FDA OKs Over-the-Counter Gel for Erectile Dysfunction

The FDA has granted over-the-counter marketing authorization to MED3000 (Eroxon), the first nonprescription topical gel for treating erectile dysfunction (ED) in men age 22 and older, maker Futura Medical announced on Monday.

According to the company, MED3000 has "a 10-minute onset of action" that sets it apart from prescription PDE5 inhibitors such as sildenafil (Viagra) and tadalafil (Cialis), which typically require a longer period of time to take effect.

The non-medicated hydro-alcoholic gel was initially tested as the placebo comparator in studies of a nitroglycerin gel the company was developing, but in a large phase III trial it turned out MED3000 worked just as well.

"FDA set a very high standard in evaluating the effectiveness and safety," James Barder, Chief Executive Officer of Futura Medical, said in a statement. "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."

Last August, the company announced positive results from FM71, a confirmatory 24-week multicenter phase III trial that compared MED3000 to oral tadalafil in 96 ED patients.

Both primary endpoints were achieved in the open-label study. At 24 weeks, scores on the International Index of Erectile Function – Erectile Function (IIEF-EF) scale were significantly improved across mild, moderate, and severe ED (P<0.001), with a demonstrated durability of response beyond 12 weeks. And patients assigned to the gel experienced an average 5.73-unit change from baseline in IIEF-EF score at 24 weeks, exceeding the 4-unit difference required by the FDA and defined as the minimal clinically important difference.

MED3000 also met FDA criteria for rapid onset, a secondary endpoint of the trial, with a significant improvement in erectile function at 10 minutes; tadalafil did not meet the criteria at that time.

In its announcement of the marketing authorization, the FDA noted that the volatile components of the product -- alcohol and water -- "evaporate to create a rapid, localized cooling effect on the glans penis followed by a recovering slower warming effect. This stimulates the nerve endings leading to tumescence and erection."

In the FM71 trial, headache was reported in 19% of those randomized to tadalafil versus 4% of those assigned to the topical gel, while noncardiac chest pain and back pain were only reported in the PDE5 inhibitor group (4% for each). Nausea was reported in 4% of those using MED3000, along with one instance of "mild local burning," the company said. No local side effects were reported among sexual partners.

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