Shares in Futura Medical PLC (AIM:FUM, OTC:FAMDF) jumped by 22% in the first half-hour of trading following the news that its topical erectile dysfunction (ED) gel, MED3000, received over-the-counter (OTC) marketing approval from the US Food and Drug Administration (FDA).
This is the first time the FDA has given such an approval for a topical ED solution.
The product, which shows results in just 10 minutes, presents a competitive alternative to prescription-based medications like Cialis and Viagra, which usually take 30 minutes to work and can cause side effects.
The regulatory green light allows Futura to tap into the US market, where over 22 million men suffer from ED.
MED3000 is already available OTC in Europe, including the UK and Belgium. Futura's CEO, James Barder, hailed the FDA's endorsement as a "huge milestone" and promised updates on the company's US commercialisation strategy.
In early trade, the stock was up 9.3p at 52.2p. This values the business at just shy of £150mln.