Timing Better For Sprout’s Latest Shot At First Female Sex Desire Drug
This article was originally published in The Pink Sheet Daily
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.
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Draft guidance says 'associated distress' may replace number of satisfying sexual events as a co-primary efficacy endpoint.
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.
Flibanserin development can move forward after dispute resolution, but women’s health advocates criticize the delay, charging that FDA has a double standard for female sexual dysfunction drugs.