Evofem Biosciences Inc. announced that the U.S. Food and Drug Administration has approved Phexxi vaginal gel for the prevention of pregnancy.
According to Evofem, Phexxi is 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.
“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, in a news release.
Evofem expects to launch Phexxi in early September alongside the Phexxi Concierge Experience, a comprehensive patient and health care provider telemedicine support system, according to the company.
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, Evofem said.
“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.”