Neurocrine Biosciences, Inc. (NBIX), a neuroscience-focused, biopharmaceutical company, on Tuesday announced the initiation of a Phase 3 registrational study to evaluate the efficacy, safety, and tolerability of Osavampator as an adjunctive treatment to antidepressants for patients with major depressive disorder or MDD. The company previously shared positive topline data from its Phase 2 SAVITRI study, which demonstrated that osavampator met its primary and secondary endpoints and was well-tolerated by adult subjects with MDD.
Osavampator, a potential first-in-class drug, is an AMPA positive allosteric modulator or PAM that targets patients with inadequate responses to existing antidepressant treatments.
MDD is a major public health issue, affecting over 21 million people in the U.S., with a significant portion of patients suffering from symptoms that current therapies cannot fully resolve.
The Phase 3 study aims to build on the promising Phase 2 results and will enroll adults with MDD who have not responded adequately to current treatments.
Neurocrine's Chief Medical Officer, Dr. Eiry W. Roberts, expressed that osavampator holds great potential as a groundbreaking treatment for MDD. This new study is critical for advancing the drug's development to meet the needs of those living with severe, treatment-resistant depression.
The company believes that the completion of the Phase 3 registrational program will pave the way for osavampator to become a vital option in the treatment of MDD.
Currently, NBIX is trading at $148.99 up by 0.09%.
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