General Information

Phexxi is a combination of lactic acid, citric acid, and potassium bitartrate formulation as a vaginal gel.

Phexxi is specifically indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

Phexxi is supplied as a vaginal gel. Administer one pre-filled applicator of Phexxi (5 grams) vaginally immediately before or up to one hour before each act of vaginal intercourse. If more than one act of vaginal intercourse occurs within one hour, an additional dose must be applied. Five grams of Phexxi contains 90 mg of lactic acid, 50 mg of citric acid, and 20 mg of potassium bitartrate. Phexxi may be used during any part of the menstrual cycle. Phexxi may be used as soon as it is safe to resume vaginal intercourse after childbirth, abortion, or miscarriage. Phexxi may be used concomitantly with hormonal contraceptives; latex, polyurethane, and polyisoprene condoms; and vaginal diaphragms. Avoid Phexxi use with vaginal rings. Phexxi may be used concomitantly with other products for vaginal infections including miconazole, metronidazole, and tioconazole.

Mechanism of Action

Phexxi is a non-hormonal, on-demand, vaginal pH regulator contraceptive designed to maintain vaginal pH within the normal range of 3.5 to 4.5 – an acidic environment that is inhospitable to sperm.

Side Effects

Adverse effects associated with the use of Phexxi may include, but are not limited to, the following:

• vulvovaginal burning sensation
• vulvovaginal pruritus
• vulvovaginal mycotic infection
• urinary tract infection
• vulvovaginal discomfort
• bacterial vaginosis
• vaginal discharge
• genital discomfort
• dysuria
• vulvovaginal pain

Clinical Trial Results

The FDA approval of Phexxi was based on a multi-center, open-label, single-arm clinical trial in the United States. The study enrolled females of reproductive potential 18 to 35 years of age with regular menstrual cycles (21 to 35 days). The median age was 27.8 years. Subjects agreed to engage in at least 3 acts of heterosexual, vaginal intercourse per cycle. Subjects self-administered a 5 gram dose of Phexxi intravaginally up to one hour before each episode of intercourse for up to 7 cycles. The primary efficacy endpoint was the 7-cycle typical use cumulative pregnancy rate as derived by Kaplan-Meier life-table analysis. A total of 101 on-treatment pregnancies occurred in 1,183 subjects contributing 4,769 evaluable natural cycles. The 7-cycle cumulative pregnancy rate was 13.7%, excluding cycles with back-up contraception, cycles 35 days in length and cycles in which no intercourse was reported. The estimated Pearl Index, calculated based on data from the 7-cycle study, was 27.5.