3000, to Treat Erectile Dysfunction

Futura Medical plc (AIM: FUM) (“Futura” or the “Company”), a pharmaceutical company developing a portfolio of innovative products based on its proprie

www.businesswire.com

Highly positive FM71 Phase 3 Study Results with all primary and secondary endpoints achieved, MED3000 remains on track to obtain US FDA marketing authorisation



Futura Medical plc (AIM: FUM), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology and currently focused on sexual health and pain, today announces positive results from the confirmatory Phase 3 clinical study, "FM71" for MED3000 for the treatment of erectile dysfunction ("ED").

FDA agreed co-primary endpoints met at 24 weeks, demonstrating a statistically significant improvement in erectile function compared to baseline, as well as achieving a clinically important improvement in erectile function at 24 weeks

Secondary endpoint met demonstrating a 10-minute onset of action, which was demonstrably faster than the well-known prescription oral medication used in the study

Exploratory endpoints demonstrated MED3000 achieved clinically important improvements in erectile function at all time points and was clinically effective in mild, moderate and severe ED sufferers

Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patients on MED3000 and overall, with a highly favourable side-effect profile

MED3000 presents an effective clinically proven treatment for erectile dysfunction ("ED") with a rapid speed of onset and a favourable benefit versus risk profile ideally suited for Over the Counter ("OTC") classification1
Futura on track to file dossier with the US FDA by the end of September, targeting marketing authorisation by the FDA of MED3000 in Q1 2023 as the first major ED treatment available OTC throughout the USA


MED3000 is a breakthrough, fast acting topical gel formulation for the treatment of ED and is CE marked in Europe and CA marked in the UK, as a clinically proven topical treatment for adult men with ED that helps men get an erection within 10 minutes.



FM71 results are highly positive, in line with data generated in the previous Phase 3 clinical study ("FM57") and broadly comparable with results from a recent "real world", home use study.


Accumulated MED3000 clinical data demonstrates that it presents an effective treatment option with a rapid onset of action and a favourable risk versus benefit profile ideally suited for OTC classification1. It is expected to provide an alternative to existing ED treatments, that require a doctor's prescription, for those patients seeking fewer systemic side-effects, and a spontaneous intercourse experience. It also provides an important treatment option for those patients who are currently precluded from using current prescription treatments such as those men taking nitrate medication.



FM71 Trial Design

FM71 is a multi-centre, randomised, open-label, home use, parallel group, clinical investigation of topically applied MED3000 gel compared to oral tadalafil (5mg) tablets for the treatment of ED over a 24-week period. The trial design and clinical endpoints were agreed with the FDA as a confirmatory clinical trial for the US regulatory dossier for MED3000 which we continue to target filing by the end of September 2022.



FM71 investigated the efficacy and safety of MED3000 gel in 96 male patients clinically diagnosed with a mix of mild, moderate and severe ED against baseline (pre-treatment). Subjects were recruited from United States (African Americans), Poland, Georgia and Bulgaria and included men who had organic and psychological ED or a combination of both.



Patients enrolled into the FM71 study for the initial four weeks had to attempt intercourse on at least four occasions in order to establish the severity of their ED known as the 'baseline', after which MED3000 was used as per trial protocol for 24 weeks.



Efficacy - Co-Primary Endpoints

Co-primary endpoints pre-determined with the FDA were achieved for MED3000. The first showed a highly statistically significant improvement, P<0.001, against baseline at 24 weeks in erectile function (as measured by the gold standard, internationally recognised IIEF-EF score) across 'pooled' severities of ED (mild, moderate and severe). The 24-week time point demonstrated durability of response to treatment beyond 12 weeks (studied previously in FM57) which was specifically requested by the FDA.



The second primary endpoint, again using the IIEF-EF scale, showed that on average patients experienced a 5.73 unit change in IIEF-EF score versus baseline at 24 weeks exceeding the 4-unit difference agreed with the FDA and defined as the Minimal Clinical Important Difference ("MCID"). This standard, as defined in scientific papers by Rosen et al2, is internationally accepted as a key criterion demonstrating meaningful difference in improvement of erections, and therefore is of clear benefit to patients.



