Topical gel for erectile dysfunction shows promise in phase 3 trial
Key takeaways
- In a confirmatory study, MED3000 was associated with significant improvements in erectile dysfunction.
- Researchers found that the gel helped people attain an erection more quickly when compared with tadalafil.
- In light of the results, the manufacturer said it is preparing to submit an application to the FDA for marketing authorization.
An investigational therapy for erectile dysfunction met its primary and secondary endpoints in a confirmatory phase 3 clinical study, demonstrating significant improvements at 24 weeks, according to a press release from the manufacturer.
The treatment — MED3000 — is a topically-applied gel developed by Futura Medical. According to the company, the gel is on track to become the first major over-the-counter treatment for erectile dysfunction in the United States.
Erectile dysfunction affects approximately 30 million men in the U.S., according to the CDC. James Barder, CEO of Futura Medical, said in the release that he is “excited at the prospect of bringing a truly differentiated treatment option for men in the USA with [erectile dysfunction] without the need for a doctor’s prescription.”
“In the USA, all clinically proven oral [erectile dysfunction] therapies are prescription-only and therefore MED3000 has the potential to be a significant innovation with its key differentiator of a rapid speed of onset and by creating a major new OTC category for [erectile dysfunction] treatment,” Barder said in the release.
The study, known as FM71, included 96 men with erectile dysfunction who were randomly assigned to receive MED3000 or oral tadalafil tablets over 24 weeks, according to the release.
Researchers found that MED3000 was associated with a “highly statistically significant improvement” in erectile function from baseline to 24 weeks, as measured by the International Index of Erectile Function-Erectile Function (IIEF-EF). This was a primary endpoint predetermined with the FDA.
Researchers also found that the gel helped patients get an erection quickly, a secondary endpoint of the trial. The data, according to the manufacturer, revealed a statistically significant improvement at 10 minutes, which was superior to the oral tadalafil tablets. Typically, those take between half an hour to an hour to work, according to the release.
In terms of exploratory endpoints, at the 24th week, 85.4% of those using MED3000 reported that sex could be spontaneous, “reaffirming the rapid onset of action and key user benefit,” the release said.
The manufacturer also noted that 19.1% of people who use tadalafil report headaches, but only 4.3% of MED3000 users said the same. There was only one incident of mild, local burning, and no serious adverse events, according to the release.
“Data shows that MED3000 is effective across all [erectile dysfunction] patient severities and achieves clinically important efficacy at each time point up to and including 24 weeks. Notably, MED3000 helps men achieve first signs of an erection within 10 minutes, according to predetermined statistical criteria agreed to with the FDA,” Ken James, Futura Medical executive director and head of research and development, said in the release. “MED3000 has also demonstrated excellent safety in comparison with prescription oral medication, and as such, has a very favorable benefit to risk profile making it ideally suited to OTC classification throughout the USA.”
In light of the data, the Futura Medical said it is now “preparing for an FDA regulatory submission near the end of September,” and hopes that MED3000 becomes “the first clinically proven ED product that is approved OTC in Europe and the U.S."
References:
- Diabetes and Men. https://www.cdc.gov/diabetes/library/features/diabetes-and-men.html#:~:text=Erectile%20Dysfunction%20(ED)&text=ED%20is%20common%20in%20middle,the%20United%20States%20have%20it. Accessed Sept. 1, 2022.
- Highly positive FM71 Phase 3 study results with all primary and secondary endpoints achieved, MED3000 remains on track to submit for FDA marketing authorization. https://www.businesswire.com/news/home/20220831005232/en/Highly-positive-FM71-Phase-3-study-results-with-all-primary-and-secondary-endpoints-achieved-MED3000-remains-on-track-to-submit-for-FDA-marketing-authorization. Published Aug. 31, 2022. Accessed Sept. 1, 2022.