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(Alliance News) - Futura Medical PLC on Thursday said it is pursuing the medical device regulatory pathway for its erectile dysfunction treatment MED3000.
The pharmaceutical company said MED3000 is a gel that utilises its DermaSys drug delivery technology to "stimulates nerve sensors in the highly-innervated glans penis rapidly, leading to smooth muscle relaxation, tumescence and erection."
DermaSys is a proprietary patented transdermal technology platform designed to deliver pharmaceutical treatments via the skin. "The clear, odourless gel provides local topical application to the required site of action".
Futura said that clinical data from the Phase 3 study showed MED3000 to be an "extremely effective and safe treatment" for erectile dysfunction. The company said patients experienced a fast onset of action with the product beginning to work immediately in some, and with over 60% of patients results within 10 minutes of application. The company added that the adverse events recorded were substantially lower than seen with oral treatments.
The company is therefore pursuing EU medical device regulatory pathway for DermaSys and has commenced the process to secure EU consent for MED3000.
Futura said that it commenced formal proceedings on Wednesday for MED3000 to be approved as a medical device. The proceedings will allow the it to submit its technical file for review including the full clinical study report for its Phase 3 study and the its quality management system in mid-2020.
The Gulidford-based company also said it has scheduled a meeting with the US Food & Drug Administration due to take place in the first quarter of 2020. The meeting is expected to provide the regulatory body's opinion on the requirements for regulatory filing for MED3000 within the US.
Futura said it continues to target mid-2020 for regulatory submissions in the US and the EU.
"We are encouraged by our initial interactions with the regulators which endorse our early advice and belief that MED3000 will be approved as a medical device with strong clinically-proven claims," said Chief Executive James Barder.
The stock closed 9.8% up at 11.75 pence each on Thursday in London.
By Ife Taiwo; ifetaiwo@alliancenews.com
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