The FDA, the U.S. food and drug regulator, has approved a new type of contraceptive gel that will prevent unwanted pregnancies in a new way. The new contraceptive gel, called Phexxi, is a smudge, the report said. Produced by San Diego-based Evofem Biosciences, the gel contains lactic acid, citric acid and potassium tartaric acid, all of which are common food additives.
The researchers say the new gel bears some resemblance to spermicide, which prevents sperm from entering the uterus and slows it down. But Phexxi works differently.
The pH of the vagina ( a measure of acidity ) is usually between 3.5 and 4.5 , which is the level needed to maintain healthy bacteria. But sperm usually raises pH to 7 to 8, and Phexxi kills sperm by keeping pH in the usual acidic range.
Evofem says that unlike other contraceptives, Phexxi only needs to be used shortly before sex, and that the product is hormone-free and does not cause any additional side effects. It costs between $250 and $275, with 12 boxes in one box.
In a study of 1,400 women aged 18 to 35, Phexxi had an average effective rate of 86 percent over a seven-month period and more than 34,000 sexual acts in total. This works better than condoms, spermicides and other on-demand birth control pills.
Currently, the U.S. Food and Drug Administration approves Only Phexxi as a contraceptive. But Evofem says the gel also reduces the risk of gonorrhea and chlamydia infections. The company plans to begin a large patient study by the end of the year and then submit the results to the agency for approval as a second product.