Neurocrine’s NBI-1065845 shows efficacy in major depressive disorder

Neurocrine announced positive topline data for its Phase 2 SAVITRI study. This dose-finding study assessed the efficacy and safety of NBI-1065845 in adult subjects with major depressive disorder – MDD -. The study met its primary and key secondary endpoints, demonstrating that once-daily, oral administration of NBI-1065845 produced a statistically significant change from baseline in MADRS total score at both Day 28 and Day 56. NBI-1065845 was generally well tolerated. The most common adverse event was headache. The adverse event profile for both doses of NBI-1065845 were comparable to placebo. There were no deaths or serious adverse events. The discontinuation rates were low throughout the study. The company expects to meet with the FDA to discuss a path into Phase 3 studies.