FDA Authorizes Marketing of First Condom Specifically For Anal Intercourse

Today, the U.S. Food and Drug Administration authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse. The condoms, which will be marketed as the One Male Condom, are also indicated as a contraceptive to help reduce the risk of pregnancy and the transmission of STIs during vaginal intercourse.

Condom companies are now able to market a condom that is specifically designed for anal sex. The FDA makes the move to help prevent STD’s, HIV, and other sexually transmitted diseases with the authorization.

Before today’s authorization, the FDA had not cleared or approved condoms specifically indicated for anal intercourse. Unprotected anal intercourse carries the greatest sexual exposure risk of HIV transmission. Consistent and correct condom use has the potential to significantly help decrease the risk of STIs. While today’s authorization underscores the public health importance of condoms tested and labeled specifically for anal intercourse, all other FDA-cleared condoms can continue to be used for contraception and STI prevention. It’s important to continue to use condoms consistently and correctly to reduce the risk of STI transmission, including HIV, and to prevent pregnancy.

“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse. The FDA’s authorization of a condom that is specifically indicated, evaluated, and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse,” said Courtney Lias, Ph.D., director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health. “Furthermore, this authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations. This De Novo authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster.”

The One Male Condom is a natural rubber latex sheath that covers the penis. It has three different versions: standard, thin, and fitted. The fitted condoms, available in 54 different sizes, incorporate a paper template to aid in finding the best condom size for each user. When used during anal intercourse, the One Male Condom should be used with a condom-compatible lubricant.

The safety and efficacy of the One Male Condom was studied in a clinical trial comprised of 252 men who have sex with men and 252 men who have sex with women. All participants were between 18 through 54 years old.

Source FDA.gov and RobinhoodNews.com


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