Drug made to boost women’s sex drive failed in studies, FDA says
WASHINGTON — A pink pill designed to boost sex drive in women — the latest attempt by the drug industry to find a female equivalent to Viagra — fell short in two studies, federal health regulators said yesterday.
The Food and Drug Administration is considering Boehringer Ingelheim’s drug flibanserin for premenopausal women who report a lack of sexual desire, a market drugmakers have been targeting for more than a decade since the blockbuster success of Viagra in men.
The search for “female Viagra,’’ has proved elusive, however, with many drugs abandoned after showing lackluster results.
Tomorrow, the FDA will ask a panel of specialists to weigh in on the safety and effectiveness of Boehringer’s drug. The agency is not required to follow the group’s advice, though it often does.
In its review posted online, the FDA said two Boehringer studies failed to show a significant increase in sexual desire, as recorded by women in a daily journal. Women taking the drug reported slightly more sexually satisfying experiences, but the FDA said that was not the primary measure of the study.
“The division wanted to see that an effect of treatment is an overall increase in sexual desire regardless of whether a sexual event occurred or not,’’ states the FDA review.
The FDA also noted increased side effects like depression, fainting, and dizziness among women taking the pink pill.
The drug, which is related to the antidepressant family, affects serotonin levels and several other brain chemicals, though it’s not clear how that boosts sex drive.
“We don’t know specifically what the exact mechanism of action is, but we believe it acts on brain chemicals that have a role in human sexual response,’’ said Dr. Peter Piliero, executive director for Boehringer’s US medical affairs.
Since the launch of Viagra in 1998, more than two dozen experimental therapies have been studied for “female sexual dysfunction,’’ a market some analysts estimate at $2 billion.
Pharmaceutical approaches to boosting female libido have evolved. Initially, most treatments aimed to increase blood flow to the genitals, similar to Viagra. A second wave focused on boosting hormones.
Medical surveys have estimated that more than 40 percent of women suffer from some form of sexual dysfunction.