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Evofem Plans 2019 Refiling For Amphora Based On New 86% Contraception Efficacy

 
• By Joseph Haas

Evofem intends to refile the NDA for its non-hormonal contraceptive Amphora during the second quarter of 2019, after the Phase III AMPOWER study showed 86% efficacy for typical use and 98.7% efficacy when the gel was used as directed.

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Evofem Biosciences Inc. believes it can offer a new contraception alternative to women that will avoid the side effects and risks of hormonal products and offer on-demand use as a vaginal gel based on Phase III data for Amphora that show 86% efficacy in preventing pregnancy during typical use and 98.7% efficacy when users applied the product as directed. While the latter number is more impressive, the former will be the basis for the labeling claim Evofem will seek from the US FDA.

The San Diego-based women’s health company reported top-line data Dec. 17 for Amphora showing that it met the primary endpoint...

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