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ARTICLE | Clinical News

Evofem to resubmit NDA for hormone-free contraceptive

January 11, 2019 6:01 PM UTC

Evofem Biosciences Inc. (NASDAQ:EVFM) said on Dec. 17 that it plans to resubmit an NDA to FDA next quarter for Amphora as a non-hormonal, on-demand, woman-controlled prescription birth control vaginal gel after the product met the primary endpoint in the single-arm, confirmatory Phase III AMPOWER trial. Amphora is a multipurpose Vaginal pH Regulator (MVP-R) comprising L-lactic acid, citric acid and potassium bitartrate.

In April 2016, FDA issued a complete response letter to an NDA for Amphora, citing differences in results between U.S. and Russian cohorts in the Phase III AMP001 trial to prevent pregnancy, despite meeting its primary endpoint. Evofem began AMPOWER following an October 2016 Type A meeting with FDA in which the agency indicated a single-arm, confirmatory efficacy trial would be sufficient to address the CRL...

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