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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Chronicle of the development and review of AMAG Pharmaceuticals’ bremelanotide for premenopausal women with acquired, generalized hypoactive sexual desire disorder.