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Positive Study Results Put Futura’s OTC Erectile Dysfunction Gel On Track For 2023 US Launch

 
• By David Ridley

Positive results from a confirmatory Phase III clinical study puts Futura Medical on track to file a dossier for drug-free erectile dysfunction gel MED3000 with the US Food and Drug Administration by the end of September 2022. This is in line with the company's timeline of approval as an OTC de novo medical device in Q1 2023.

US erectile dysfunction (ED) sufferers are one step closer to getting their hands on a drug-free OTC treatment after Futura Medical plc’s innovative MED3000 gel jumped another hurdle in the regulatory process.

Thanks to positive results from a confirmatory Phase III clinical study, FM71, which investigated the efficacy and safety of MED3000 gel in 96 male patients clinically diagnosed with a mix of mild, moderate, and severe ED, Futura is on track to file its dossier with the US Food and Drug Administration by

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