The Food and Drug Administration (FDA) has granted marketing authorization to Futura Medical for the over-the-counter (OTC) sale of MED3000, a topical treatment for erectile dysfunction (ED).

According to the Company, the gel formulation is applied to the penis just before sex and has an onset of action of 10 minutes. The drug-free product produces a rapid cooling effect followed by a warming effect. This stimulates the nerve endings on the head of the penis, which then leads to vasodilation and erection.

The topical therapy has been shown to be safe and effective in two phase 3 clinical trials. In the FM71 study ( Identifier: NCT04984993), MED3000 gel was compared with oral tadalafil 5mg in 96 male patients clinically diagnosed with a mix of mild, moderate, and severe ED.

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Results showed that at 24 weeks, MED3000 gel demonstrated a statistically significant improvement in erectile function compared with baseline (as measured by the International Index of Erectile Function-Erectile Function score) and led to a clinically meaningful difference in improvement of erections (as defined in scientific papers by Rosen et al).

Onset of action was measured as a secondary endpoint. In the study, topical MED3000 demonstrated a 10-minute onset of action, which was faster than oral tadalafil 5mg. No serious adverse events were reported with the gel.

“The granting of marketing authorization by the US FDA as the first clinically proven, topical gel for the treatment of ED in the USA available without a doctor’s prescription is a huge milestone for Futura and highlights the incredible progress that the Company continues to make,” said James Barder, CEO of Futura Medical.  “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 topical gel will be available without a prescription under the brand name Eroxon®. The Company is currently in the process of securing a partner to launch the product in the US.

This article originally appeared on MPR