The Futura Medical plc. (LON: FUM) share price rose 5.36% after releasing an update about its MED3000 topical gel formulation for treating erectile dysfunction (ED) in men. The drug has been approved as an over-the-counter (OTC) ED treatment in multiple jurisdictions.
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MED3000 first gained regulatory approval in the European Union, where it was awarded the CE mark in 2021. The drug also gained regulatory approval in the UK by obtaining the UKCA mark as a Class 2A medical device in April 2022.
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Futura Medical noted that it had begun manufacturing MED3000 for sale in the EU and the Middle East under the Eroxon® brand name. The company received its first commercial order for the drug in September 2022 and is currently manufacturing the first batch.
Eroxon® will be distributed in the EU and UK by Futura’s distribution partner Cooper Consumer Health, which made the first order in September. Cooper Health plans to launch the drug in the target markets soon.
The drug’s launch in the Middle East is expected in 2023 after Futura Medical signed a distribution agreement with Labatec Pharma after the drug gained regulatory approval in several countries, including the UAE.
Futura also has commercial agreements with distribution partners in countries such as Switzerland, the Gulf Co-operation Council (GCC) region and South Korea. However, investors were interested in the drug’s progress in the highly lucrative US market.
The company noted that it had completed the additional Phase 3 clinical study, known as “FM71” for MED3000, requested by the US FDA, which was designed to provide 24-week efficacy and safety data.
The study commenced in September 2021, with the results being released in August 2022. The results showed that the study met its primary and secondary endpoints. The company then filed for Marketing Authorization of MED3000 as a De Novo Medical Device in October 2022.
The FDA recently informed Futura Medical that its application was officially under review and had passed the initial technical screening. The firm expects the FDA to approve MED3000 by the end of Q1 2023.
I expected a better reaction from investors, but the small rally was still welcome. FUM shares are up 22.8% this year and could rally higher.
*This is not investment advice.
Futura Medical share price.
The Futura Medical share price rose 5.36% to trade at 50.55p, rising from Monday’s closing price of 47.98p.
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