Johnson & Johnson Presents Phase 3 Data for Seltorexant in Major Depressive Disorder at 2025 Psych Congress
核心洞察
Johnson & Johnson will present 21 abstracts at the 2025 Psych Congress, featuring new Phase 3 data demonstrating the safety and efficacy of investigational seltorexant compared to quetiapine XR in major depressive disorder (搜索) with insomnia (搜索) symptoms.
The presentations include post-hoc analyses of CAPLYTA for MDD patients with anxious distress and SPRAVATO monotherapy effects on anhedonia and emotional blunting in treatment-resistant depression (搜索).
Major depressive disorder (搜索) affects approximately 332 million people worldwide, with about 60 percent of MDD patients experiencing insomnia (搜索) symptoms despite standard antidepressant treatment.
Johnson & Johnson announced that 21 abstracts featuring new real-world and clinical trial data will be presented at the annual U.S. Psychiatric and Mental Health Congress (Psych Congress), taking place September 17 to 21 in San Diego, California. The presentations showcase research from across the company's neuropsychiatry portfolio, including major depressive disorder (搜索) (MDD), treatment-resistant depression (搜索) (TRD), and schizophrenia (搜索).
"As the global leader in neuropsychiatry, we're harnessing decades of knowledge and expertise to redefine what's possible for people living with neuropsychiatric disorders," said Bill Martin, Ph.D., Global Neuroscience Therapeutic Area Head, Johnson & Johnson Innovative Medicine.
Phase 3 Seltorexant Data Highlights
The key presentation features new data from a Phase 3 head-to-head study evaluating the safety and efficacy of seltorexant, an investigational first-in-class therapy, in combination with an oral antidepressant compared to adjunctive quetiapine extended release (XR) in MDD with insomnia (搜索) symptoms.
Seltorexant is a selective antagonist of the human orexin-2 receptor (搜索) currently being developed as an adjunctive treatment for adults with MDD with insomnia (搜索) symptoms. The investigational therapy selectively antagonizes orexin-2 receptors, potentially improving mood symptoms and restoring sleep without next-day sedation in patients with depression.
When orexin-2 receptors are stimulated for too long or at inappropriate times, their activation can cause hyperarousal manifestations, including insomnia (搜索) and excessive cortisol release, which may contribute to depression and insomnia. Seltorexant is the only investigational therapy being studied in MDD that is believed to work by normalizing the overactivation of the orexin-2 receptors, thereby addressing the underlying biology that contributes to depression and causes insomnia symptoms.
Additional Key Presentations
Other notable presentations include results from a post-hoc analysis of a Phase 3 study evaluating the efficacy of adjunctive CAPLYTA in MDD patients who also met DSM-5 criteria for anxious distress. Data from post-hoc analyses will also evaluate the effect of SPRAVATO as a monotherapy on anhedonia symptoms and emotional blunting in adults with TRD.
Major Depressive Disorder Burden
MDD is one of the most common psychiatric disorders and a leading cause of disability worldwide, impacting an estimated 332 million people—or about 5 percent of the population. In 2021, approximately 21 million adults in the U.S. had at least one major depressive episode.
MDD is a complex, heterogeneous disorder involving multiple regions of the brain and presenting with as many as 256 unique symptom combinations. As a result, responses to treatment vary widely. With current standard-of-care oral antidepressants, 2 in 3 people living with MDD continue to experience residual or persistent symptoms.
MDD is often accompanied by sleep disturbances such as insomnia (搜索) or hypersomnia, with approximately 60 percent of MDD patients experiencing insomnia symptoms despite being on standard-of-care oral antidepressants. Disturbed sleep and insomnia symptoms have a significant impact on a patient's quality of life and exacerbate the risk of depressive relapse and suicide.
Treatment-Resistant Depression Challenge
Approximately one-third of adults with MDD will not respond to oral antidepressants alone and are considered to have treatment-resistant depression (搜索) (TRD), which is often defined as inadequate response to two or more oral antidepressants that were administered at an adequate dose for an adequate duration. TRD has a significant negative impact on the lives of those affected and has one of the highest economic burdens of all psychiatric disorders.
Patients often cycle through multiple oral medications, waiting 4-6 weeks for potential relief. Based on the STAR*d study after trying their third oral antidepressant, approximately 86 percent of patients do not achieve remission.
Company Portfolio Updates
CAPLYTA is approved by the U.S. FDA for the treatment of adults with schizophrenia (搜索), as well as depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy, and as adjunctive therapy with lithium or valproate. A supplemental new drug application (sNDA) for CAPLYTA as an adjunctive treatment for adults with major depressive disorder (搜索) is currently under U.S. Food and Drug Administration review.
SPRAVATO (esketamine) CIII nasal spray is approved by the U.S. Food and Drug Administration alone or in conjunction with an oral antidepressant for adults with MDD when they have inadequate response to at least two oral antidepressants (TRD) and depressive symptoms in adults with major depressive disorder (搜索) with acute suicidal ideation or behavior in conjunction with an oral antidepressant. To date, SPRAVATO has been approved in 79 markets and administered to more than 150,000 patients worldwide.
"A staggering one in eight people worldwide are living with a mental health disorder," said Tyrone Brewer, President, U.S. Neuroscience, Johnson & Johnson Innovative Medicine. "At Johnson & Johnson, we are unwavering in our commitment to deliver a portfolio of differentiated and impactful solutions that confront neuroscience's toughest challenges."