Source- Futura Medical
The first business in the US to provide a topical erectile dysfunction medication to the market without a prescription is Futura Medical.
According to CEO James Barder, the FDA’s approval of the medication known as Eroxon (formerly MED3000) for over-the-counter sale through the “de novo” medical device pathway is a “huge milestone” for the business.
“The FDA set a very high standard in evaluating the effectiveness and safety of de novo medical devices,” he said. “I am delighted that we met this standard with MED3000’s submission.”
Currently, oral PDE5 inhibitor medicines, like Viagra (sildenafil) and Cialis (tadalafil) from Pfizer and Eli Lilly, or their generic counterparts, are the major treatments used to treat ED in the US. However, these medications are only available with a prescription.
The US commercialization efforts of UK-based Futura for Eroxon will be supported in part by a new £4.4 million ($5.5 million) fundraising round, according to the company’s announcement. The product was launched in the UK and Belgium in March after receiving EU and UK approval as a medical device.
According to Futura, Eroxon works in around 10 minutes and comes in the shape of a topical gel with an evaporative mode of action that stimulates nerve endings to induce an erection.
Its original medication, MED2005, which had glyceryl trinitrate as an active component, was developed clinically using this formulation as the control. Trial results revealed that the substitute functioned equally well, paving the path for Futura to pursue an OTC registration as opposed to a prescription medicine registration.
The primary FM71 trial, which was presented in favor of Eroxon, demonstrated that the topical gel formulation significantly improved erectile function after 24 weeks compared to baseline in patients with mild, moderate, and severe ED.
Despite the fact that oral tadalafil was more successful than the gel at treating ED symptoms, both treatments significantly reduced these symptoms 24 weeks after the research began.
Futura is hopeful that its non-systemic, over-the-counter alternative would be well-liked by patients because PDE5 inhibitors can have negative effects and are contraindicated with some medications. Given that one in five men worldwide are thought to have ED, Eroxon may potentially serve tens of millions of people in both the US and Europe.
It remains to be seen if it appeals to males, but Futura has previously stated that, depending on the pack price, sales may vary from hundreds of millions of dollars to almost $1 billion annually. For a pack of four single-dose tubes, the gel costs £24.99 in the UK, but Futura has not yet disclosed its price strategy for the US market.
