Q&A: Female sex pill makes comeback with positive panel vote
Women suffering from low libido got some hope this week when a panel of health experts
How does the drug work?
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.
Whowouldtakethisdrug?
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.
Surveys estimate that between 5.5 million to 8.6 million U.S. women have the condition, or roughly 8 to 14 percent of women ages 20 to 49. Because so many other factors affect sexual appetite there are a number of alternate causes doctors must rule out before diagnosing the condition, including relationship problems, medical conditions, depression and mood issues caused by other medications like sleeping aids and painkillers.
The diagnosis is not universally accepted and many psychologists argue that low sex drive should not be considered a medical condition.
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.
The FDA panelists acknowledged this week that flibanserin will not help all patients. The percentage of patients reporting positive results with flibanserin was only 10 to 15 percent higher than among patients taking a placebo. That suggests as few as 1 in 10 patients may actually benefit from the drug, according to some FDA advisers.
Whatarethesideeffects?
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.