Onset of Action - Secondary Endpoints

FM71 also included FDA agreed criteria for proving a rapid onset of action. Data demonstrated a highly statistically significant improvement, P<0.001, at 10 minutes where patients noticed an erection. Oral tadalafil (5mg tablets) did not meet the criteria at the same time point. Oral tablets typically take 30-60 minutes to work and therefore a claim for MED3000 such as "helps you get an erection within 10 minutes" represents a significant advancement in therapy over existing oral tablets.



Exploratory Endpoints

A number of exploratory endpoints were studied with key highlights as follows:

Using the well-established Self Esteem and Relationship (SEAR) questionnaire, it was determined that at week 24, 85.4% of MED3000 users felt that sex could be spontaneous (includes: Always/Almost Always/Most times/Sometimes), reaffirming the rapid onset of action and key user benefit
Using the IIEF-EF scale, MED3000 was shown to exceed the MCID of 4 units at each time point; 4 weeks (4.59 units), 8 weeks (5.20), 12 weeks (5.12), 16 weeks (5.83), 20 weeks (5.57) and 24 weeks (5.73). Generally, there was an improvement in IIEF-EF score over the 24-week duration of the study and importantly there was no decline in efficacy between 12 and 24 weeks. The potential for a decline in efficacy between 12 and 24 weeks had been previously raised by the FDA as a potential issue
An average of results over the 24 weeks, showed that MED3000 exceeded the MCID for subgroups of mild, moderate and severe ED sufferers


Safety and Tolerability

Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patients on MED3000 with a highly favourable overall side-effect profile. Of particular note is that 19.1% of tadalafil users experienced a headache on at least one occasion whilst using the product versus 4.3% of MED3000 users; headache is a known side-effect of prescription oral medications for ED. 4.3% tadalafil users also noted back pain and 4.3% "non-cardiac" chest pain (three cases of moderate and one mild in the US population). No instances of back pain or chest pain were noted with MED3000 although 4.3% users noted nausea (two subjects). Only one instance of mild local burning was noted in MED3000 users and no instances of local side-effects in female partners.



Summary comparison of MED3000 versus tadalafil in FM71

Both MED3000 and tadalafil exceeded the minimal clinically important differences at all time points and for all ED severities however overall tadalafil showed a greater improvement in erectile function than MED3000. MED3000 achieved the FDA agreed criteria for proving a rapid onset of action at 10 minutes where patients noticed an erection whereas tadalafil did not achieve the agreed criteria. MED3000 also showed a more favourable side effect profile compared to tadalafil.



Comparison of FM71 with previously conducted Phase 3 clinical trial, FM57

Data from the FM71 study reaffirms previously published results from FM57, which showed MED3000 to be rapid-acting with first signs of erection within 10 minutes. At 4, 8 and 12-week time points highly statistically superior improvement over baseline was achieved with very similar IIEF-EF scores in both studies. Safety and tolerability data was also consistent with FM57, with no serious adverse events recorded in any patient or their female partner on MED3000 as well as a highly favourable overall side effect profile.



Next Steps

As previously announced, the FDA has agreed that an application may be made for MED3000 as a medical device for ED treatment, with a De Novo classification. Data from this confirmatory clinical study, FM71, alongside additional data from FM57, supports the US regulatory submission for MED3000 with an application for OTC designation. The dossier is on track for submission at the end of September 2022.



US marketing authorisation of MED3000 by the FDA remains on course for Q1 2023.

Does anyone have any idea what it does to be effective? what drug pathway it uses or how it affects blood flow? Is it a PDE 5 inhibitor in a quick acting topical or does it have some other mechanism of action?

 

[madman]

Does anyone have any idea what it does to be effective? what drug pathway it uses or how it affects blood flow? Is it a PDE 5 inhibitor in a quick acting topical or does it have some other mechanism of action?

Does anyone have any idea what it does to be effective? what drug pathway it uses or how it affects blood flow?

