Evofem Biosciences announced the commercial launch of 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 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. Additionally, Phexxi may be used concomitantly with hormonal contraceptives, but should be avoided with vaginal rings.
In May 2020, the Food and Drug Administration (FDA) approved Phexxi 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). Findings 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.
“As a leader of innovation in women’s healthcare, we are thrilled to usher in a new era of sexual and reproductive health with the launch of Phexxi,” said Saundra Pelletier, Evofem Biosciences’ CEO. “Millions of women have either settled for less or completely opted out of using birth control because they have had enough with side effects and lack of control. Today, we are fulfilling Evofem’s mission of delivering a novel contraceptive option that women have been waiting for.”
The Company is also launching the Phexxi Concierge Experience, a comprehensive patient and healthcare provider telemedicine support system to help ensure Phexxi is accessible.
Phexxi is available through retail pharmacies and the Company’s mail order pharmacy partner, KnippeRx, as 5g prefilled single-dose vaginal applicators in a box of 12 units.
For more information visit phexxi.com.
- Evofem Biosciences announces US commercial launch of Phexxi™ (lactic acid, citric acid and potassium bitartrate), the first and only non-hormonal, on-demand prescription contraceptive vaginal gel. https://www.prnewswire.com/news-releases/evofem-biosciences-announces-us-commercial-launch-of-phexxi-lactic-acid-citric-acid-and-potassium-bitartrate-the-first-and-only-non-hormonal-on-demand-prescription-contraceptive-vaginal-gel-301124288.html. Accessed September 8, 2020.
- Phexxi [package insert]. San Diego, CA: Evofem Biosciences; 2020.
This article originally appeared on MPR