Topical gel for erectile dysfunction exhibits promise in part 3 trial

September 01, 2022

3 min learn


Key takeaways

  • In a confirmatory research, MED3000 was related to important enhancements in erectile dysfunction.
  • Researchers discovered that the gel helped folks attain an erection extra shortly when put next with tadalafil.
  • In mild of the outcomes, the producer stated it’s getting ready to submit an software to the FDA for advertising and marketing authorization.

An investigational remedy for erectile dysfunction met its main and secondary endpoints in a confirmatory part 3 medical research, demonstrating important enhancements at 24 weeks, in line with a press launch from the producer.

The remedy — MED3000 — is a topically-applied gel developed by Futura Medical. In keeping with the corporate, the gel is on monitor to develop into the primary main over-the-counter remedy for erectile dysfunction in the US.

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Erectile dysfunction impacts roughly 30 million males within the U.S., in line with the CDC. James Barder, CEO of Futura Medical, stated within the launch that he’s “excited on the prospect of bringing a really differentiated remedy possibility for males within the USA with [erectile dysfunction] with out the necessity for a health care provider’s prescription.”

“Within the USA, all clinically confirmed oral [erectile dysfunction] therapies are prescription-only and due to this fact MED3000 has the potential to be a major innovation with its key differentiator of a fast pace of onset and by creating a serious new OTC class for [erectile dysfunction] remedy,” Barder stated within the launch.

The research, often called FM71, included 96 males with erectile dysfunction who have been randomly assigned to obtain MED3000 or oral tadalafil tablets over 24 weeks, in line with the discharge.

Researchers discovered that MED3000 was related to a “extremely statistically important enchancment” in erectile perform from baseline to 24 weeks, as measured by the Worldwide Index of Erectile Perform-Erectile Perform (IIEF-EF). This was a main endpoint predetermined with the FDA.

Researchers additionally discovered that the gel helped sufferers get an erection shortly, a secondary endpoint of the trial. The information, in line with the producer, revealed a statistically important enchancment at 10 minutes, which was superior to the oral tadalafil tablets. Sometimes, these take between half an hour to an hour to work, in line with the discharge.

By way of exploratory endpoints, on the 24th week, 85.4% of these utilizing MED3000 reported that intercourse may very well be spontaneous, “reaffirming the fast onset of motion and key consumer profit,” the discharge stated.

The producer additionally famous that 19.1% of people that use tadalafil report complications, however solely 4.3% of MED3000 customers stated the identical. There was just one incident of gentle, native burning, and no severe hostile occasions, in line with the discharge.

“Information exhibits that MED3000 is efficient throughout all [erectile dysfunction] affected person severities and achieves clinically necessary efficacy at every time level as much as and together with 24 weeks. Notably, MED3000 helps males obtain first indicators of an erection inside 10 minutes, in line with predetermined statistical standards agreed to with the FDA,” Ken James, Futura Medical government director and head of analysis and growth, stated within the launch. “MED3000 has additionally demonstrated wonderful security compared with prescription oral remedy, and as such, has a really favorable profit to threat profile making it ideally suited to OTC classification all through the USA.”

In mild of the information, the Futura Medical stated it’s now “getting ready for an FDA regulatory submission close to the top of September,” and hopes that MED3000 turns into “the primary clinically confirmed ED product that’s accredited OTC in Europe and the U.S.”

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