FDA Adds New Co-Primary Endpoint For Female Sexual Desire Drugs
Draft guidance says 'associated distress' may replace number of satisfying sexual events as a co-primary efficacy endpoint.
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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.
The latest drug development news and highlights from our US FDA Performance Tracker.