Just yesterday, the U.S. Food and Drug Administration (FDA) approved the use of flibanserin—to be sold under the name “Addyi”—for the treatment of sexual desire disorder in premenopausal women. The approval does come with certain limitations that emphasize how Addyi drastically differs from what its current moniker as the “female Viagra” may imply.
Flibanserin has actually been rejected twice before by the FDA, once in 2010 and again in 2013. This resulted in some charges of gender bias against the agency, as they had approved Viagra for men in 1998. The FDA has always denied the accusations, and the science is in its favor. Although off-handedly referred to as the female equivalent of the popular erectile dysfunction drug, there are several key differences.
Viagra is, at its core, a form of blood pressure medicine that treats a physical condition. Addyi, in contrast, addresses a mental condition called hypoactive sexual desire disorder (HSDD), which is characterized by a loss of sexual drive or fantasy in premenopausal women. Addyi works on the nervous system and is actually in the same category of drugs as antidepressants. Also, unlike Viagra, Addyi needs to be taken daily instead of on an as-needed basis.
The reason the drug was previously rejected is because more studies were needed to show that Addyi’s benefits outweighed its potential risks. Addyi can cause dangerously low blood pressure in some patients, sometimes enough to cause unconsciousness. The risk and severity of this side effect increase when alcohol has been consumed or if there are certain drug interactions. Doctors are urged to assess the likelihood of patients reliably avoiding alcohol when deciding to prescribe Addyi.
Addyi has been approved with a risk evaluation and mitigation strategy (REMS), meaning that only prescribers who are REMS certified and who properly counsel patients about side effects are able to write a prescription for it. There will also be a large boxed warning about the effects of alcohol consumption on blood pressure while taking the drug.
About one-third of adult women are believed to be experiencing HSDD. A month’s supply of Addyi, which goes on sale in October, is expected to cost about the same as a month’s supply of Viagra.
Sources for Today’s Article:
Goldschmidt, D., “‘Female Viagra’ Gets FDA Approval,” CNN web site, August 18, 2015; http://www.cnn.com/2015/08/18/health/female-viagra-fda-approval/index.html.
Goldschmidt, D. and Shoichet, C.E., “So-called ‘female Viagara’ gets nod from FDA advisory committee,” CNN web site, June 5, 2015; http://www.cnn.com/2015/06/04/health/female-viagra-sex-drive-drug-flibanserin/.
“FDA approves first treatment for sexual desire disorder,” U.S. Food and Drug Administration web site, August 18, 2015; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458734.htm.