Evofem resubmits NDA to FDA for Amphora
Evofem Biosciences announced that it has resubmitted its New Drug Application, or NDA, to the FDA for Amphora, a Multipurpose Vaginal pH Regulator, or MVP-R, for the prevention of pregnancy. The company said, "We have submitted a comprehensive and compelling package that we believe addresses the Agency's outstanding questions, and we look forward to the potential opportunity to provide millions of women with an innovative new hormone-free, on-demand, prescription contraceptive option that gives them control over their sexual and reproductive health." The Amphora NDA resubmission includes full results from the Phase 3 AMPOWER study, a confirmatory single-arm, open-label Phase 3 trial evaluating the safety and efficacy of Amphora in approximately 1,400 healthy women aged 18-35 years. The trial was designed with guidance and input from the FDA to address questions raised in the Complete Response Letter received by Evofem in April 2016.