SAN DIEGO, CA —Evofem, Inc., a biotechnology company focused on the discovery and development of women’s health products, announced today that it concluded its pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding Amphora.
“We are encouraged and confident that we have received appropriate guidance as we prepare for the NDA submission of Amphora,” said Saundra Pelletier, CEO of Evofem, Inc. “This is an important first step in the lifecycle management of Amphora.”
The meeting was held on December 9, 2014 and meeting minutes have been received. The outcome of the pre-NDA meeting allows Evofem, Inc. to maintain expectations of an NDA filing for Amphora in mid-to-late 2015, as planned.
Amphora, a non-hormonal vaginal gel, recently completed a large, multicenter, open-label, randomized, phase III trial that examined the repeated use of Amphora gel compared to Conceptrol® Vaginal Gel as the primary method of contraception over seven cycles of use. The primary endpoint was rate of pregnancy.
About Evofem, Inc.
Evofem, Inc. is a privately held biotechnology company that discovers, develops and commercializes prescription and over-the-counter products in the areas of feminine care, contraception, and the prevention of sexually transmitted infections. Evofem, Inc. is committed to delivering effective, woman-controlled, rapidly reversible forms of contraception to women globally.