FDA Advisory Panel Backs First Low Libido Drug For Women

June 5, 2015 | Prachi Gupta

After being rejected twice, it looks flibanserin, the low libido drug for women, will become FDA-approved. If so, the drug will become the first sexual arousal for women on the market. The New Scientist reports that an FDA advisory panel approved it 18 to 6 on Thursday, provided that it comes “with a risk management program,” according to CNBC.

The FDA tends to follow the panel’s recommendations, and will make the final decision in August. Flibanserin, which will be branded as “Addyi” by Sprout Pharmaceuticals, could be available as early as next year.

Addyi has been touted as the “female Viagra,” but it does not work similarly to Viagra. Viagra increases blood flow to the genitals, but Addyi works on the brain:

Addyi is no Viagra though – women would have to take it every day, whether or not they want sex. And, while the famous little blue pill works by increasing blood flow to the genitals, this new drug instead alters brain chemistry, affecting receptors for various signalling chemicals including serotonin and dopamine.”

Sprout lobbied hard for the drug, saying that it’s sexist that there are many male-oriented sexual enhancement drugs, but none for women. While it’s true that the dearth of options for women should be corrected, however, it’s not clear that flibanserin is very effective. The drug has been controversial because it failed approval twice, and because its benefits are minimal. In trials, couples in which one partner used flibanserin, had sex “an average of once a month extra, from a baseline of two to three times a month.”

(Photo: Andrew Campbell)