(Bloomberg) — The first pill for low libido in women will go on sale in the U.S. after regulators decided that despite its modest benefit and serious side effects, the drug was worthwhile to address an affliction with no other approved treatments.
The Food and Drug Administration said Tuesday that doctors will have to take a training course to be certified to prescribe Sprout Pharmaceuticals Inc.’s Addyi, which will be available as soon as Oct. 17. And patients must sign a form acknowledging risks that include fainting and extreme sleepiness.
Those precautions apply to a drug that has shown in clinical trials to improve sexual desire in patients only slightly. That means closely held Sprout still will have to persuade doctors to prescribe Addyi and insurers to cover the pill, which must be taken daily and will cost about $350 to $400 a month before insurance coverage. Sprout expects insurers to put the drug in tier 2 or 3 on their formularies with a $30 to $75 copay.
“With any kind of medication you always have to balance the benefit with the risk,” said Holly Thacker, director of the Cleveland Clinic Center for Specialized Women’s Health. “Yes, there are side effects. They’re not life-threatening and they’re not outside the norm of medications in a similar class,” such as neurotransmitters for conditions like depression.
In clinical trials, women who took Addyi recorded a median increase of 0.5 to one more satisfying sexual events each month than those who got a placebo. Women began the trials experiencing two to three satisfying sexual events a month. Some women experienced as many as six to eight more satisfying sexual events each month, Sprout Chief Executive Officer Cindy Whitehead said in a phone interview.
The FDA had previously rejected the drug in 2013 for its modest effect, and then faced a backlash from some doctors and researchers who claimed the agency was being sexist. Drugs to treat male sexual dysfunction have become ubiquitous since Pfizer Inc.’s Viagra was approved in 1998. Viagra generated $1.69 billion in sales last year.
Unlike Viagra, which helps men who want to have sex get an erection by increasing blood flow to the penis, Addyi is designed to alter the brain chemistry of women so they find sex more desirable. The drug targets neurotransmitters such as dopamine and norepinephrine that the brain uses to transmit information and can affect mood. Antidepressant drugs use similar mechanisms.
Addyi, also called flibanserin, is approved for women diagnosed with a condition called hypoactive sexual desire disorder, which is low libido that causes stress. Whitehead said doctors will be able to get certified to prescribe the drug by watching an online video.