FDA Approves First Nonhormonal Prescription Gel to Prevent Pregnancy

The FDA recently approved a vaginal gel (Phexxi, Evofem Biosciences, Inc) that acts as a method of contraception for women.

It is the first nonhormonal, vaginal pH regulator contraceptive tobe 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 a statement from Evofem Biosciences, Inc.

“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. Many of my patients have cycled through numerous contraceptive options and still have not found the right fit for their sexual and reproductive needs,” Michael A. Thomas, MD, chairman of the Department of Obstetrics and Gynecology at the University of Cincinnati College of Medicine in Ohio, said in a statement.

“Phexxi offers women freedom from hormones and control over how they choose to prevent pregnancy,” he said. “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 health care provider and patient telemedicine support system that will allow ease of access for women and provide physicians with educational support.

Through the Phexxi Concierge Experience, women can obtain a prescription, determine their insurance coverage and/or out-of- pocket costs, fill their prescription through their community phar- macy or an online pharmacy, and receive counseling support and refill reminders.

“The FDA approval of Phexxi means women now have access to a nonhormonal contraceptive option that they control, on their terms, to be used only when they need it,” Saundra Pelletier, Evofem Biosciences’ chief executive officer, said in a statement. “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 of cystitis, pyelonephritis, and other upper urinary tract infections were reported.

Of the reported adverse events, 1 case of pyelonephritis was found to be serious and resulted in hospitalization.

For this reason, the company said that it does not recommend that women with a history of recurrent urinary tract infections or urinary tract abnormalities use the gel, according to the statement.

The company is working to ensure that the gel is covered under the Affordable Care Act. The Affordable Care Act requires private health plans to provide coverage with no out-of-pocket costs for 1 treatment per class in all 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 assis- tance program to ensure that all eligible women have access to the gel.

REFERENCE

U.S. FDA approves Evofem Biosciences’ Phexxi (lactic acid, citric acid and potassi- um bitartrate), the first and only non-hormonal prescription gel for the prevention of pregnancy. News release. Evofem Biosciences, Inc; May 22, 2020. Accessed May 26, 2020. https://www.biospace.com/article/releases/u-s-fda-approves-evofem-bioscienc- es-phexxi-lactic-acid-citric-acid-and-potassium-bitartrate-the-first-and-only-non-hor- monal-prescription-gel-for-the-prevention-of-pregnancy/