The Food and Drug Administration is considering Boehringer Ingelheim's drug flibanserin for premenopausal women who report a lack of sexual desire, a market that 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, though, with many drugs abandoned after showing lackluster results.
The FDA will ask a panel of experts today to weigh in on the safety and effectiveness of Boehringer's drug. The agency is not required to follow the panel'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 such as depression, fainting and dizziness seen among women taking the pink pill.
The drug, which is related to the antidepressant family, affects serotonin and several other brain chemicals, though it's not clear how that increases 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 U.S. medical affairs.