The approval of Phexxi makes it the first non-hormonal prescription gel for the prevention of pregnancy.
In a historic move, the US Food and Drug Administration (FDA) has approved lactic acid, citric acid, and potassium bitartrate (Phexxi) for the prevention of pregnancy, according to a statement from Evofem Biosciences.
Designed for use as an on-demand method of contraception, the first and only FDA-approved non-hormonal gel for the prevention of pregnancy demonstrated an efficacy rate of 86.3% during a phase 3 clinical trial.
"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."
Expected to launch in early September, the non-hormonal, on-demand, vaginal pH regulator contraceptive is designed to maintain vaginal pH within the normal range of 3.5 to 4.5, which Evofem Biosciences notes is an acidic environment considered inhospitable to sperm. The approval is supported by data from the phase 3 AMPOWER clinical trial, which included more than 1000 patients.
The statement from Evofem Biosciences noted 0.36% of patients using lactic acid, citric acid and potassium bitartrate (Phexxi) experienced cystitis, pyelonephritis, and other upper urinary tract infections during clinical trials. The statement urges against use in females of reproductive potential with history of recurrent urinary tract infection or urinary tract abnormalities.
Other common adverse reactions (≥2%) seen with the vaginal gel in clinical trials were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain.
"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 statement. "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."