Neurocrine Biosciences Unveils Phase 3 Trial for Osavampator in MDD Treatment

Neurocrine Biosciences, Inc., a prominent biopharmaceutical firm concentrating on neuroscience, revealed the commencement of a phase 3 trial to assess the efficacy, safety, and tolerability of osavampator (previously known as NBI-1065845), a candidate medication being developed as an additional treatment alongside antidepressants for major depressive disorder (MDD). In April 2024, positive topline results for the phase 2 SAVITRI study of osavampator in adult patients with MDD were revealed.

"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," said Eiry W. Roberts, M.D., chief medical officer at Neurocrine Biosciences. "More than a third of those MDD sufferers endure debilitating symptoms that current treatment options cannot fully resolve."

The phase 2 SAVITRI trial utilizing osavampator achieved its main and secondary goals and was overall well accepted.

"Major depressive disorder is a condition that has a profound effect on patients and their families and is associated with significant morbidity and mortality," said Maurizio Fava, M.D., Chair, Mass General Brigham Academic Medical Centers Department of Psychiatry. "The great majority of patients suffering from major depressive disorder do not achieve a sustained remission of their condition and the options for next step strategies to help them are quite limited. This trial is happening at a time when it is clear that, as a field, we need to develop new augmentation strategies to enhance the efficacy of standard antidepressants."