*Stimulates nerve sensors by a cooling and recovery warming effect

*The evaporative mode of action leads to smooth muscle relaxation


Is it a PDE 5 inhibitor in a quick acting topical or does it have some other mechanism of action?

No.

 

[KevinS]

Huh? well that was kind of a roller coaster ride. Sounded great at first - would still probably still give it a try if it wasn't too expensive and easy to get.

 

[DorianGray]

Huh? well that was kind of a roller coaster ride. Sounded great at first - would still probably still give it a try if it wasn't too expensive and easy to get.

Well, what the heck, I'm going to squeeze a whole tube on.

 

[appleheadq]

From the internet:

"This reconfirms the significant opportunity that MED3000 represents with OTC availability at a likely retail price in the region of US$5 per dose in the USA."

Pricey it seems compared to the 90ct Tadalafil I just got for $6.50.

Dorian, I would be interested in finding out where you are buying Tadalafil 90 ct for $6.50 at? I am paying a lot more than that and can't afford to take it that often due to price.
Thanks,
Chris

 

[Simbarn]

There is a lot of responses about this product on the Frank Talk forum. It does not appear to work for anyone. It appears to be simply a placebo.

Correct. We have been following this since its inception at Frank talk. I remember when it was first announced and the mode of action was described, I thought, this sounds like a scam. As it turns out years later; not one positive review yet on the forum.
I recently tried Rectogesic cream on the head of my penis as an experiment, and it did cause a partial erection without any stimulation that lasted for a few minutes. This is because it actually has a drug in it, unlike Eroxon: Glyceryl trinitrate 2%.
The company manufacturing Eroxon has been quite clever, as think about big companies like L'Oreal who market "over the counter" skin creams that claim all sorts of anti-aging properties and in fact do very little other than moisturise the skin... People still buy them in droves. The supplement industry is also quite similar.
They will probably sell huge amounts of the product. Placebo sells!
They also know, men with ED are desperate, and will try anything, especially if it is easy to procure.

 

[DorianGray]

Dorian, I would be interested in finding out where you are buying Tadalafil 90 ct for $6.50 at? I am paying a lot more than that and can't afford to take it that often due to price.
Thanks,
Chris

I get the prescription from my physician and have it filled at Safeway ( a supermarket) Pharmacy. I use a GoodRx coupon. It just happened to be $6.50 last time. But, I usually pay anywhere from $9-12. The coupon prices vary.

 

[JmarkH]

I get tadalafil from CostPlus [90 day 10mg] for $11 + $5 shipping.

 

[DorianGray]

I get tadalafil from CostPlus [90 day 10mg] for $11 + $5 shipping.

I didn't know Mark Cuban had a drug company. Dang nice pricing.

 

[DadOfSonNOVA]

Found it on Amazon. One month delivery:

It is applied on the head of the penis.

Eroxon StimGel Treatment Gel for Erectile Dysfunction - 4 Single Dose Tubes Amazon.com

$100/4 doses, so $25/dose

 

[Nelson Vergel]

It’s crap

 

[Ribeye]

I hear it is now available in Europe.

Has been available in Europe for at least a year or two. Bottom line, didn't work as well as 5 mg tadalafil. Faster for those who do get a benefit. But the cost is high, compared to the benefit.

 

[threeXweekstill]

It is hard for me to believe this. Let's see when we try it out.

The FDA has given MED3000 (Eroxon), the first nonprescription topical gel for treating erectile dysfunction (ED) in men over the age of 22, permission to be sold without a prescription. The company that makes it, Futura Medical, revealed this on Monday.

The company says that MED3000 has "a 10-minute onset of action" that makes it different from prescription PDE5 inhibitors like sildenafil (Viagra) and tadalafil (Cialis), which usually take longer to work.

The non-medicated hydro-alcoholic gel was first used as a placebo in studies of a nitroglycerin gel the company was making, but it turned out that MED3000 worked just as well in a big phase III trialopens in a new tab or window.

