(Alliance News) - Futura Medical PLC said on Monday that the US Food & Drug Administration granted over the counter sale marketing authorising for MED3000, the company's treatment of erectile dysfunction.
Shares in the Guildford, Surrey pharmaceutical company focussing on sexual health products jumped by 19% to 51.00 pence each in London on Monday morning.
Futura said that the FDA had granted the erectile dysfunction formulation as a de novo medical device.
The de novo regulatory pathway is used when a product is considered "novel" by the FDA, with no similar product already on the market.
Futura Medical said that MED3000 is now legally marketed in the US as the first topical treatment for erectile dysfunction available over the counter without the need for a prescription.
MED3000 was made available online in Europe in March 2023 under the name Erexon, with Futura stating that more launches are planned in the year in key markets including Switzerland, South Korea, Latin America, and the Middle East.
Chief Executive Officer James Barder said: "The granting of marketing authorisation by the US FDA as the first clinically proven, topical gel treatment of erectile dysfunction in the US available without a doctor's prescription is a huge milestone for Futura and highlights the incredible progress that the company continues to make."
"The FDA approval is a major de-risking event for the company and we look forward to updating shareholders on our US commercialisation plans in due course."
By Will Neill, Alliance News reporter
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Futura Medical (FUM)