Even though it’s been rejected twice, Sprout Pharmaceuticals is giving their female libido booster another shot at approval by the Food and Drug Administration.
Aided by a recent lobbying blitz by politicians, women’s groups and consumer advocates, Sprout Pharmaceuticals said recently it is refiling its application for the drug, flibanserin, adding new information requested by the FDA about how the drug affects driving ability.
The FDA most recently rejected the drug after nearly 10% of women in company trials reported sleepiness as a side effect.
If approved, the pill would be the first drug for women who report a lack of libido. But, it has already faced an uphill battle to get FDA approval because of lackluster effectiveness and side effects including fatigue, dizziness and nausea.
However, the recent lobbying efforts led by groups sponsored by Sprout and other drugmakers have begun 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. The petition garnered almost 25,000 supporters.
The FDA first rejected flibanserin in 2010 after a panel of expert advisers unanimously voted against the drug, saying its benefits did not outweigh its risks. The drug’s initial developer, Boehringer Ingelheim, abandoned work on the drug in 2011 and sold it to Sprout.