Seltorexant's Positive Phase III Results for Treating Major Depressive Disorder with Insomnia

Seltorexant's Positive Phase III Results for Treating Major Depressive Disorder with Insomnia

Maria Blanco
2 min read

Johnson & Johnson's Seltorexant Shows Promise in Treating Major Depressive Disorder with Insomnia

Johnson & Johnson has reported positive outcomes from a Phase III trial of seltorexant, indicating its effectiveness in treating major depressive disorder (MDD) accompanied by insomnia symptoms. The trial, encompassing both adult and elderly patients, exhibited significant enhancements in depressive symptoms and sleep disturbances, as gauged by the Montgomery-Asberg Depression Rating Scale. Seltorexant, functioning as an orexin-2 receptor antagonist, demonstrated safety and tolerability, with comparable adverse event rates to the placebo. This advancement has the potential to address a substantial unmet need for MDD patients enduring insomnia, ultimately enhancing their quality of life.

Key Takeaways

  • Seltorexant achieved primary and secondary endpoints in the Phase III trial for major depressive disorder (MDD).
  • The trial revealed notable improvements in depressive symptoms and sleep disturbance outcomes.
  • Seltorexant exhibited safety and tolerability, with similar adverse event rates in both trial arms.
  • About 60% of MDD patients confront residual insomnia symptoms that are currently unaddressed by approved therapies.
  • The market for MDD therapeutics is estimated to expand to $9.6 billion by 2029.


The successful Phase III trial of seltorexant by Johnson & Johnson for MDD with insomnia may reshape the landscape of mental health treatment. This milestone confronts a prevalent yet underserved condition affecting 60% of MDD patients, offering the promise of an improved quality of life. The favorable trial outcomes could expedite FDA approval, amplifying J&J's market share and potentially influencing the $9.6 billion MDD therapeutics market by 2029. Investors and competitors are monitoring regulatory and commercial advancements closely since the success of seltorexant could redefine treatment standards and investment opportunities in psychiatric pharmaceuticals.

Did You Know?

  • Seltorexant: A selective orexin-2 receptor antagonist engineered for treating insomnia and depression. It operates by obstructing the action of orexins, regulating wakefulness and arousal, thereby promoting sleep and potentially alleviating depressive symptoms.
  • Montgomery-Asberg Depression Rating Scale (MADRS): A clinician-administered diagnostic tool utilized to assess the severity of depressive episodes in patients. It comprises 10 items, each evaluating specific symptoms of depression such as sadness, guilt feelings, and suicidal thoughts, with scores indicating the severity of each symptom.
  • Orexin-2 Receptor: A G-protein coupled receptor that is part of the orexin system, crucial in regulating sleep and wakefulness. Drugs such as seltorexant target the orexin system to address sleep disorders and potentially other conditions like depression by modulating the balance between sleep and wake states.

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