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FDA Authorizes First Condom for Anal Intercourse

The FDA approved the One Male Condom as the first condom approved and proven to protect against STIs and HIV during anal sex.

Yesterday, the One Male Condom became the first condom approved for anal sex by the US Food and Drug Administration (FDA).

The condom is specifically designed to prevent the transmission of HIV during anal sex, though it is also authorized for use during vaginal sex. The risk of HIV infection is 28-fold higher for men who have sex with men than for men who have sex with women, so an approved condom for this population was imperative.

Healthcare experts have long supported this move, in hopes that the authorization would encourage condom usage and reduce rates of STIs and HIV. The FDA had previously withheld approval of any condoms for anal sex, requiring the failure rate be proven as less than 5%.

The One Male Condom exceeded this requirement, with a failure rate (as measured by slippage or breakage) of 0.68% during anal intercourse and 1.89% during vaginal intercourse. The clinical trial, originally published in late 2019, also found that 69% of men who have sex with men reported they would use condoms more frequently if there were FDA-indicated condoms for anal sex.

Condoms have long been recommended for use during anal sex by the US Centers for Disease Control and Prevention (CDC), but the One Male Condom is the first condom specifically proven and approved to protect against STIs and HIV.

The FDA acknowledged the disproportionate rates of STI transmission during anal intercourse, adding that unprotected anal intercourse is the greatest sexual exposure risk of HIV transmission. Courtney Lias, PhD, a director in the FDA’s Center for Devices and Radiological Health, said, “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 should be used with condom compatible lubricant, the FDA said. The approved condoms are available in 54 different sizes, and come in standard, fitted, and thin varieties.

The FDA granted marketing authorization for the One Male Condom to Global Protection Corp. The condom was approved through the De Novo premarket review pathway for new, low- to moderate-risk devices.

The One Male Condom had an overall 1.92% rate of adverse events, including recent or symptomatic STI diagnosis, condom or lube-related discomfort, partner discomfort, and partner urinary tract infection. The study authors and FDA noted that STIs were not verified before the start of the trial, indicating the STIs may have occurred before the study participants began using the One Male Condom.