[Evofem News Releases, May 22, 2020] – Evofem Biosciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Phexxi™ (lactic acid, citric acid and potassium bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
Phexxi is the first non-hormonal, on-demand, vaginal pH regulator (VPR) 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. “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.”
IMPORTANT SAFETY INFORMATION
Indications and usage
Phexxi™ is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
Limitations of use
Phexxi™ is not effective for the prevention of pregnancy when administered after intercourse.
Warnings and precautions
Few cases (0.36%) of adverse reactions of cystitis, pyelonephritis and other upper urinary tract infection (UTI) have been reported in Phexxi™ clinical studies. Of these, one case of pyelonephritis was considered serious and required hospitalization. Avoid use of Phexxi™ in females of reproductive potential with history of recurrent urinary tract infection or urinary tract abnormalities.
Adverse reactions
Most common adverse reactions (≥2%) were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain.
Patients should be counseled on the following:
- To contact and consult their healthcare provider for severe or prolonged genital irritation or experiencing urinary tract symptoms.
- To discontinue Phexxi™ if they develop a local hypersensitivity reaction.
- That Phexxi™ does not protect against HIV infection or other sexually transmitted infections.