FDA grants OTC marketing clearance to topical gel for erectile dysfunction

The FDA has granted over the counter (OTC) Marketing Authorization to the topical gel formulation MED3000 (trade name, Eroxon) for the treatment of erectile dysfunction.¹

Clinical support for MED3000 came from two phase 3 clinical trials conducted by Futura, known as FM57 and FM71.

The approval was announced in a press release from Futura Medical, the pharmaceutical company that manufactures the gel. According to the company, MED3000 has a quick 10-minute turnaround time from application to the “onset of action.”¹ The company explained in the press release that this turnaround time compares favorably with the ≥30-minute turnaround time of PDE5 inhibitors (Cialis and Viagra), which are oral medications commonly used to treat individuals with erectile dysfunction. The company additionally noted that PDE5 inhibitors are not approved for OTC marketing in the United States.

“The granting of marketing authorisation by the FDA as the first clinically proven, topical gel for the treatment of erectile dysfunction in the United States available without a doctor’s prescription is a huge milestone for Futura and highlights the incredible progress that the company continues to make,” James Barder, chief executive officer of Futura Medical, the manufacturer of MED3000, stated in the press release.¹

“The FDA set a very high standard in evaluating the effectiveness and safety of De Novo Medical Devices. 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 FDA approval is a major de-risking event for the Company and we look forward to updating shareholders on our US commercialization plans in due course,” added Barder.¹

Clinical support for MED3000 came from two phase 3 clinical trials conducted by Futura, known as FM57 and FM71. In FM71, specifically, the efficacy and safety of MED300 were assessed in 96 male patients with erectile dysfunction classified as mild, moderate, or severe.² The origin of patients’ erectile dysfunction was organic, psychological, or both. Patients were treated at clinical sites in the United States, Poland, Georgia, and Bulgaria. Highlights from FM71 included:

• Compared with baseline, scores on the International Index of Erectile Function (IIEF-EF) at 24 weeks showed a statistically significant improvement in erectile function in a pooled population of patients with erectile dysfunction ranging from mild to severe.
• At 24-weeks, there was a 5.73 unit change in IIEF-EF scores compared with baseline.2 This surpassed the Minimal Clinical Important Difference of 4 units that was collaboratively established with the FDA.²
• A time of 10 minutes was demonstrated to be the interval from the time of application to the time of the gel taking effect.²
• MED3000 was determined to be tolerable and safe. No serious adverse events were observed by the study investigators.

MED3000 was previously approved in the European Union for the treatment of patients with erectile dysfunction.

References

1. Futura Medical. US FDA Grants for Over-the-Counter Marketing Authorization to Futura for Fast-Acting Topical Gel, MED3000, to Treat Erectile Dysfunction. Published accessed June 12, 2023. Accessed June 16, 2023. https://tinyurl.com/5h5b8cyf

2. Futural Medical. MED3000 clinical Programme. Accessed June 16, 2023. https://tinyurl.com/cmw8phjb