J&J depression drug aces late-stage trial
30 May 2024
Clinical ResultPhase 3Drug Approval
Johnson & Johnson's investigational first-in-class therapy, seltorexant, met all primary and secondary endpoints in a pivotal phase 3 study in patients with major depressive disorder (MDD) with insomnia symptoms.
The MDD3001 clinical trial evaluated the efficacy and safety of seltorexant as an adjunctive treatment to baseline antidepressants in adult and elderly patients with MDD with insomnia symptoms. In the trial, seltorexant demonstrated both a statistically significant and clinically meaningful improvement in depressive symptoms based on the Montgomery-Asberg Depression Rating Scale total score at day 43, and improved sleep disturbance outcomes, in patients who had a prior inadequate response to SSRI/SNRI antidepressants alone.
Currently, no therapies are approved to treat MDD with insomnia symptoms. According to J&J, approximately 60% of MDD patients on standard-of-care oral antidepressants experience residual insomnia symptoms. Seltorexant selectively antagonizes the orexin-2 receptors, potentially improving mood and sleep symptoms associated with depression.
At the same time, J&J also reported positive topline results from a post-marketing surveillance study of its esketamine nasal spray, Spravato, as a monotherapy in patients with treatment-resistant depression. In 2019, Spravato became the first new drug approved to treat depression in more than 30 years when it was approved in conjunction with an oral antidepressant for treatment-resistant depression. A year later, it was approved for use as an add-on to treat MDD with acute suicidal ideation and behavior.
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