US FDA Grants for Over-the-Counter Marketing Authorization to Futura for Fast-Acting Topical Gel, MED3000, to Treat Erectile Dysfunction

Futura Medical plc (AIM: FUM) (“Futura” or the “Company”), a pharmaceutical company developing a portfolio of innovative products based on its proprie

www.businesswire.com

Highly positive FM71 Phase 3 Study Results with all primary and secondary endpoints achieved, MED3000 remains on track to obtain US FDA marketing authorisation



Futura Medical plc (AIM: FUM), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology and currently focused on sexual health and pain, today announces positive results from the confirmatory Phase 3 clinical study, "FM71" for MED3000 for the treatment of erectile dysfunction ("ED").

FDA agreed co-primary endpoints met at 24 weeks, demonstrating a statistically significant improvement in erectile function compared to baseline, as well as achieving a clinically important improvement in erectile function at 24 weeks

Secondary endpoint met demonstrating a 10-minute onset of action, which was demonstrably faster than the well-known prescription oral medication used in the study

Exploratory endpoints demonstrated MED3000 achieved clinically important improvements in erectile function at all time points and was clinically effective in mild, moderate and severe ED sufferers

Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patients on MED3000 and overall, with a highly favourable side-effect profile

MED3000 presents an effective clinically proven treatment for erectile dysfunction ("ED") with a rapid speed of onset and a favourable benefit versus risk profile ideally suited for Over the Counter ("OTC") classification1
Futura on track to file dossier with the US FDA by the end of September, targeting marketing authorisation by the FDA of MED3000 in Q1 2023 as the first major ED treatment available OTC throughout the USA


MED3000 is a breakthrough, fast acting topical gel formulation for the treatment of ED and is CE marked in Europe and CA marked in the UK, as a clinically proven topical treatment for adult men with ED that helps men get an erection within 10 minutes.



FM71 results are highly positive, in line with data generated in the previous Phase 3 clinical study ("FM57") and broadly comparable with results from a recent "real world", home use study.


Accumulated MED3000 clinical data demonstrates that it presents an effective treatment option with a rapid onset of action and a favourable risk versus benefit profile ideally suited for OTC classification1. It is expected to provide an alternative to existing ED treatments, that require a doctor's prescription, for those patients seeking fewer systemic side-effects, and a spontaneous intercourse experience. It also provides an important treatment option for those patients who are currently precluded from using current prescription treatments such as those men taking nitrate medication.



FM71 Trial Design

FM71 is a multi-centre, randomised, open-label, home use, parallel group, clinical investigation of topically applied MED3000 gel compared to oral tadalafil (5mg) tablets for the treatment of ED over a 24-week period. The trial design and clinical endpoints were agreed with the FDA as a confirmatory clinical trial for the US regulatory dossier for MED3000 which we continue to target filing by the end of September 2022.



FM71 investigated the efficacy and safety of MED3000 gel in 96 male patients clinically diagnosed with a mix of mild, moderate and severe ED against baseline (pre-treatment). Subjects were recruited from United States (African Americans), Poland, Georgia and Bulgaria and included men who had organic and psychological ED or a combination of both.



Patients enrolled into the FM71 study for the initial four weeks had to attempt intercourse on at least four occasions in order to establish the severity of their ED known as the 'baseline', after which MED3000 was used as per trial protocol for 24 weeks.



Efficacy - Co-Primary Endpoints

Co-primary endpoints pre-determined with the FDA were achieved for MED3000. The first showed a highly statistically significant improvement, P<0.001, against baseline at 24 weeks in erectile function (as measured by the gold standard, internationally recognised IIEF-EF score) across 'pooled' severities of ED (mild, moderate and severe). The 24-week time point demonstrated durability of response to treatment beyond 12 weeks (studied previously in FM57) which was specifically requested by the FDA.



The second primary endpoint, again using the IIEF-EF scale, showed that on average patients experienced a 5.73 unit change in IIEF-EF score versus baseline at 24 weeks exceeding the 4-unit difference agreed with the FDA and defined as the Minimal Clinical Important Difference ("MCID"). This standard, as defined in scientific papers by Rosen et al2, is internationally accepted as a key criterion demonstrating meaningful difference in improvement of erections, and therefore is of clear benefit to patients.



