Evofem Biosciences, Inc. recently issued the following announcement.
Evofem Biosciences, Inc. (NASDAQ: EVFM), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) acknowledged receipt of the New Drug Application (NDA) resubmission for Amphora®, a Multipurpose Vaginal pH Regulator (MVP-R™), for the prevention of pregnancy. Deemed a Class 2 resubmission by the FDA, the agency has assigned a six-month review period and a Prescription Drug User Fee Act (PDUFA) goal date of May 25, 2020.
"Today's acknowledgement brings us one step closer to delivering the first true contraceptive innovation in decades," said Saundra Pelletier, Evofem Biosciences' Chief Executive Officer. "We look forward to continuing to work closely with the FDA during the review process and to the potential to offer women a new, non-hormonal prescription contraceptive option that puts them in control of their sexual health."
The Amphora NDA resubmission includes full results from the Phase 3 AMPOWER study, a confirmatory single-arm, open-label Phase 3 trial that evaluated the efficacy and safety of Amphora in approximately 1,400 healthy women ages 18 to 35 years.
The Company is also evaluating the potential use of Amphora for the prevention of urogenital chlamydia and gonorrhea in women. Top-line results from the Phase 2b AMPREVENCE trial, reported in December 2019, demonstrated that the study met both its primary and secondary endpoints, with a 50% relative risk reduction in chlamydia infection and a 78% relative risk reduction in gonorrhea infection compared to placebo.
About Amphora
Amphora® (L-lactic acid, citric acid and potassium bitartrate) is an investigational Multipurpose Vaginal pH Regulator (MVP-R™) designed to regulate vaginal pH within the normal range of 3.5 to 4.5, even in the presence of semen, which normally raises the vaginal pH to 7.0 to 8.0. This maintains an acidic environment that 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.
About Evofem Biosciences
Evofem Biosciences, Inc., (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 Biosciences 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 lead Multipurpose Vaginal pH Regulator (MVP-R™) product candidate, Amphora®, is in development for multiple potential indications: prevention of pregnancy, prevention of urogenital transmission of Chlamydia trachomatis infection (chlamydia) in women, and prevention of urogenital transmission of Neisseria gonorrhoeae infection (gonorrhea) in women. For more information regarding Evofem, please visit www.evofem.com.
Amphora® is a registered trademark and MVP-R™ is a trademark of Evofem Biosciences, Inc.
Original source can be found here.
