Female Viagra May Finally Get FDA Approval: Third Time is the Charm

After getting rejected twice by FDA and once by the independent Advisory Committee, the female libido drug flibanserin, commonly called Pink Viagra, finally won recommendation for approval by the Advisory Committee with FDA’s decision coming in August. The drug has very limited benefits with clinical trial participants expressing one half to one additional sexual episode compared to placebo. The drug causes serious side effects such as nausea, dizziness and fatigue, linked to certain other medication and alcohol consumption. The drug also boosts dopamine, and lower serotonin leading some increase in appetite and feelings of satiation. But the advisory panel opined that something is better than nothing. Flibanserin was originally being developed as an anti-depressant but was found to increase female libido, encouraging the developer, Sprout Pharmaceuticals, to change track mid-development and target low female libido in post-menopausal women. The key argument made at the advisory committee was lack of any treatment for female sexual disorder with Sprout even accusing FDA of gender bias against this drug compared to the standards used to approval Viagra for male sexual performance almost 17 years ago. The argument appears to have moved the panel. We will know in 2 months if that was enough to move FDA as well.