Nearly four years after differences between U.S. and Russian clinical results derailed an NDA for its pregnancy prevention candidate, Phexxi, San Diego-based Evofem Biosciences Inc. has prevailed, winning FDA approval today for the vaginal pH regulator. It's the first non-hormonal contraceptive product in decades, according to the company. Combining lactic acid, citric acid and potassium bitartrate, it inhibits the motility of sperm.

The product, a vaginal gel with applicator, formerly known as Amphora, can be used as much as one hour before sex. It has the potential to reach up to 17 million women considered to be either "beyond hormone" or seeking and open to alternatives to hormonal contraception, according to company research.

Evofem hasn’t yet shared pricing of the drug. But during its first-quarter earnings call, Evofem’s chief commercial officer, Russell Barrans, said the wholesale acquisition cost for a box of 12 Phexxi applicators would likely be tween $250 and $275 and that the company expects women will refill their prescriptions an average of six or seven times per year.

The FDA approval arrives just days ahead of a May 25 PDUFA date. FDA reviewers took into account data from a single-arm phase III trial for Phexxi for the prevention of pregnancy in about 1,400 healthy women in the U.S. Called Ampower, the study demonstrated a cumulative pregnancy rate of 13.7% over seven cycles of use (95% CI 9.9, 17.4) in typical use, corresponding to an 86.3% efficacy rate and meeting the predetermined endpoint of the clinical trial.

Though Phexxi is described as not protecting against HIV infection or other sexually transmitted infections in its label, Evofem is evaluating the multipurpose product in its EVO-100 program for the prevention of urogenital transmission of both Chlamydia trachomatis infection and Neisseria gonorrhoeae infection in women and for reduction of recurrent bacterial vaginosis.

In December 2019, it reported top-line results from a phase IIb trial of EVO-100 called Amprevence for that indication. On its primary endpoint, investigators found a 50% relative risk reduction in chlamydia infection and a 78% relative risk reduction in gonorrhea infection vs. placebo.

Shares of Evofem (NASDAQ:EVFM) closed May 22 at $4.99, up 16 cents.

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