Johnson & Johnson reports seltorexant met endpoints in MDD3001 clinical trial

Johnson & Johnson announced topline results from the pivotal Phase 3 MDD3001 clinical trial evaluating the efficacy and safety of seltorexant as an adjunctive treatment to baseline antidepressants in adult and elderly patients with major depressive disorder, or MDD, with insomnia symptoms. Seltorexant is an investigational first-in-class selective antagonist of the human orexin-2 receptor being studied for the adjunctive treatment of MDD with insomnia symptoms. The findings will be presented at this year’s American Society of Clinical Psychopharmacology, or ASCP, Annual Meeting, which is being held from May 28-31. The Phase 3 randomized, double-blind, multicenter, placebo-controlled study achieved all primary and secondary endpoints, with seltorexant demonstrating both a statistically significant and clinically meaningful improvement in depressive symptoms based on the Montgomery-Asberg Depression Rating Scale, or MADRS, total score at day 43, and improved sleep disturbance outcomes, in patients who had a prior inadequate response to SSRI/SNRI antidepressants alone. Additional data presented at ASCP includes positive topline results from the placebo-controlled Phase 4 TRD4005 study of SPRAVATO CIII nasal spray as a monotherapy in patients with TRD, which met both its primary and secondary endpoints. The randomized, double-blind, multicenter study showed SPRAVATO provided rapid, statistically significant, and clinically meaningful improvement in depressive symptoms ~24 hours after the first dose and sustained through 4 weeks of treatment, as assessed by changes in MADRS total score, J&J stated.