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Evofem Biosciences, Inc. (NASDAQ: EVFM) is a commercial-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company aims to advance the lives of women by developing innovative solutions, such as woman-controlled contraception and potential protection from certain sexually transmitted infections (STIs).
The Company’s first commercial product, Phexxi™ (lactic acid, citric acid, and potassium bitartrate) vaginal gel, was approved by the U.S. Food and Drug Administration on May 22, 2020 for the prevention of pregnancy in women who choose to use on demand methods for their contraceptive needs. Phexxi is the only hormone-free, female-controlled, on-demand prescription contraceptive gel and the first contraceptive innovation in decades.
The New Drug Application for Phexxi was supported by data from the AMPOWER trial, a Phase 3 single-arm, open-label trial designed to assess the effectiveness of Phexxi in preventing pregnancy and its safety over 7 menstrual cycles of use in women who were using no other form of birth control. The study enrolled approximately 1,400 women at 115 study centers in the United States. The top-line data met the pre-specified primary endpoint of this trial, and Phexxi had a favorable safety profile and was well tolerated.
The Company is also pursuing developing of EVO100, a vaginal pH regulator being evaluated for prevention of urogenital transmission of both Chlamydia trachomatis infection (chlamydia) and Neisseria gonorrhoeae infection (gonorrhea) in women.
In December 2019, Evofem reported positive, statistically significant top-line data from a double-blind placebo-controlled Phase 2b clinical trial (AMPREVENCE) evaluating EVO100 to prevent urogenital acquisition of certain sexually transmitted infections in women. This landmark study met its primary and secondary endpoints, demonstrating a 50% relative risk reduction in chlamydia infection and a 78% relative risk reduction in gonorrhea infection compared to placebo.
The Company has assembled a very strong management team with significant operational experience in the biopharmaceutical market. Specifically, our senior executives have a successful track record of developing and commercializing women’s health products including Mirena, Plan B One-Step, Yasmin, YAZ, NuvaRing, Paragard and Seasonique, among others.