Neurocrine’s Osavampator Shows Strong Efficacy and Safety in Phase II MDD Trial

Neurocrine Biosciences’ osavampator demonstrated positive results in the Phase II SAVITRI trial for major depressive disorder (MDD), meeting both primary and secondary endpoints while showing a favorable safety profile. In the study (NCT05203341), a 1mg dose produced a statistically significant 4.3-point placebo-adjusted reduction in depression scores at 28 days, deepening to a 7.5-point drop on the MADRS scale by day 56. Nearly 49% of patients achieved remission, defined as a MADRS score of 10 or lower. The 3mg arm showed less pronounced improvements. Osavampator, an AMPA receptor positive allosteric modulator, avoided severe treatment-emergent adverse events, with mostly mild headaches or nasal inflammation. The trial’s success supports Neurocrine’s ongoing Phase III program, targeting patients unresponsive to oral antidepressants. Analysts note its novel mechanism of action and favorable tolerability may position osavampator as an attractive adjunctive therapy, potentially offering an alternative to atypical antipsychotics with fewer side effects.

27-09-2025