FDA OKs Phexxi, a Contraceptive Touted to Reduce STI Risk

SAN DIEGO — The Food and Drug Administration today approved Phexxi, a new birth control gel that also has been touted to reduce the risk of contracting gonorrhea and chlamydia. Phexxi — a porny-sounding brand that is pronounced “feck-see” — comes in an applicator that women insert before sex and contains lactic acid, citric acid and potassium bitartrate, all of which are common food additives. It does not contain hormones, which can cause side effects. Made by Evofem Biosciences, the gel has similarities to spermicides, which block the entrance to the cervix and slow sperm down. But Phexxi works differently. The vagina’s pH is typically in the range of 3.5 to 4.5, an acidic level needed to maintain healthy bacteria. Sperm raises that to 7 to 8. Phexxi keeps it in the range of 3.5 to 4.5, killing the sperm. Regulators green-lighted Phexxi only as a contraceptive, but Evofem said its testing indicates the gel also reduces the risk of contracting gonorrhea and chlamydia. San Diego-based Evofem plans to start a patient study by year's end, then submit results to the FDA for approval as a secondary product for preventing those infections. Evofem said it is working to have Phexxi covered under the Affordable Care Act, which mandates that private health plans provide coverage with no out-of-pocket costs for women. Phexxi will have a suggested price of $250 for a box of 12 when it debuts in September, Evofem said.