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(Sharecast News) - Futura Medical has completed the work required for the FDA to grant marketing authorisation for 'MED3000', its fast acting clinically proven treatment for erectile dysfunction, it announced on Monday.
The AIM-traded firm said the dossier would now be submitted to the US Food and Drug Administration (FDA), adding that it remained "confident" of being granted marketing authorisation by the end of the first quarter of 2023. in line with its previously-announced timelines.
It followed the April 2021 CE-mark approval of MED3000 as the first clinically proven, pan-European topical treatment for adult men with ED, available without a doctor's prescription.
The FDA submission closely followed FDA guidance on De Novo applications, as well as guidance received from the FDA in five pre-submission meetings.
That included a human factors study supporting over-the-counter (OTC) designation, and two phase 3 clinical studies with MED3000 for the treatment of mild, moderate and severe ED.
Those studies were the FM57 clinical trial used for approval in Europe, and the recently-announced results from the FDA-agreed pivotal phase 3 clinical study, FM71, which successfully met all primary and secondary endpoints.
The board said the results demonstrated that MED3000 presented an effective clinically-proven treatment for ED with a rapid speed of onset, and a favourable benefit versus risk profile ideally suited for OTC classification in the US.
Subject to FDA granting marketing authorisation, MED3000 would become the first major ED treatment available OTC throughout the United States.
Futura said it was continuing to strengthen its network of licensing and distribution partners across the globe, and recently announced that its search for US commercial partners had started following the successful completion of FM71, and the completion of the FDA submission, representing a "major" value inflection point.
"Today marks a pivotal milestone for Futura and highlights the regulatory progress we have made to develop and launch MED3000 globally," said chief executive officer James Barder.
"The submission of our marketing application in the US will pave the way for commercialisation of MED3000 in the biggest ED market worldwide with our key differentiator of a clinically proven treatment for ED with a rapid speed of onset."
Barder said MED3000 was also expected to be the first major ED treatment available OTC in the US, which the company believed would help improve access as well as treatment for "many thousands" of ED sufferers.
"We believe Eroxon, the brand for MED3000, is poised to become a major, trusted brand and treatment in the ED market worldwide."
At 1251 BST, shares in Futura Medical were up 3.51% at 38.3p.
Reporting by Josh White at Sharecast.com.
