Aug. 18--For the first time, the U.S. Food and Drug Administration has given its blessing to a prescription drug intended to increase sexual desire in women.
The FDA's green light on the drug flibanserin, often known by the nickname "pink Viagra," reverses two earlier decisions to reject the medication as a treatment for hypoactive sexual desire disorder, or HSDD.
The decision, announced late Tuesday, comes in the wake of a public campaign that has challenged the agency to close a widening gap between the numbers of medications available for men's sexual health and those available to women.
"Today's approval provides women distressed by their low sexual desire with an approved treatment option," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "We are committed to supporting the development of safe and effective treatments for female sexual dysfunction."
The drug is the first FDA-approved treatment for sexual desire disorders in either women or men, according to the agency.
Flibanserin, which will be marketed as Addyi, is a once-a-day pill for women who are distressed by their low sex drive. Women are not considered to have HSDD if their drop in sexual desire is due to another medical or psychiatric condition, a side effect of medication or a problem in their relationship.
Clinical trial data presented to the FDA showed that compared with study participants who got a sham medication, pre-menopausal women who took flibanserin reported a modest but measurable rise in sexual desire and increased the number of "sexually satisfying encounters" they had by roughly one per month.
In tests, the most common side effects of the drug included dizziness, sleepiness, nausea, fatigue and insomnia, the FDA said. Addyi is to be taken at bedtime to reduce these risks, according to the agency.
The drug appears to influence a neurotransmitter called serotonin, as do some types of antidepressants. However, the mechanism by which Addyi improves sexual desire is not understood.
Sprout Pharmaceuticals, a Raleigh, N.C., startup that in 2010 purchased the rights to sponsor flibanserin's FDA application, said it expected to make Addyi available to patients starting in mid-October. It is expected that gynecologists will be the main prescribers, but it could also by prescribed by primary care physicians and mental health professionals who specialize in sexual health.
Sprout Chief Executive Cindy Whitehead said the company expected to price a one-month supply so that women with insurance coverage could access the drug with a copayment of between $30 and $75 per month. Whitehead said the company was seeking to make Addyi as financially accessible to women as most erectile dysfunction drugs are to men.
Sprout's bid to get flibanserin approved by the U.S. drug agency on its third try has stirred controversy and wide debate -- among physicians, feminist groups, consumer advocates and researchers specializing in female sexuality.
In an editorial published by the Journal of the American Medical Assn. last month, three members of the FDA advisory panel that considered flibanserin in June complained that the agency was adjudicating questions about the drug's safety and effectiveness in a "politically charged atmosphere."
A campaign called "Even the Score" has suggested gender bias at the FDA has left women with sexual problems stranded, while waving through 26 products to enhance men's sex lives. The lobbying campaign was launched and largely funded by Sprout but joined by women's health advocates and consumer groups.
In approving the drug on Tuesday, the FDA acknowledged it had continuing concerns about Addyi's safety. The agency announced it had directed Sprout to conduct three additional tests of the drug in women who drink alcohol. Debates over the drug's safety have largely centered on its potential for inducing dizziness, lightheadedness or fainting caused by a sudden drop in blood pressure.
That danger appears greatest when those taking the drug are heavy consumers of alcohol, or take CYP3A4 inhibitors, a class of drugs that includes several antifungal medications, antibiotics, HIV drugs and some blood-pressure medications.
"Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified healthcare professionals and certified pharmacies," Woodcock said. "Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment."
The FDA will require a boxed warning to highlight these risks.
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UPDATE
4:40 p.m.: This story has been updated with additional information about hypoactive sexual desire disorder and side effects of the drug. It also includes comments from Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
It was originally published at 4:04 p.m.
