Johnson & Johnson (NYSE:JNJ) has announced positive topline results from the pivotal late-stage MDD3001 study, which assessed the efficacy of its investigational oral drug seltorexant in patients suffering from major depressive disorder (MDD) accompanied by insomnia symptoms.

Study Highlights

Objective: The MDD3001 study aimed to evaluate seltorexant as an adjunctive treatment to baseline antidepressants in adult and elderly patients who did not benefit from antidepressants alone.

Results: The study met all its primary and secondary endpoints.

Outcomes: Treatment with seltorexant showed statistically significant and clinically meaningful improvements in depressive symptoms by day 43 compared to a placebo. Patients also reported better sleep outcomes.

Significance of the Findings

MDD is a prevalent psychiatric disorder and the leading cause of disability globally. It often co-occurs with sleep disturbances like insomnia or hypersomnia, which can exacerbate the risk of depressive relapse and suicide. According to Johnson & Johnson, nearly 60% of MDD patients experience insomnia despite treatment with SSRI/SNRI antidepressants. Currently, no therapies specifically target MDD with insomnia symptoms.

Mechanism of Action

Seltorexant is designed to target the human orexin-2 receptor, showing potential to improve both mood and sleep symptoms associated with depression. If approved, it would introduce a novel mechanism of action for treating MDD patients.

Market Performance

Year to date, Johnson & Johnson’s shares have declined 7.9%, compared to the industry’s 14.7% growth.

Additional Study Results

In addition to the MDD3001 study, Johnson & Johnson provided data from the phase IV TRD4005 study. This study evaluated the efficacy of its depression nasal spray Spravato as a monotherapy in patients with treatment-resistant depression (TRD). The TRD4005 study also met its primary and secondary endpoints, demonstrating rapid and sustained efficacy in TRD patients.

FDA Approval and Presentation

Spravato is currently approved by the FDA, in combination with an oral antidepressant, for treating adults with TRD and depressive symptoms in adults with MDD accompanied by suicidal thoughts or behaviors.

Johnson & Johnson presented the results from both studies at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting.

This breakthrough in seltorexant’s development could offer a new therapeutic option for patients struggling with MDD and insomnia, potentially transforming the treatment landscape for this challenging condition.

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