Pharmaceutical

FDA to take a third look at safety, effectiveness of female Viagra

viagra FDA to take a third look at safety, effectiveness of female Viagra Sprout Pharmaceuticals is resubmitting its so-called female Viagra in hopes of gaining approval from drug regulators despite two previously failed attempts at approval based on safety concerns. If approved, the drug, fibanserin, would be the first medication designed to boost female libido to hit the market.

Drug makers have been working for years to develop a drug to help women who lack sexual desire ever since the blockbuster success of Viagra for men. Sprout’s previous attempts at Food and Drug Administration (FDA) approval were squashed due to questions about effectiveness and concerns about side effects such as fatigue, dizziness and nausea. The new application includes information about how fibanserin affects driving ability.

Sprout is also hoping to sway FDA approval by publicizing the lack of a “female Viagra” as a women’s rights issue. “Women deserve equal treatment when it comes to sex,” states an online petition to the FDA organized by the group Even the Score, which is funded by Sprout and other drug companies.

Drug maker Boehringer Ingelheim developed fibanserin and sought FDA approval in 2010, but an advisory panel rejected the drug based on safety concerns. In 2011, Boehringer Ingelheim sold the drug to Sprout, which resubmitted the drug application in 2013 with new information regarding the drug’s safety and efficacy. However, the FDA again rejected the drug based on the same concerns.

Sprout filed a formal dispute against the agency. Regulators agreed to give the drug another look provided Sprout provide more details on how the drug affects driving and how the medication interacts with other drugs.

Sprout also enlisted the help of some members of Congress, who sent a letter to the FDA asking that the agency reassess the drug as women deserve at least one treatment for low sex drive.

There are currently 24 drugs approved to treat male sexual dysfunction.

Source: PharmPro