The Food and Drug Administration has approved Phexxi™ (lactic acid, citric acid and potassium bitartrate; Evofem Biosciences) 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 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 intercouse. Additionally, Phexxi may be used concomitantly with hormonal contraceptives, but should be avoided with vaginal rings.
The approval of Phexxi was based on data from an open-label, single-arm study that enrolled females of reproductive potential with regular menstrual cycles (median age: 27.8 years). Participants self-administered a 5g dose of Phexxi intravaginally up to 1 hour before each episode of intercourse for up to 7 cycles. The primary efficacy end point was the 7-cycle typical use cumulative pregnancy rate as derived by Kaplan-Meier life-table analysis.
Results showed a total of 101 on-treatment pregnancies occurred in 1183 participants contributing 4769 evaluable natural cycles. The 7-cycle typical use cumulative pregnancy rate was 13.7% (95% CI, 10.0-17.5) and the estimated Pearl Index was 27.5 (95% CI, 22.4-33.5).
With regard to safety, the most common adverse reactions (≥2%) included vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain. Phexxi should be avoided in patients with a history of recurrent urinary tract infection or urinary tract abnormalities.
The Company expects to launch Phexxi in early September 2020, along with the Phexxi Concierge Experience, a comprehensive patient and healthcare provider telemedicine support system.
Phexxi will be supplied as 5g prefilled single-dose vaginal applicators in a box of 12 units.
For more information visit evofem.com.