SAN DIEGO – Evofem, a biotechnology company focused on the development and commercialization of women’s health products, announced today that it met with representatives of the U.S. Food and Drug Administration (“FDA”) in a Pre-IND (Investigational New Drug) meeting for its lead product, Amphora to be evaluated for the prevention of recurrence of Bacterial Vaginosis (BV). Research suggests Amphora, a vaginally delivered topical gel, works through a novel mechanism of action against several bacterial and viral organisms. As a result of this meeting, Evofem will be developing a formal research protocol to begin clinical studies.
Saundra Pelletier, Chief Executive Officer of Evofem, said, “I am pleased with the guidance we received and the clarification of the work necessary to file an Investigational New Drug Application. This area of development is consistent with our platform of finding and developing promising healthcare solutions that address unmet needs for women worldwide.”
A New Drug Application for Amphora as a non-hormonal, vaginal gel contraceptive was accepted by the United States Food and Drug Administration (FDA) in July of 2015.
Evofem Holdings, Inc. seeks to address a growing global contraceptive market, while delivering effective, woman-controlled products with global distribution. Evofem Holdings, Inc. has two lead product candidates: Amphora, a non-hormonal contraceptive gel, and the Nestorone Ring, a one-year contraceptive vaginal ring, both of which have completed Phase III clinical studies.
For further information on the Company, please visit: www.evofem.com
Amphora is a non-hormonal vaginal gel. In addition to the regulatory filing for approval as a contraceptive, Amphora is being investigated for microbicidal properties to develop a potential multipurpose prevention technology. Amphora works by restoring the vaginal pH levels to those consistent with a healthy vaginal environment.
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