Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

J&J’s seltorexant declares positive results from Phase III MDD trial

Johnson & Johnson (J&J) has reported positive results from its Phase III trial of seltorexant in major depressive disorder (MDD), meeting all primary and secondary endpoints. The MDD3001 study investigated seltorexant as an adjunctive treatment to baseline antidepressants in adult and elderly MDD patients with insomnia symptoms. The randomized, double-blind, multicenter, placebo-controlled trial showed significant improvement in depressive symptoms based on the Montgomery-Asberg Depression Rating Scale (MADRS) and sleep disturbance outcomes. Seltorexant was well-tolerated with similar adverse event rates in both groups. MDD often co-occurs with sleep disturbances, affecting around 60% of patients on standard antidepressants. Currently, there are no approved therapies for MDD with insomnia symptoms. Seltorexant, an investigational selective orexin-2 receptor antagonist, shows promise in addressing both mood and sleep symptoms associated with depression.