FDA Approves First Non-Hormonal Prescription Gel for Pregnancy Prevention
The FDA recently announced its approval of a vaginal gel that acts as a method of contraception for women. It is the first non-hormonal, vaginal pH regulator contraceptive to be approved by the FDA.
The FDA recently announced its approval of a vaginal gel (Phexxi, Evofem Biosciences) that acts as a method of contraception for women. It is the first non-hormonal, vaginal pH regulator contraceptive to be approved by the FDA.
The gel works by maintaining the vaginal pH within the normal range of 3.5 to 4.5, which is an acidic environment that does not allow sperm to survive, according to an Evofem Biosciences press release.
"There have been a limited number of advances in birth control over the last 2 decades; Phexxi represents an important step forward in women's health," said Michael A. Thomas, MD, chair of the Department of Obstetrics and Gynecology at the University of Cincinnati College of Medicine, in a press release. "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 plans to launch the gel in early September, with the support of the Phexxi Concierge Experience, which is a patient and health care provider telemedicine support system that will allow ease of access for women and will provide physicians with educational support.
Through the Phexxi Concierge Experience, women can get a prescription, determine their insurance coverage and/or out-of-pocket costs, receive counseling support and refill reminders, and fill their prescription through their community pharmacy 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," said Saundra Pelletier, Evofem Biosciences' chief executive officer, in a press release. "Empowerment results from innovation and we are proud and excited to deliver new innovation to women in a category ready for change."
During the clinical studies, a few cases (0.36%) of adverse events (AEs) of cystitis, pyelonephritis, and other upper urinary tract infection (UTI) were reported. Of the reported AEs, a case of pyelonephritis was found to be serious and resulted in hospitalization. For this reason, the company explained that it does not recommend that women with a history of recurrent UTIs or urinary tract abnormalities use the gel, according to the press release.
The company is working to ensure that the gel is covered under the Affordable Care Act (ACA). The ACA requires private health plans to provide coverage with no out-of-pocket costs for 1 treatment per class in all of the classes identified by the FDA in its Birth Control Guide.
However, for women who are not covered by government or private health plans, the company is providing a financial assistance program to ensure that all eligible women have access to the gel.
U.S. FDA Approves Evofem Biosciences' Phexxi™ (lactic acid, citric acid and potassium bitartrate), the First and Only Non-Hormonal Prescription Gel for the Prevention of Pregnancy [news release]. San Diego, CA: Evofem Biosciences, Inc.; May 22, 2020. Accessed May 26, 2020.