(CMR) A birth control gel was recently approved by the Food and Drug Administration (FDA).
The gel made by the San Diego-based Evofem Biosciences expects to launch Phexxi in early September, alongside the Phexxi Concierge Experience, a comprehensive telemedicine support system.
The gel is the first non-hormonal contraceptive to be approved by the FDA since the female condom in 1993.
Phexxi works by making the pH levels in the vagina inhospitable to sperm if used up to an hour before sex. The gel comes in an applicator that women insert before sex. Phexxi contains lactic acid, citric acid, and potassium bitartrate, all of which are common food additives.
Saundra Pelletier, Chief Executive Officer of Evofem said the product is the only contraceptive with no hormones or systemic side that women are able to use only when necessary.
“The FDA approval of Phexxi means women now have access to a non-hormonal contraceptive option that they control, on their terms, to be used ONLY when they need it,” said Saundra Pelletier.
“Empowerment results from innovation and we are proud and excited to deliver new innovation to women in a category ready for change,” she added.
In a clinical study of 1,400 women, Phexxi was proven to be effective 93.3 percent of the time when used correctly.
10 percent of women who participated in the study experienced vaginal burning and itching, which were the most common side effects of the gel.
The birth control market is dominated by hormone-based birth control pills.