Johnson & Johnson pivotal study of Seltorexant shows statistically significant and clinically meaningful improvement in depressive symptoms and sleep disturbance outcomes. Seltorexant meets all primary and secondary endpoints in the pivotal Phase 3 MDD3001 clinical trial of adult and elderly patients with major depressive disorder (MDD) with insomnia symptoms.
Orexin signaling pathways are found to be associated with depression and anxiety. Orexin neurons receive and transmit signals throughout the central nervous system (CNS) that are modulated by their specific receptors (OX1R, OX2R). Seltorexant is an investigational first-in-class selective antagonist of ORX2 receptor. It is developed as an adjunctive therapy for MDD and for the treatment of insomnia disorder.