The US Food and Drug Administration allowed the endpoints for AMAG Pharmaceuticals Inc.'s Vyleesi (bremelanotide) Phase III program to evolve as the regulator gained more knowledge about hypoactive sexual desire disorder and experience with the clinical outcome assessments proposed for use.
AMAG’s Vyleesi Review Offers Lessons On Impact Of Patient Input
US FDA accepted change in Phase III endpoint hierarchy for the hypoactive sexual desire disorder drug based on input from a patient-focused drug development meeting and scientific workshop; bremelanotide review documents advise on use of multiple anchor scales to help interpret meaningfulness of changes in clinical outcome assessment scores.
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