Amphora refiled with FDA for the prevention of pregnancy- Evofem Biosciences

Evofem Biosciences announced that it has resubmitted its New Drug Application (NDA) to the FDA for Amphora (L-lactic acid, citric acid and potassium bitartrate), a Multipurpose Vaginal pH Regulator (MVP-R), for the prevention of pregnancy.

The Amphora NDA resubmission includes full results from the Phase III AMPOWER study, a confirmatory single-arm, open-label Phase III 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.

Overall in the AMPOWER study there were more than 24,000 acts of intercourse in which Amphora use was reported. Of these, Amphora was used as directed 88.9% of the time. There were minimal side effects reported by AMPOWER study participants, and there were no serious treatment-related adverse events reported.