By Steve Shapiro
An advisory panel to the FDA has recommended approval of flibanserin, a drug touted by Sprout Pharmaceuticals to treat Hypoactive Sexual Desire Disorder in women--a persistent lack of desire for sex. The 18-6 vote came with stipulations from those in favor that measures be taken to reduce the drug's side effects that can include low blood pressure, fainting, sleepiness and nausea.
Thirty-year-old Katherine Campbell says she suffers from HSDD.
“After my first son was born, I noticed it right away. It was there one day, gone the next,” Campbell tells Yahoo Global News Anchor Katie Couric.
Experts in the field say it’s related to brain function.
“We know there is this area of the limbic system that is associated with the neurotransmitters dopamine and norepinephrine that is functioning differently in the women with HSDD,” says Leah Millheiser, MD, director of the Female Sexual Medicine Program at Stanford School of Medicine.
Sprout has been lobbying the Food and Drug Administration for years to approve its experimental drug, which would be the first treatment of its kind for this problem.
“Flibanserin is a novel, non-hormonal pill to treat hypoactive sexual desire disorder in premenopausal women,” says Sprout CEO Cindy Whitehead.
Critics say the so-called “little pink pill” has not proven to be safe or effective.
“This is a drug that’s meant to be taken every day for the rest of a woman’s life. We don’t know what the long-term effects are,” says Adriane Fugh-Berman, MD, associate professor at Georgetown University Medical Center and director of the research project PharmedOut. She also questions the validity of HSDD as a diagnosis.
“Low desire is not a medical condition, and in fact the term hypoactive sexual desire disorder has been eliminated from the latest ‘Diagnostic [and] Statistical Manual,’” Fugh-Berman says. “Low libido can be caused by a number of different things, including diabetes, depression, other medical conditions, medications — particularly antidepressants and relationship problems.”
The FDA balked in 2013 when Sprout resubmitted a new drug application for flibanserin, which had been rejected once before, while it was held by the German pharmaceutical company Boehringer Ingelheim, citing side effects such as sleepiness and nausea. It also refuted claims that the decision was in any way sexist.
“We do not believe there has been any gender bias with regard to our review of this drug,” the agency said in a statement. “We engaged in a scientific process in which we evaluated whether the drug’s benefits outweigh its risk.”
Sprout resubmitted flibanserin for FDA approval in February.
A decision by the FDA is expected in August.