Female sexual desire pill gets endorsement
Associated Press
For the first time, a government panel has endorsed a drug for women with low libido. The move surprised many experts, because the Food and Drug Administration has twice rejected the drug due to lackluster effectiveness and worrisome side effects.
The FDA will make a formal decision later this summer.
Here’s a look at the pill flibanserin from Sprout Pharmaceuticals, which some have dubbed “Female Viagra.” Q: How does the drug work? A: Flibanserin acts on brain chemicals associated with mood and appetite, similar to antidepressant drugs. In fact, it was originally studied as a treatment for severe depression before being repurposed into a libido drug. It’s not entirely clear why flibanserin increases sexual desire, but researchers point to its ability to increase dopamine — a brain chemical associated with appetite — while lowering serotonin — another chemical linked with feelings of satiation. Q: Who would take this drug? A: Sprout wants to market the drug to premenopausal women with hypoactive sexual desire disorder, described as a lack of sexual appetite that causes emotional distress. The diagnosis is not universally accepted, and many psychologists argue that low sex drive should not be considered a medical condition. Though not yet approved for sale, flibanserin was endorsed last week by an FDA panel. Q: Is the drug effective? A: Experts usually describe flibanserin’s effect as “modest.” In company studies, women taking flibanserin reported a slight increase in sexually satisfying events each month. Their answers to separate questionnaires indicated they experienced a slight increase in desire and a slight decrease in stress. While FDA scientists describe these effects as “small,” they were significant enough to meet FDA effectiveness standards. Q: What are the side effects? A: Flibanserin’s side effects have hampered its review at the FDA for years. About 10 percent of patients in Sprout’s studies experienced the most common problems: dizziness, fatigue and nausea.
The FDA’s current review focuses on problems that are rare but more serious, including dangerously low blood pressure and fainting. Those problems appear to increase when patients drink alcohol or take certain other medications, including antifungal drugs.
If the drug is approved, FDA advisers said special steps should be considered to minimize these risks, including:
A bold warning label not to drink or take certain other medications.
Educational pamphlets for patients about the side effects to be distributed by pharmacists.
Training requirements doctors must complete before prescribing the drug.
Q: Why did the drug get a positive vote this time around?
A: In 2010, a similar panel of FDA experts unanimously voted against flibanserin, saying its benefits did not outweigh its risks. They noted the drug failed to achieve a key study goal — increasing desire based on daily journal entries. Since then, Sprout conducted another study of sexual desire using a different method that achieved statistical significance. The company also conducted several safety studies that shed more light on flibanserin’s interactions with alcohol and other drugs. The studies showed links to low blood pressure and fainting.
The company also enlisted support from members of Congress and women’s groups who met with the FDA and pushed for the drug’s approval. Q: What happens now? A: The FDA is expected to rule on flibanserin in August.