Pharmaceutical

FDA advisors recommend approving first-ever ‘female Viagra’

viagra FDA advisors recommend approving first ever female ViagraA “female Viagra” pill has gotten a nod by Food and Drug Administrator (FDA) advisors, paving the way for the first approved treatment for lack of sexual desire in women. The FDA will make the final decision whether to approve the drug for marketing. The agency is not required to follow the recommendations of its advisors, but it usually does.

Filbanserin, which would be marketed as Addyi if approved, has been rejected two previous times by FDA panels based on efficacy doubts and side effects concerns. Analysts were quick to raise doubts whether the additional data provided by drug maker Sprout Pharmaceuticals was enough to make the cut. The panel voted 18 to 6 to recommend approval but only if certain measures were taken to reduce side effect risks. The drug can cause women to faint and accidentally injure themselves. Alcohol use compounds the risk.

Women’s advocacy groups were already getting vocal with advisors, questioning whether there was a double standard and gender bias among drug regulators. Nearly two dozen medications have been FDA approved to treat low sex drive in men. Virtually none that boost women’s sexual desire have been approved.

Filbanserin, a selective serotonin reuptake inhibitor (SSRI) in the same class as brand-name medications Paxil and Zoloft, was originally made by Boehringer Ingelheim and tested to be an antidepressant. However, the drug failed in clinical trials.

In 2010, Boehringer sought to gain approval of the drug as a “female Viagra.” When the drug was rejected by FDA advisors based on insufficient efficacy data, Boehring gave up and sold the product to Sprout. The privately held drug company conducted more tests and re-filed with the FDA in 2013. For the second time, advisors rejected the drug but cited side effects, such as dizziness and fainting, as the reason.

Source: NY Times