The Futura Medical PLC (LON: FUM) share price surged 34.8% after revealing that the US Food and Drug Administration (FDA) had finally granted over-the-counter sale (OTC) Marketing Authorisation for MED3000, its breakthrough topical gel for treating erectile dysfunction (ED).
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The company noted that it could now legally market MED3000 in the United States as the first topical treatment for ED available over the counter without needing a prescription. The gel has a 10-minute onset of action and is a practical, clinically proven treatment for ED.
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Unlike other ED drugs such as Viagra and Cialis, which are oral medications (PDE5i’s) that require a doctor’s prescription in the USA, MED3000 does not require such. Viagra and Cialis also must be taken at least 30 minutes in advance, unlike MED3000’s 10-minute onset window.
ED affects at least 1 in 5 men globally, with about 22 million men in the USA suffering from the condition, making the country the largest ED market in the world. MED3000 has also been approved as the first pan-European clinically proven topical treatment for ED available OTC and is now available in Belgium and the UK.
The drug has been marketed under the Eroxon® brand name and was first launched in March 2023. The company plans more launches in 2023 and beyond, having signed commercial agreements in critical markets such as the European Economic Area.
James Barder, Futura Medical’s CEO, said: “The granting of marketing authorisation by the US FDA as the first clinically proven, topical gel for the treatment of ED in the USA available without a doctor's prescription is a huge milestone for Futura and highlights the incredible progress that the Company continues to make. FDA set a very high standard in evaluating the effectiveness and safety of De Novo Medical Devices.”
“I am delighted that we met this standard with MED3000's submission of 22 clinical, biocompatibility, human factors studies and performance bench tests, which were rigorously reviewed and accepted by the FDA. 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.”
*This is not investment advice.
Futura Medical share price.
The Futura Medical (FUM) shares were up 34.82% to trade at 57.30p, from Friday’s closing price of 42.50p.
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