FDA approves Evofem's non-hormonal contraceptive gel Phexxi
Evofem Biosciences said its contraceptive Phexxi (L-lactic acid/citric acid/potassium bitartrate) received FDA approval Friday, making it the first non-hormonal prescription gel for the prevention of pregnancy. The company indicated that Phexxi will carry a list price between $250 and $275 for a box of 12 packs, although the product's launch will be delayed to the first week of September due to disruptions stemming from the COVID-19 pandemic.
The FDA decision "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," commented CEO Saundra Pelletier.
Evofem resubmitted its filing for Phexxi, formally known as Amphora, to the US regulator last November, supported by data from the Phase III AMPOWER trial of roughly 1400 healthy women aged 18 to 35 years. According to the company, the trial was designed with input from the FDA to address questions raised in a complete response letter issued to Evofem in 2016.
Top-Line data from the trial demonstrated that Phexxi was associated with a cumulative pregnancy rate of 14% over seven cycles of use, corresponding to an 86% efficacy rate for "typical use," which met the study's primary endpoint. The contraceptive gel also had 98.7% efficacy when used as directed.
Acidic pH 'inhospitable to sperm'
HC Wainwright analyst Raghuram Selvaju estimated that Phexxi could bring in peak sales of $500 million by 2030. According to Evofem, the contraceptive gel, applied in the vagina using an applicator up to one hour before sexual intercourse, is designed to maintain vaginal pH within the normal range of 3.5 to 4.5, an "acidic environment that is inhospitable to sperm."
Meanwhile, the drug is also being studied in the Phase IIb AMPREVENCE trial for the prevention of chlamydia and gonorrhoea in women. Evofem plans to start a large study by year's end, then submit results to the US regulator for approval as a second product, for preventing these sexually transmitted diseases.