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Resurrected Flibanserin Filing Tests FDA Position On Female Sexual Desire Disorders

 
• By Emily Hayes

With a decision by FDA on a new filing for flibanserin possible by the fall, Sprout hopes to gain the first U.S. approval for treating women with low sexual desire. Meanwhile, Palatin forges on to Phase III with its female sexual desire disorder drug bremelanotide after discussing endpoints with FDA.

If successful, a resubmitted filing of flibanserin by Sprout Pharmaceuticals Inc. could provide a roadmap for drug development in female sexual dysfunction, a field that up to now has been marred by regulatory failures.

Flibanserin is an agonist of serotonin 5HT(1A) and an antagonist of 5-HT(2A) receptors. It is also a partial agonist of...

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