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Evofem (NASDAQ: EVFM) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health.
Evofem’s lead product candidate, Amphora®, is a Multipurpose Vaginal pH Regulator (MVP-R)TM designed to regulate vaginal pH to 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, but is integral to the survival of healthy bacteria in the vagina.
The Company resubmitted the Amphora New Drug Application (NDA) in November 2019 based on the positive results of AMPOWER, a pivotal Phase 3 clinical trial of Amphora for prevention of pregnancy. An FDA decision on this NDA is expected in May 2020 based on a six-month review.
Evofem plans to commercialize Amphora in 2020 as the first and only hormone-free, female-controlled, on-demand prescription contraceptive (assuming approval).
The Company reported top-line data in December 2019 from a double-blinded placebo-controlled Phase 2b clinical trial (AMPREVENCE) evaluating Amphora to prevent urogenital acquisition of Chlamydia trachomatis (primary endpoint) and Neisseria gonorrhea (secondary endpoint) in women. This clinical trial enrolled approximately 850 women at approximately 50 centers in the United States for a four-month interventional period and subsequent one-month follow-up period.
The CDC reported in October 2019 that rates of gonorrhea and chlamydia climbed for the fifth consecutive year in the United States. Nearly 1.8 million U.S. cases of chlamydia were diagnosed in 2018, a 19% rate increase over the prior year.1
Evofem’s second product candidate is a MVP-RTM to reduce the recurrence of bacterial vaginosis (BV), which is caused by an imbalance of a woman’s vaginal bacteria, leading to unpleasant odor and abnormal vaginal discharge. The Company recently completed a Phase 1 trial, and is currently designing a Phase 2b trial for this indication.
1Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2018. Atlanta: U.S. Department of Health and Human Services; 2019. DOI: 10.15620/cdc.79370.