The Food and Drug Administration announced on Feb. 23 the authorization of the marketing of the first condoms specifically to reduce sexually transmitted infections during anal intercourse. The condoms will be marketed as One Condoms, which can also be used for vaginal intercourse to prevent STIs and 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, PhD, director of the FDA's Office of Gastrorenal, OB-GYN, 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," said Lias.

According to the FDA, anal intercourse carries the greatest sexual exposure risk of HIV transmission, which consistent and correct use of condoms can significantly lower.

One Condoms are a natural rubber latex sheath covering the penis. It comes in three versions: standard, thin, and fitted. The fitted version is available in 54 sizes and includes a paper template to assist users in finding the best condom. When used during anal intercourse, One Condoms should be used with a condom compatible lubricant.

For the clinical trials of One Condoms, 252 men who have sex with men and 252 men who have sex with women from the ages of 18 to 54 years participated. The total condom failure rate was 0.68% for anal intercourse, and 1.89% for vaginal intercourse. (The failure rate is defined as the number of slippages, breakages, or both events that occurred over the total number of sexual acts performed.)

In total, the number of adverse events was 1.92%. Adverse events reported during One Condoms clinical trials included an STI or recent STI diagnosis rate of 0.64%, a lubricant- or condom-related discomfort rate of 0.85%, a partner discomfort with lubricant rate of 0.21%, and a partner urinary tract infection rate of 0.21%.

One Condoms was reviewed by the FDA through the De Novo premarket review pathway, which is a regulatory pathway for low- to moderate-risk devices of a new type.

"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," said Lias.

The FDA is also establishing special controls criteria, which define the requirements related to labeling and performance testing. Once these criteria are met in combination with general controls, there will be a reasonable assurance of the condom's safety and effectiveness, according to the FDA.