No Female Viagra Pills! FDA says pill is a failure in test!

A pink pill designed to offer women a counterpart to Viagra failed to boost female sex drive in two studies, U.S. drug reviewers said in documents released on Wednesday.

Women who took Boehringer Ingelheim's experimental drug flibanserin also reported depression, fainting, fatigue and other problems. The drug's tolerability was "only moderate," Food and Drug Administration staff said.

An FDA advisory panel meets Friday to weigh whether to recommend approval for flibanserin. The once-a-day pill, nicknamed the "pink Viagra," is the latest attempt at a female version of Pfizer Inc's blockbuster blue pill for men.

Drugmakers have long sought to tap a potentially lucrative market for a medication to boost a woman's libido. Viagra and other male impotence drugs have failed to help women.

Boehringer is seeking FDA approval to sell its pill by prescription for treating premenopausal women with hypoactive sexual desire disorder, defined as a lack of sex drive in otherwise healthy women.

The proposed brand name is Girosa. It is not yet approved anywhere in the world.

FDA staff, in a preliminary review, outlined "major" concerns on the company's effectiveness data. In two clinical trails, the drug increased the number of sexually satisfying experiences but failed to improve sexual desire.

"Therefore, neither study met the agreed-upon criteria for success in establishing" efficacy, the reviewers wrote in a summary prepared for the advisory panel.

Fatigue, drowsiness and sedation were "commonly reported" and "it is not clear if labeling alone will be sufficient to alert women to the numerous drug interactions that exist with flibanserin," they said.

Depression, fainting and accidental injury also were more frequent with the drug than a placebo.

Nearly 15 percent of women who took the recommended flibanserin dose stopped taking it before the study ended due to possible side effects, FDA staff added.

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