Evofem: Phase 3 AMPOWER Trial Meets Primary Endpoint - Quick Facts

(RTTNews) - Evofem Biosciences, Inc. (EVFM) announced that its Phase 3 clinical trial of Amphora for the prevention of pregnancy, AMPOWER, successfully met its primary endpoint. AMPOWER assessed the efficacy, safety and subject satisfaction with Amphora in approximately 1,400 healthy women. Top-line data from the trial demonstrated an 86.0% efficacy rate, which meets the pre-determined endpoint of the clinical trial. The company said this positive outcome supports the potential of Amphora, Evofem's Multipurpose Vaginal pH Regulator, to become the first non- hormonal, on-demand, woman-controlled prescription birth control vaginal gel.

Saundra Pelletier, CEO of Evofem Biosciences, said: "We look forward to further data analysis and to submitting the Amphora NDA to the FDA in the second quarter of 2019. If approved, we plan to commercialize this first- in-class MVP-R for birth control in January 2020 to meet the needs of the 16.5 million women who are not using a contraceptive method but do not want to get pregnant, including women who cannot or will not use hormonal birth control methods."

Amphora is designed to regulate vaginal pH within the normal range of 3.5 to 4.5. This maintains an acidic environment, which is inhospitable to sperm as well as certain viral and bacterial pathogens associated with sexually transmitted infections.