What's Happening?
Neurocrine Biosciences has announced promising results from its Phase 2 SAVITRI study of osavampator, a potential adjunctive treatment for adults with major depressive disorder (MDD). The study involved 183 adults who were randomized to receive either a placebo or osavampator at doses of 1 mg or 3 mg daily for eight weeks. The results showed statistically significant improvements in depression severity at both Day 28 and Day 56, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). Osavampator was well tolerated, with no serious adverse events reported. The study's findings were presented at the 38th annual Psych Congress, where Neurocrine received the 2025 Poster Award.
Why It's Important?
Major depressive disorder affects over 21 million people in the U.S., with many patients not achieving adequate relief from existing treatments. The positive results from Neurocrine's study suggest that osavampator could offer a new therapeutic option for those with MDD who do not respond well to current antidepressants. This development could significantly impact the mental health treatment landscape, providing hope for improved outcomes for patients struggling with depression. The study's success also reinforces Neurocrine's position as a leader in neuroscience-focused biopharmaceuticals.
What's Next?
Following the successful Phase 2 results, Neurocrine has initiated a Phase 3 registrational program for osavampator, which includes five active studies currently enrolling participants. These studies aim to further evaluate the efficacy and safety of osavampator in a larger population, potentially leading to regulatory approval and commercialization. The continued development of osavampator could pave the way for its use as a standard adjunctive treatment for MDD, pending positive outcomes in Phase 3 trials.
