Key points:
- Futura Medical (FUM) shares rallied 9.88% on a key milestone for MED3000.
- The company has completed all the work required for the FDA’s approval.
- The question remains. Will the FDA approve MED3000 as an OTC drug?
The Futura Medical plc. (LON: FUM) share price rallied 9.88% after announcing that it had completed all the work required to apply for marketing authorisation for MED3000, its erectile dysfunction treatment within the United States.
The company noted that it had finalised all the prerequisites for its De Novo Medical Device Application and would be submitting the folder to the US Food and Drug Administration (FDA) for marketing authorisation, which it expects to receive by the end of Q1 2023.
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Futura Medical noted that it had met all the requirements set by the FDA following five pre-submission meetings with the FDA and the completion of two phases 3 clinical trials testing MED3000’s ability to treat mild, moderate and severe erectile dysfunction.
The company recently announced the results from a pivotal phase 3 clinical trial mandated by the FDA, which met all its primary and secondary endpoints. The results showed that MED3000 is an effective clinically-proven treatment for ED. The company is seeking authorisation for over-the-counter sales of the topical gel.
Erectile dysfunction is a rapidly-expanding disease affecting men of all ages, and MED3000 is one of the first clinically-proven treatments for the debilitating disease. Furthermore, the gel is proven to act fast and has a favourable risk profile, making it ideal for over-the-counter classification.
MED3000 was first given the CE Mark designation in April 2021 and is now sold throughout Europe, the UK, and other countries that accept the CE Mark designation. Since then, Futura Medical’s focus has been on the US market, given its size.
If approved by the FDA, MED3000 will be the first leading ED treatment available OTC across the USA. The gel will be marketed under the Eroxon brand.
James Barder, Futura Medical’s CEO, said: “Today marks a pivotal milestone for Futura and highlights the regulatory progress we have made to develop and launch MED3000 globally. 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.”
*This is not investment advice.
Futura Medical share price.
The Futura Medical share price rallied 9.88% to trade at 40.02p, rising from Friday’s closing price of 36.42p.