Evofem Announces Completion of Last Subject Last Visit (LSLV) in Registrational Phase 3 "EVOGUARD" Trial Evaluating Phexxi® for the Prevention of Chlamydia and Gonorrhea in Women
-- Top-line readout of data expected in October 2022 --
-- U.S. regulatory submission planned for the first half of 2023 --
-- Phexxi may become the first-ever woman-controlled prophylactic for the prevention of chlamydia and gonorrhea --
SAN DIEGO, Aug. 1, 2022 /PRNewswire/ -- Evofem Biosciences, Inc., (Nasdaq: EVFM) today announced that the last subject has completed her last visit in EVOGUARD, the Company's registrational Phase 3 trial evaluating the efficacy and safety of Phexxi® (lactic acid, citric acid, potassium bitartrate) for the prevention of chlamydia and gonorrhea infection in women. There are no prescription pharmaceuticals approved to prevent these sexually transmitted infections (STIs).
Top-line data from EVOGUARD is expected in October 2022. Evofem expects positive outcomes would enable the Company to submit regulatory applications in the first half of 2023 to the U.S. Food and Drug Administration (FDA) to expand Phexxi's approved indications to include prevention of urogenital chlamydia and gonorrhea in women. Phexxi is currently approved in the U.S. for the prevention of pregnancy.
"This is a major milestone for Evofem and brings us closer to our goal of providing women a safe and effective, woman-controlled prophylactic measure against chlamydia and gonorrhea, the two most commonly reported sexually transmitted infections in the U.S.," said Saundra Pelletier, Chief Executive Officer of Evofem. "We believe these potential new indications represent significant upside for shareholders, above and beyond the multi-billion-dollar birth control market which we continue to increasingly penetrate with Phexxi for hormone-free contraception."
20% of people in the U.S. had an STI on any given day in 2018, according to a 2021 study in the journal Sexually Transmitted Diseases. The CDC estimates that 4.0 million and 1.6 million new cases of chlamydia and gonorrhea, respectively, occurred that year.1 Infected people are often unaware of, and do not seek treatment for their infections. Almost 60% of women infected with chlamydia have no symptoms.2
Chlamydia is the most frequently reported bacterial infection in the U.S. and can infect both men and women. It can cause serious, permanent damage to a woman's reproductive system and make it difficult or impossible for a woman to become pregnant later in life.
Chlamydia and gonorrhea have been reported to be responsible for one-third to half of pelvic inflammatory disease (PID) cases. PID can cause serious, long-term problems including infertility, ectopic pregnancy, and chronic pelvic pain.
EVOGUARD builds on the positive, statistically significant outcomes of AMPREVENCE, the randomized, double-blind placebo-controlled Phase 2b/3 study evaluating Phexxi for the prevention of chlamydia and gonorrhea. AMPREVENCE met its primary and secondary endpoints and showed that the product was generally safe and well-tolerated.
The FDA has granted Fast Track designation and "Qualified Infectious Disease Product" (QIDP) designation to Evofem's product candidate for the prevention of both chlamydia and gonorrhea in women.
The Fast Track program facilitates the expedited development and review of new drugs or biologics that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. The purpose is to get important new drugs to the patient earlier.
QIDP designation is intended to encourage development of new products for the treatment of serious or life-threatening infections. A drug or product in development that receives this designation qualifies for an additional five years of marketing exclusivity following FDA approval for that indication.
Evofem is grateful to the study investigators and coordinators at the more than 100 participating study centers across the U.S., as well as the 1,903 women who participated in this landmark study.
About Evofem Biosciences
Phexxi® is a registered trademark of Evofem Biosciences, Inc.
Important Safety Information
For more information about Phexxi, talk to your healthcare provider and see full Product Information at www.phexxi.com. Please report side effects by contacting Evofem Biosciences toll-free at 1-833-EVFMBIO or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Intended for United States residents only.
View original content to download multimedia:https://www.prnewswire.com/news-releases/evofem-announces-completion-of-last-subject-last-visit-lslv-in-registrational-phase-3-evoguard-trial-evaluating-phexxi-for-the-prevention-of-chlamydia-and-gonorrhea-in-women-301596733.html
SOURCE Evofem Biosciences, Inc.
Company Codes: NASDAQ-NMS:EVFM