“Today’s submission represents a significant step forward for Evofem and for the millions of women who are dissatisfied with their current contraceptive options and are eagerly awaiting a new alternative,” said Saundra Pelletier, Evofem Biosciences’ Chief Executive Officer. “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.
According to the FDA’s classification, this application will be considered a Class 2 resubmission. Under the Prescription Drug User Fee Act (PDUFA), FDA review of a Class 2 resubmission is expected to be completed within a six-month period beginning on the date the resubmission is received.
Source: Company Press Release