Neurocrine Biosciences, Inc. announced the initiation of a Phase 3 registrational study to evaluate the efficacy, safety, and tolerability of osavampator (formerly NBI-1065845). This investigational drug is under development as an adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults.
Osavampator has the potential to become a first-in-class treatment for MDD, a disorder that impacts more than 21 million people in the United States, with over a third experiencing debilitating symptoms that current treatments cannot fully resolve. The Phase 2 SAVITRI study with osavampator met its primary and secondary endpoints and was generally well tolerated.
The Phase 3 registrational program is designed to assess osavampator in adult subjects with a primary diagnosis of MDD who have an inadequate response to current antidepressant treatment. This advancement signifies a critical step in addressing a significant unmet medical need.
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