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Johnson & Johnson announced today that the topline results of the Phase 3 clinical trial MDD3001 showed that seltorexant, as an adjunctive treatment for antidepressants, demonstrated efficacy and safety in adult and elderly patients with major depressive disorder (MDD) accompanied by insomnia symptoms.Seltorexant is a potential "first-in-class" selective human orexin-2 receptor antagonist.

Seltorexant is an antidepressant therapy for the treatment of MDD co-developed by Johnson & Johnson and Minerva Neurosciences. It is a potential "first-in-class" oral, specific orexin-2 receptor antagonist. The orexin system in the brain is associated with metabolism, stress response, and maintaining wakefulness.Seltorexant can suppress the hyperarousal symptoms observed in patients with depression by inhibiting the orexin-2 receptor.

In addition, Johnson & Johnson announced the results of Spravato nasal spray as a monotherapy in the Phase 4 clinical trial TRD4005 for patients with treatment-resistant depression (TRD). The study met its primary and secondary endpoints. This randomized, double-blind, multicenter study showed,Spravato provided rapid, statistically significant, and clinically meaningful improvement in depressive symptoms approximately 24 hours after the first dose, and continued to be effective throughout the 4-week treatment period.
Spravato has been approved by the U.S. FDA for use in combination with oral antidepressants to treat adult patients with treatment-resistant depression and adults with major depressive disorder accompanied by suicidal thoughts or behaviors.

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