No pudo ser...
June 16 (Bloomberg) -- Boehringer Ingelheim GmbH’s sexual desire drug flibanserin may not be effective or safe, according to U.S. regulators weighing whether to approve the first pill designed to boost women’s libidos.
The drug “failed to demonstrate a statistically significant improvement” in sexual desire, Food and Drug Administration staff said in a review released today. It was also linked to appendicitis, depression and loss of consciousness. Side effects led about 15 percent of women to stop treatment with the drug, the review said.
While male sexual enhancement treatments led by Pfizer Inc.’s Viagra facilitate erections by increasing blood flow to the penis, flibanserin is designed to work in the brain. Boehringer’s libido pill, first tested as an antidepressant, lowers the level of one brain chemical, serotonin, and boosts production of two others, dopamine and norepinephrin.
“The evidence that I’d seen about flibanserin did not seem to suggest that it was very effective,” Kim Wallen, a professor of psychology and behavioral neuro-endocrinology at Emory University in Atlanta, said today in an interview. “This isn’t a good way to start an FDA hearing on approval of a drug.”
Boehringer, the world’s largest closely held drugmaker, asked the FDA to clear its pill to treat pre-menopausal women who suffer from hypoactive sexual desire disorder. Outside advisers to the FDA are scheduled to meet June 18 to review the safety and efficacy of the drug.
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