J&J pivotal study: Seltorexant shows significant improvement in depression and sleep outcomes

Johnson & Johnson recently released positive results from their Phase 3 MDD3001 study, showcasing the efficacy of seltorexant as an additional treatment for major depressive disorder (MDD) patients suffering from insomnia. Seltorexant, a novel selective antagonist of the human orexin-2 receptor, showed significant promise in improving both depressive and insomnia symptoms among adult and elderly patients. The findings are to be presented at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami.

The double-blind, multicenter study achieved all its primary and secondary endpoints. Patients showed statistically significant improvements in depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) within 43 days. The study also noted enhanced sleep quality in patients who had not responded adequately to standard SSRI/SNRI antidepressants. Importantly, seltorexant was well-tolerated with similar adverse event rates in the treatment and placebo groups.

The Unmet Need in MDD Treatment

Depression significantly impacts global health, often accompanied by sleep disturbances like insomnia, which affects about 60% of MDD patients on conventional antidepressants. Insomnia exacerbates depressive symptoms, increasing healthcare costs and reducing quality of life. Despite its prevalence, there are no approved therapies specifically targeting MDD with insomnia symptoms.

Expert Opinions

Dr. Andrew Krystal, a psychiatry professor at the University of California, San Francisco, emphasized the potential of seltorexant to address the unmet needs in treating depression with insomnia. According to Dr. Krystal, insomnia in MDD contributes to higher relapse rates and poorer quality of life, underscoring the need for innovative treatments like seltorexant.

SPRAVATO®: A Breakthrough for Treatment-Resistant Depression

In addition to seltorexant, Johnson & Johnson also revealed positive topline results for SPRAVATO® (esketamine) nasal spray in the Phase 4 TRD4005 study. SPRAVATO® demonstrated rapid and sustained efficacy as a monotherapy for treatment-resistant depression (TRD). The double-blind, placebo-controlled study found that SPRAVATO® significantly improved depressive symptoms within 24 hours of the first dose, with effects sustained over four weeks.

About SPRAVATO®

SPRAVATO® is approved by the U.S. FDA for use alongside an oral antidepressant for adults with TRD and for depressive symptoms in MDD patients with suicidal thoughts or behaviors. Since its 2019 approval, SPRAVATO® has been administered to over 100,000 patients globally, representing a novel mechanism of action in MDD treatment.

The safety profile of SPRAVATO® in this study was consistent with previous Phase 3 trials, showing no new safety concerns. The rapid onset of action and sustained efficacy make SPRAVATO® a valuable addition to the treatment landscape for TRD.

Conclusion

Johnson & Johnson's recent findings offer hope for improving the management of MDD with insomnia and TRD. Seltorexant’s promising results in Phase 3 trials and SPRAVATO®'s demonstrated efficacy highlight the company's commitment to addressing the complex needs of depression patients. As global leaders in mental health treatment, Johnson & Johnson continues to innovate, aiming to enhance patient outcomes and quality of life.

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