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March 01, 2016

New study questions FDA approval of female libido drug

European study finds that benefits of Addyi are small compared to side effects

It took Sprout Pharmaceuticals three tries to get the Food and Drug Administration to approve its female libido drug, flibanserin. But the results were oh so satisfying: just two days after the drug was approved this past August, Valeant Pharmaceuticals bought up Sprout for $1 billion.

"Very satisfying for Sprout, but what about the women who take flibanserin?" Drs. Steven Woloshin and Lisa Schwartz, both affiliated with Dartmouth, wrote in an editorial published Monday in JAMA Internal Medicine.

The editorial accompanies a new study published in the same journal that questions the FDA's decision to approve the drug, marketed as Abbyi, which aims to increase female sexual desire.

After analyzing results from eight trials involving almost 6,000 women, researchers in Belgium and Holland found that the drug hailed as "female Viagra" quadruples the risk of side effects like dizziness and sleepiness.

Those side effects are not very serious, but researchers also found that the benefits of the drug were "minimal."

"Women taking the approved dose — compared with placebo — experienced 0.5 more satisfying sexual encounters a month and scored 0.3 points higher on a 5-point sexual desire scale," wrote Woloshin and Schwartz, leading one to wonder what exactly one-half of a satisfying sexual encounter feels like.

The two doctors also criticized the quality of the evidence that Sprout submitted to the FDA. In a trial that tested how the female desire drug interacted with alcohol, for example, all of the participants were men. (The trial still found that the drug should not be used with alcohol, leading the FDA to require a warning on the label.)

Valeant's chief medical officer, Dr. Tage Ramakrishna, defended the drug in a statement released to Reuters

"It is crucial that women suffering from HSDD [hypoactive sexual desire disorder] are able to speak to their physicians about the full range of options...Analyses such as the one published in JAMA Internal Medicine, by omitting context and downplaying the importance of increased sexually satisfying events to those with HSDD, makes that conversation more difficult," he said.

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