Johnson & Johnson (J&J) has announced that its seltorexant medication met all the primary and secondary endpoints in a Phase III trial in major depressive disorder (MDD).

The company announced topline results from the MDD3001 study, which is investigating the efficacy and safety of seltorexant as an adjunctive treatment to baseline antidepressants in adult and elderly MDD patients who suffer insomnia symptoms.

The Phase III randomised, double-blind, multicentre, placebo-controlled study achieved all primary and secondary endpoints.

The therapy demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms based on the Montgomery-Asberg Depression Rating Scale (MADRS) and improved sleep disturbance outcomes.

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 trials.

University of California psychiatry professor Andrew Krystal MD said “Seltorexant has the potential to fill a significant unmet need for new therapies to treat patients experiencing depression and insomnia, and most importantly, to improve outcomes and quality of life for these patients.”

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MDD is often accompanied by sleep disturbances such as insomnia or hypersomnia. With insomnia, patients may have trouble falling asleep, staying asleep, or getting good-quality sleep. Approximately 60% of MDD patients on standard-of-care oral antidepressants experience residual insomnia symptoms. Currently, no therapies are approved to treat 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. It acts by selectively antagonising orexin-2 receptors, potentially improving mood and sleep symptoms associated with depression. J&J was previously developing the candidate with biotech Minerva Neurosciences but the company dropped out of the collaboration in 2020.

MDD landscape

MDD is a common psychiatric disease characterised by single or recurrent major depressive episodes. It is a mood disorder that can lead to a variety of emotional and physical problems.

Disease prevalence is high globally, with approximately 350 million people living with the condition worldwide as of 2015, according to a GlobalData report.

The MDD market is a crowded and competitive market with a large number of products available for the treatment of patients, the majority of which are available as inexpensive generics. The MDD therapeutics market is projected to grow to $9.6bn by 2029, driven by an increase in the patient share of recently approved drugs and the anticipated introduction of late-stage pipeline products.

GlobalData is the parent company of the Clinical Trials Arena.