FDA Approves Phexxi for Use as On-Demand Contraceptive

Lucas Franki

Disclosures

May 26, 2020

The Food and Drug Administration has approved Phexxi (lactic acid, citric acid and potassium bitartrate) to prevent pregnancy in women of reproductive potential.

Evofem Biosciences expects to release Phexxi – the first nonhormonal, on-demand, vaginal pH regulator contraceptive designed to maintain vaginal pH within the range of 3.5-4.5 – in September 2020 alongside the Phexxi Concierge Experience, a comprehensive patient and health care provider telemedicine support system, according to the company's press release. The service is designed to provide physicians with on-demand educational support, and to speed and simplify women's access to Phexxi.

In an open-label multicenter trial, women aged 18-35 with regular menstrual cycles intravaginally administered a 5-gram dose of Phexxi vaginal gel up to 1 hour prior to intercourse; they did so for up to seven cycles. There were 101 pregnancies in 1,183 subjects during 4,769 cycles. The 7-cycle cumulative pregnancy rate was 14% (95% confidence interval: 10.0%, 17.5%).

The most common adverse events associated with Phexxi were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, bacterial vaginosis, vaginal discharge, dysuria, and vulvovaginal pain.

This story originally appeared on MDedge.com.

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