Benzinga – by Vandana Singh, Benzinga Editor.
Wednesday, Johnson & Johnson (NYSE:JNJ) announced topline results from Phase 3 MDD3001 clinical trial evaluating the efficacy and safety of seltorexant as an adjunctive treatment to baseline antidepressants in adult and elderly patients with major depressive disorder (MDD) with insomnia symptoms.
Seltorexant is an investigational first-in-class selective antagonist of the human orexin-2 receptor being studied for the adjunctive treatment of MDD with insomnia symptoms.
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The findings will be presented at this year’s American Society of Clinical Psychopharmacology (ASCP) Annual Meeting.
The study achieved all primary and secondary endpoints, with seltorexant demonstrating both a statistically significant and clinically meaningful improvement in depressive symptoms and improved sleep disturbance outcomes in patients who had a prior inadequate response to SSRI/SNRI antidepressants alone.
These results were observed in a patient population that was assessed to be moderately to severely depressed despite ongoing treatment with SSRI/SNRIs and suffered from significant sleep disturbance.
Seltorexant was also safe and well-tolerated in the study, with similar rates of common adverse events seen in both trial arms, consistent with previous seltorexant clinical trials.
MDD is one of the most common psychiatric disorders and leading causes of disability worldwide, with an estimated 280 million people living with the disorder around the world.
Approximately 60% of MDD patients experience insomnia symptoms despite being on an SSRI/SNRI.
An estimated 21.0 million adults in the United States had at least one major depressive episode, according to data from NIH.
On Tuesday, Johnson & Johnson agreed to acquire global rights to the bispecific antibody NM26 from Numab Therapeutics in an all-cash transaction of approximately $1.25 billion.
Price Action: JNJ shares are up 0.18% at $144.64 at the last check on Wednesday.
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