FDA approves first on demand vaginal gel for contraception
FDA approves new class of female-controlled Birth Control for use In-the-moment -a safe,convenient non hormonal vaginal gel.
Food and drug Administration (FDA) has approved first non hormonal contraceptive vaginal gel for use as an on-demand method of contraception. Composed of lactic acid, citric acid, and potassium bitartrate (Phexxi) the gel demonstrated an efficacy rate of 86.3% during a phase 3 clinical trial for the prevention of pregnancy.
Phexxi is a 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.
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," said Saundra Pelletier, Evofem Biosciences' Chief Executive Officer. "Empowerment results from innovation and we are proud and excited to deliver new innovation to women in a category ready for change."
"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."
The Company expects to launch Phexxi in early September alongside the Phexxi Concierge Experience, a comprehensive patient and healthcare provider telemedicine support system. This robust offering of services is designed to provide physicians with on-demand educational support, and speed and simplify women's access to Phexxi. Through this offering, women would be able to secure a prescription, determine their insurance coverage and/or out-of-pocket costs, receive counseling support and refill reminders, and fill their prescription through their local neighborhood pharmacy or an online pharmacy that is expected to deliver Phexxi right to their door.
As the first vaginal pH regulator with a unique mechanism of action, the Company 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 for women in its Birth Control Guide.
Evofem is committed to ensuring access to Phexxi for all women seeking non-hormonal contraception, including for women who are not covered by government or private health plans, and will 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," said 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."
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