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Vyleesi Cinical Development Timeline

Executive Summary

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

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Vyleesi Reviewers

US FDA staff who participated in the review and approval of AMAG’s bremelanotide for hypoactive sexual desire disorder.

Vyleesi’s Approval Delayed By Blood Pressure Study Conducted During NDA Review

Although the US FDA first recommended a dedicated ambulatory blood pressure monitoring study in March 2017, AMAG did not move forward with such a trial until late 2018 and only after the agency said the results were needed prior to approving bremelanotide, the Pink Sheet's latest Drug Review Profile finds.

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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