A Viagra-like Pill for Women Gets Another Chance for FDA Approval

[Nelson Vergel]

The pill has been twice rejected, but Sprout Pharmaceuticals said Tuesday, Feb. 17, 2015, it is refiling its application for flibanserin, adding new information requested by the Food and Drug Administration about how the pill affects driving ability. Drugmakers frequently cite a 1999 survey in the Journal of the American Medical Association that found 43 percent of U.S. women had some type of sexual dysfunction.

Sprout said Tuesday it is refiling its application for flibanserin, adding new information requested by the FDA about how the pill affects driving ability. FDA scientists requested that data after their most recent rejection of the drug, in part, due to results showing nearly 10 percent of women in company trials reported sleepiness as a side effect.

http://www.dddmag.com/news/2015/02/...pill?et_cid=4421566&et_rid=449166332&type=cta

 

[Nelson Vergel]

More on HRT and sex drive in women:

http://www.excelmale.com/forumdisplay.php?81-HRT-in-Women

 

[Nelson Vergel]

The Food and Drug Administration will ask a group of outside medical experts next month to evaluate a much-debated experimental drug designed to boost sexual desire in women.

The meeting is the latest twist in the ongoing saga of flibanserin, a proposed female libido pill which the FDA has already twice declined to approve. But the drug's backer, Sprout Pharmaceuticals, has enlisted women's groups and other advocates to lobby the agency to approve the pill, saying women's sexual problems have been too long overlooked by the federal government.

The FDA said Thursday in a posting it will convene a meeting of its reproductive drugs and drug safety panels on June 4. The agency is not required to follow the advice of such panels, though it often does.

http://www.dddmag.com/news/2015/05/...et_cid=4560314&et_rid=449166332&type=headline