J&J's daily add-on pill improves depression and insomnia symptoms, acing phase 3

Johnson & Johnson’s oral add-on drug significantly improved depressive symptoms and sleep outcomes in a phase 3 trial for patients who previously did not benefit from antidepressants alone.

The top-line results are from a pivotal clinical trial that enrolled 588 adult and elderly patients with major depressive disorder (MDD) and insomnia symptoms. J&J is sharing the findings at this year’s ongoing American Society of Clinical Psychopharmacology Annual Meeting in Florida.

The late-stage study evaluated seltorexant, a selective antagonist of the human orexin-2 receptor, as a daily adjunctive to background SSRI/SNRI antidepressants.

Seltorexant demonstrated a statistically significant improvement in depressive symptoms at day 43 compared to placebo. The investigational drug was also tied to improved sleep disturbance outcomes and was found to be safe and well-tolerated.

The trial achieved all 15 primary and 10 secondary endpoints, according to J&J.

“Depression is a leading cause of disability worldwide and shares a strong link with sleep disturbances,” Andrew Krystal, M.D., psychiatry professor at the University of California, San Francisco Weill Institute for Neurosciences, said in a May 29 release. “In MDD, insomnia symptoms exacerbate the risk of depressive relapse, increase healthcare costs and impact quality of life, and it often goes under-treated despite being one of the most common residual symptoms.”

Currently, no approved therapies exist for treating MDD with insomnia symptoms.