Resurrected Flibanserin Filing Tests FDA Position On Female Sexual Desire Disorders
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.
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Filing for a drug with questionable risk-benefit profile was saved by a trial protocol redesign, strict safety labeling for a narrow indication, a REMS, patient mobilization and plenty of postmarketing studies. Trial period echoes FDA’s approach with a similar sector of lifestyle drug: obesity.
Originally developed by Boehringer Ingelheim, serotonin agonist and antagonist flibanserin is in position to be the first FDA-approved drug for female sexual desire disorders.
Sprout’s flibanserin resubmission should have an easier time at FDA, as experts backed key aspects of trial design used in flibanserin studies and patients sought treatment options at last year’s workshop on female sexual dysfunction.