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Yesterday the FDA approved flibanserin, a treatment for some premenopausal women who have lost their desire for sex.
This was the third time the drug has come up for approval: it was rejected in 2010 and 2013 because the FDA thought its common side effects–particularly fainting and low blood pressure–outweighed its benefits. This time around, Sprout Pharmaceutical presented data from a large clinical trial that showed the drug did improve desire over placebo–though modestly–and identified serious interactions with both alcohol and CYP3A4 inhibitors. (They also helped develop a controversial patient advocacy campaign that pretty much accused the FDA of sexism for not approving the drug sooner.)
Sprout Pharmaceutical will market the drug as Addyi, and plans to make it available by October 17, 2015. Get ready for the avalanche of ads showing women in soft-focus fields of flowers telling you to “ask your doctor”.
FDA Approves a Pill for Female Sexual Desire Disorder, But It
This was the third time the drug has come up for approval: it was rejected in 2010 and 2013 because the FDA thought its common side effects–particularly fainting and low blood pressure–outweighed its benefits. This time around, Sprout Pharmaceutical presented data from a large clinical trial that showed the drug did improve desire over placebo–though modestly–and identified serious interactions with both alcohol and CYP3A4 inhibitors. (They also helped develop a controversial patient advocacy campaign that pretty much accused the FDA of sexism for not approving the drug sooner.)
Sprout Pharmaceutical will market the drug as Addyi, and plans to make it available by October 17, 2015. Get ready for the avalanche of ads showing women in soft-focus fields of flowers telling you to “ask your doctor”.
FDA Approves a Pill for Female Sexual Desire Disorder, But It
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