J&J's daily pill enhances depression and insomnia in phase 3

Johnson & Johnson has reported promising results from a phase 3 clinical trial for their oral add-on medication aimed at addressing major depressive disorder (MDD) with concurrent insomnia symptoms. This medication, known as seltorexant, has shown significant improvement in both depressive symptoms and sleep outcomes for patients who had not responded to antidepressants alone.

The clinical trial involved 588 adult and elderly participants diagnosed with MDD and insomnia symptoms. The data were shared during the American Society of Clinical Psychopharmacology Annual Meeting in Florida. Seltorexant operates as a selective antagonist of the human orexin-2 receptor and was tested as an adjunct therapy alongside existing SSRI/SNRI antidepressants.

On the 43rd day of the trial, seltorexant demonstrated a statistically significant reduction in depressive symptoms compared to placebo. Additionally, it showed notable improvements in sleep disturbance outcomes. The drug was also deemed safe and well-tolerated by the patients.

Johnson & Johnson reported that the trial met all 15 primary and 10 secondary endpoints, indicating robust efficacy across multiple measures. Dr. Andrew Krystal, a professor of psychiatry at the University of California, San Francisco Weill Institute for Neurosciences, emphasized the importance of these findings. He noted that depression is a leading cause of disability worldwide and is strongly associated with sleep disturbances. He highlighted that in MDD, insomnia can exacerbate depressive relapse, increase healthcare costs, and severely impact quality of life. Despite these issues, insomnia often remains inadequately treated among patients with MDD.

At present, there are no approved therapies specifically for treating MDD with insomnia symptoms, making these findings particularly significant. The success of seltorexant in this clinical trial may pave the way for new therapeutic options that address this critical unmet need in mental health treatment.