The female sexual dysfunction drug candidate developed by Sprout Pharmaceuticals has been submitted to the Food and Drug Administration for review and an approval decision is expected by the end of the year.
If flibanserin gets the FDA’s O.K., Sprout’s drug would become the first so called ‘female Viagra’ drug approved for the market. Other companies that have tried to develop such products have either failed to win approval or have even failed to advance beyond clinical trials.
Raleigh-based Sprout’s new drug application (NDA) for flibanserin is a resubmission. Boehringer Ingelheim, the German company that originally developed the compound, submitted a flibanserin drug application to the FDA in 2010. The agency declined to approve the drug, raising questions about its efficacy and safety. Sprout licensed the compound from Boehringer Ingelheim in 2011. The “female Viagra” name is an unofficial one associated with the the drug the first time it was going through the development and review process but it has no association with Pfizer’s Viagra, nor it work by the same mechanism of action.
Flibanserin was developed to treat hypoactive sexual desire disorder in pre-menopausal women. HSDD is a condition characterized by diminished sexual desire. Sprout recently published positive phase III clinical trial results in the Journal of Sexual Medicine showing that flibanserin performed better than a placebo. The most frequently reported adverse events were drowsiness, dizziness and nausea.
“This additional data, which is a key part of Sprout’s resubmission of the flibanserin NDA, is responsive to feedback received from FDA previously,” Sprout Chief Operating Officer Cindy Whitehead said in a statement. “With this study, and other information included in our resubmission, Sprout believes that it has addressed the concerns raised by the FDA during its previous review. We look forward to working with the Agency during the ongoing review process.”
