FDA grants OTC authorization to topical gel for erectile dysfunction

Key takeaways:

• MED3000 previously showed significant improvement in erectile function in a phase 3 trial.
• It is the first topical erectile dysfunction treatment that is available over the counter in the United States.

The FDA has granted over-the-counter authorization to Futura Medical for its topically applied gel treatment for erectile dysfunction as a de novo medical device, the company announced in a press release.

The treatment, Eroxon (MED3000), can now be marketed as the first topical gel treatment for erectile dysfunction to be available without a prescription in the United States, according to Futura Medical.

Erectile dysfunction affects about 30 million men in the U.S., according to the National Institute of Diabetes and Digestive and Kidney Diseases. Despite this, there has been “little innovation” over the last decade regarding erectile dysfunction medications, leaving many patients with “limited access to safe and effective treatments,” Futura Medical said.

“FDA set a very high standard in evaluating the effectiveness and safety of de novo medical devices,” Futura Medical CEO James Barder said in the release. “I am delighted that we met this standard with MED3000’s submission of 22 clinical, biocompatibility, human factors studies and performance bench tests which were rigorously reviewed and accepted by the FDA.”

The treatment’s effectiveness was previously demonstrated in a phase 3 study that included 96 men with erectile dysfunction who received either MED3000 or oral tadalafil tablets.

The researchers found that MED3000 was associated with a statistically significant improvement in erectile function from baseline to 24 weeks, the primary endpoint of the trial. The gel also improved the time it took patients to get an erection — 10 minutes vs. 30 to 60 minutes with oral tadalafil tablets — and was linked to a lower prevalence of headaches. No serious adverse events were reported.

MED3000’s favorable benefit vs. risk profile and rapid speed of onset made it suitable for OTC designation, according to the company.

“The FDA approval is a major de-risking event for the company, and we look forward to updating shareholders on our U.S. commercialization plans in due course,” Barder said.

References:

• Definition & facts for erectile dysfunction. https://www.niddk.nih.gov/health-information/urologic-diseases/erectile-dysfunction/definition-facts. Accessed June 13, 2023.
• 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, 2023. Accessed June 13, 2023.
• US FDA grants for over-the-counter marketing authorization to Futura for fast-acting topical gel, MED3000, to treat erectile dysfunction. https://www.businesswire.com/news/home/20230612591732/en/US-FDA-Grants-for-Over-the-Counter-Marketing-Authorization-to-Futura-for-Fast-Acting-Topical-Gel-MED3000-to-Treat-Erectile-Dysfunction. Published June 12, 2023. Accessed June 13, 2023.