Sprout’s Low Libido Drug Flibanserin Going To FDA Advisory Panel
This article was originally published in The Pink Sheet Daily
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.
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Experts convened by FDA to discuss female sexual dysfunction disorders, including problems with desire and arousal, settle on endpoints contrary to new DSM, but are in line with trials of Sprout’s flibanserin, the leading drug in development.
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.
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.