Onset of Action - Secondary Endpoints

FM71 also included FDA agreed criteria for proving a rapid onset of action. Data demonstrated a highly statistically significant improvement, P<0.001, at 10 minutes where patients noticed an erection. Oral tadalafil (5mg tablets) did not meet the criteria at the same time point. Oral tablets typically take 30-60 minutes to work and therefore a claim for MED3000 such as "helps you get an erection within 10 minutes" represents a significant advancement in therapy over existing oral tablets.



Exploratory Endpoints

A number of exploratory endpoints were studied with key highlights as follows:

Using the well-established Self Esteem and Relationship (SEAR) questionnaire, it was determined that at week 24, 85.4% of MED3000 users felt that sex could be spontaneous (includes: Always/Almost Always/Most times/Sometimes), reaffirming the rapid onset of action and key user benefit
Using the IIEF-EF scale, MED3000 was shown to exceed the MCID of 4 units at each time point; 4 weeks (4.59 units), 8 weeks (5.20), 12 weeks (5.12), 16 weeks (5.83), 20 weeks (5.57) and 24 weeks (5.73). Generally, there was an improvement in IIEF-EF score over the 24-week duration of the study and importantly there was no decline in efficacy between 12 and 24 weeks. The potential for a decline in efficacy between 12 and 24 weeks had been previously raised by the FDA as a potential issue
An average of results over the 24 weeks, showed that MED3000 exceeded the MCID for subgroups of mild, moderate and severe ED sufferers


Safety and Tolerability

Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patients on MED3000 with a highly favourable overall side-effect profile. Of particular note is that 19.1% of tadalafil users experienced a headache on at least one occasion whilst using the product versus 4.3% of MED3000 users; headache is a known side-effect of prescription oral medications for ED. 4.3% tadalafil users also noted back pain and 4.3% "non-cardiac" chest pain (three cases of moderate and one mild in the US population). No instances of back pain or chest pain were noted with MED3000 although 4.3% users noted nausea (two subjects). Only one instance of mild local burning was noted in MED3000 users and no instances of local side-effects in female partners.



Summary comparison of MED3000 versus tadalafil in FM71

Both MED3000 and tadalafil exceeded the minimal clinically important differences at all time points and for all ED severities however overall tadalafil showed a greater improvement in erectile function than MED3000. MED3000 achieved the FDA agreed criteria for proving a rapid onset of action at 10 minutes where patients noticed an erection whereas tadalafil did not achieve the agreed criteria. MED3000 also showed a more favourable side effect profile compared to tadalafil.



Comparison of FM71 with previously conducted Phase 3 clinical trial, FM57

Data from the FM71 study reaffirms previously published results from FM57, which showed MED3000 to be rapid-acting with first signs of erection within 10 minutes. At 4, 8 and 12-week time points highly statistically superior improvement over baseline was achieved with very similar IIEF-EF scores in both studies. Safety and tolerability data was also consistent with FM57, with no serious adverse events recorded in any patient or their female partner on MED3000 as well as a highly favourable overall side effect profile.



Next Steps

As previously announced, the FDA has agreed that an application may be made for MED3000 as a medical device for ED treatment, with a De Novo classification. Data from this confirmatory clinical study, FM71, alongside additional data from FM57, supports the US regulatory submission for MED3000 with an application for OTC designation. The dossier is on track for submission at the end of September 2022.



US marketing authorisation of MED3000 by the FDA remains on course for Q1 2023.

I am an active, in shape, still working full time, 77-year old residing in Florida. I googled, ordered, and received a week later, four single use tubes of this product for about $20 per tube. Followed directions. NO results whatsoever. Anyone else have better luck? Sticking with my Cialis. Works every time for the last ten years, along with my testerone implanted pellets. I'm mainly curious about how others have done with Eroxon because I bought stock in the company a few months back.