SAN DIEGO—Evofem Biosciences Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Evofem’s Phexxi (lactic acid, citric acid and potassium bitartrate) vaginal gel for the prevention of pregnancy in females as an on-demand method of contraception. Phexxi is reportedly the first non-hormonal, on-demand, vaginal pH regulator contraceptive designed to maintain vaginal pH within the normal range of 3.5 to 4.5 – an acidic environment that is inhospitable to sperm.
Phexxi is designed to regulate vaginal pH within the normal range of 3.5 to 4.5 even in the presence of semen, which normally raises 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 — and integral to the survival of healthy bacteria in the vagina.
“There have been a limited number of advances in birth control over the last two decades; Phexxi represents an important step forward in women’s health,” said Michael A. Thomas, M.D., chair of the Department of Obstetrics and Gynecology at the University of Cincinnati College of Medicine. “Many of my patients have cycled through numerous contraceptive options and still have not found the right fit for their sexual and reproductive needs. Phexxi offers women freedom from hormones and control over how they choose to prevent pregnancy. I look forward to offering this new on-demand option to my patients.”
Evofem expects to launch Phexxi in early September, alongside the Phexxi Concierge Experience. The Phexxi Concierge Experience is a comprehensive patient and healthcare provider telemedicine support system designed to provide physicians with on-demand educational support, as well as speed and simplify women’s access to Phexxi. This service can be used to secure a prescription, determine insurance coverage and/or out-of-pocket costs, receive counseling support and refill reminders, and fill prescriptions through local pharmacies or an online pharmacy.
“The FDA approval of Phexxi means women now have access to a non-hormonal contraceptive option that they control, on their terms, to be used ONLY when they need it. Empowerment results from innovation and we are proud and excited to deliver new innovation to women in a category ready for change,” added Saundra Pelletier, chief executive officer of Evofem.
As the first vaginal pH regulator with a unique mechanism of action, Evofem is working to have Phexxi covered under the Affordable Care Act (ACA). The ACA mandates that private health plans provide coverage with no out-of-pocket costs for one treatment per class in each of the classes identified by the FDA in its birth control guide. Evofem says that the company is committed to ensuring access to Phexxi for all women seeking non-hormonal contraception — including women who are not covered by government or private health plans — and plans to provide a financial assistance program to enable access for eligible women.
“During my 15-year career at the FDA, I participated in the review and approval of many sexual and reproductive health products, and I believe that Phexxi serves a true unmet need in contraception,” noted Lisa Rarick, M.D., former FDA division director and Evofem board member. “Phexxi offers women protection and control — on their terms, and at their discretion — without the use of hormones. I am proud to be a part of this team and this moment in history.”