The Food and Drug Administration (FDA) has extended the shelf life of Phexxi® (lactic acid, citric acid, potassium bitartrate) vaginal gel from 36 months to 48 months.
Phexxi is a nonhormonal, on-demand contraceptive designed to regulate vaginal pH in the range of 3.5 to 4.5, maintaining an acidic environment that is inhospitable to sperm. The vaginal gel is self-administered via a prefilled applicator immediately before or up to 1 hour before each act of vaginal intercourse. Phexxi is not effective for the prevention of pregnancy after intercourse.
The FDA approved Phexxi for use as an on-demand method of contraception in 2020. The approval was based on data from an open-label, single-arm phase 3 study (ClinicalTrials.gov Identifier: NCT03243305) that assessed the efficacy and safety of Phexxi in women aged 18 to 35 years who are at risk of pregnancy.
“The FDA’s approval to extend Phexxi’s shelf life to 4 years speaks not only to the safety of our ingredients but also to the exceptional standards applied in the manufacturing of Phexxi,” said Saundra Pelletier, CEO at Evofem.
Phexxi is supplied as 5g prefilled single-dose vaginal applicators in a box of 12 units.
The vaginal pH regulator is also being evaluated for the prevention of chlamydia and gonorrhea in women in the phase 3 EVOGUARD trial (ClinicalTrials.gov Identifier: NCT04553068). Topline data from the study are expected later this year.
US Food and Drug Administration extends Phexxi® shelf life to four years. News release. Evofem Biosciences, Inc. Accessed June 2, 2022. https://www.prnewswire.com/news-releases/us-food-and-drug-administration-extends-phexxi-shelf-life-to-four-years-301559998.html