20th Apr 2020 13:24
(Alliance News) - Futura Medical PLC on Monday said it has filed for a further pre-submission meeting in the US to discus its topical erectile dysfunction treatment MED3000 following a phase 3 study.
Shares in Futura were up 10% at 11.32 pence in London in afternoon trading.
MED3000 is Futura's lead product. In the phase 3 FM57 study of 1,000 patients, Futura said, MED3000 was found to have potential as a topical treatment "with a fast onset of action and excellent safety profile". Since then, the company has also received the complete and signed FM57 clinical study report.
In April 2020, the US Food & Drug Administration agreed to a de novo medical device application for MED3000, though this was subject to another pre-submission meeting to talk over the full clinical study report as well as supporting information. The de novo regulatory pathway is used when a product is considered "novel" by the FDA, with no similar product already on the market.
Should the FDA meeting go well, Futura said it could file its submission for pre-marketing clearance review in the third quarter of 2020.
Chief Executive James Barder said: "Following extensive review of the clinical data, we are pleased to have received the completed and signed [clinical study report] for FM57, and have filed the necessary data in order for the company to have the next pre-submission meeting to further discuss clinical sufficiency and/or post-marketing requirements for MED3000. As a breakthrough treatment for erectile dysfunction, we are confident that we will receive MED3000 approval as a medical device, and we continue to target the next six months for regulatory submissions in both Europe and USA."
By Anna Farley; [email protected]
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