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US regulators approve new type of contraceptive gel

LINDA A. JOHNSON
This May 2020 photo shows Phexxi, a contraceptive made by San Diego-based Evofem Bioscience. The Food and Drug Administration on Friday, May 22, 2020 approved the new contraceptive. (Christine Blackburne via AP)

U.S. regulators on Friday approved a birth control gel that works in a new way to prevent pregnancy.

Phexxi comes in an applicator that women insert before sex. The gel made by San Diego-based Evofem Biosciences contains lactic acid, citric acid and potassium bitartrate, all of which are common food additives.

The new gel has some similarities to spermicides, which block the entrance to the cervix and slow sperm down. But Phexxi works differently.

The vagina’s pH — a measure of acidity — is typically in the range of 3.5 to 4.5, the level needed to maintain healthy bacteria. Sperm raise that to a more hospitable level of 7 to 8. Phexxi keeps it in the usual acidic range, killing the sperm.

Unlike some other contraceptives, it only needs to be used shortly before sex and it doesn’t contain hormones, which can cause side effects some women can’t tolerate.

The company said Phexxi — pronounced FECK’-see — will have a list price of $250 to $275 for a box of 12 without insurance.

In a study of 1,400 women aged 18 to 35, Phexxi was about 86% effective on average over seven menstrual cycles and a total of more than 34,000 acts of intercourse. That’s a bit better than condoms, spermicides and other “on-demand” contraceptives, but less effective than long-term methods such as IUDs and implants.

Phexxi’s side effects were minimal — mostly irritation and burning, which declined sharply after repeated use.

“This would be a pretty big deal,” if Phexxi’s effectiveness and safety in real-world use match results of the patient tests, said Dr. Luu Ireland, a University of Massachusetts contraception specialist. The more nonhormonal contraceptives available to women, the better, she added.

Phexxi appears to be a “terrific backup” method if used with a condom, said Dr. Lauren Streicher, medical director of the Northwestern Medicine Center for Sexual Medicine and Menopause in Chicago.

“If you have a guy who refuses to use a condom, this is a great option,” she added.

The Food and Drug Administration approved Phexxi only as a contraceptive, but Evofem said its testing indicates the gel also reduces the risk of infection by gonorrhea and chlamydia. U.S. cases of both infections have been rising for several years.

The company plans to start a large patient study by year's end, then submit results to the agency for approval as a second product, for preventing those infections.

Evofem could market it under a different name, and likely could tout Phexxi as both birth control and a way of helping to help prevent at least some sexually transmitted diseases.

“If that pans out, that would be quite revolutionary,” said Ireland.

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Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.