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.
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.
Flibanserin, which will be marketed as Addyi, is a once-a-day pill for women who are distressed by their low sex drive. Clinical trial data presented to the FDA showed that compared with study participants who got a sham medication, premenopausal 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.
Sprout Pharmaceuticals, a startup that in 2010 purchased the rights to sponsor flibanserin’s FDA application, said it expects to make Addyi available to patients starting 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 co-payment 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 Association 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 Tuesday, the FDA acknowledged it had continuing concerns about Addyi’s safety. The agency announced it had directed Sprout to conduct 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.
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