J&J depression drug succeeds in late-stage trial

Johnson & Johnson's innovative therapy, seltorexant, has shown promising results in a crucial phase 3 study for patients suffering from major depressive disorder (MDD) with insomnia symptoms. The MDD3001 clinical trial aimed to assess the effectiveness and safety of seltorexant when used in combination with existing antidepressants in both adult and elderly patients who displayed symptoms of MDD and insomnia.

The findings from this trial were significant. Seltorexant not only met all primary and secondary endpoints but also demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms. This improvement was measured using the Montgomery-Asberg Depression Rating Scale total score at day 43. Additionally, patients exhibited enhanced sleep disturbance outcomes. These results were particularly important for patients who had previously shown an inadequate response to selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) alone.

Currently, there is no approved therapy specifically targeting MDD with insomnia symptoms. This gap in treatment is critical as approximately 60% of MDD patients on standard oral antidepressants experience residual insomnia symptoms, according to Johnson & Johnson. Seltorexant works by selectively antagonizing the orexin-2 receptors, which has the potential to improve both mood and sleep symptoms that are often associated with depression.

In addition to the progress with seltorexant, Johnson & Johnson also announced favorable results from a post-marketing surveillance study of its esketamine nasal spray, Spravato. This study evaluated Spravato as a monotherapy in patients with treatment-resistant depression. Spravato gained approval in 2019, marking the first new drug approved for depression in over 30 years when it was authorized for use alongside an oral antidepressant to treat treatment-resistant depression. By 2020, it was also approved as an add-on treatment for MDD with acute suicidal ideation and behavior.

These advancements represent significant steps forward in the treatment of depression and related symptoms. The positive outcomes from the seltorexant trial and the continued success of Spravato highlight Johnson & Johnson's commitment to addressing the complex needs of patients with depressive disorders. The company’s focus on developing therapies that address both mood and sleep disturbances could potentially offer more comprehensive treatment options for individuals suffering from MDD.