Esketamine Hydrochloride

First presentation of pivotal Phase 3 CAPLYTA ® data in adults with bipolar mania underscores the asset's potential across mood disorders New SPRAVATO ® analyses and schizophrenia research emphasize a focus on complex, high-burden neuropsychiatric conditions Sept. 8, 2026 -- Johnson & Johnson (NYSE: JNJ) today announced that 24 abstracts featuring clinical data and real-world evidence across the neuropsychiatry portfolio will be presented at the 2026 Psych Congress Annual Meeting (September 15-19, New Orleans, LA). Among the featured presentations are new pivotal Phase 3 data evaluating the efficacy and safety of CAPLYTA® (lumateperone) in bipolar mania, alongside additional CAPLYTA® data across bipolar depression and major depressive disorder that further reinforce the breadth of studies for the asset across mood disorders. Data evaluating the effect of SPRAVATO® (esketamine) CIII nasal spray on depressive symptoms such as anhedonia, and Phase 3 clinical trial data for seltorexant in major depressive disorder (MDD) with insomnia symptoms will also be presented. Together, the presentations reflect the Company's continued commitment to advancing research across mood disorders, with a focus on areas where patients and clinicians still face significant treatment challenges. "People living with neuropsychiatric disorders often face complex, overlapping symptoms that can make identification, treatment selection and long-term management especially challenging," said Jane Tiller, MD, Vice President, Global Head of Development, Neuroscience, Johnson & Johnson. "By advancing clinical and real-world evidence across our portfolio and pipeline, we aim to help move psychiatry forward so that clinicians can continue to make more informed decisions for the patients they serve." CAPLYTA® New data from a pivotal Phase 3 study investigating CAPLYTA® in the acute treatment of patients with manic episodes or manic episodes with mixed features associated with bipolar I disorder will be presented,1 alongside additional data evaluating adjunctive CAPLYTA® in MDD across depressive symptoms, remission, patient subgroups, and metabolic outcomes.2-8 New real-world evidence study evaluating treatment patterns among patients with bipolar depression receiving CAPLYTA®, including dosing and duration in line with routine clinical practice.9 SPRAVATO® New analyses examining real-world evidence on the impact of SPRAVATO® in treating anhedonia, a core symptom of depression associated with poorer treatment outcomes.10,11 Long-acting Injectables (LAIs) Real-world studies evaluating schizophrenia-related hospitalizations in young dual-eligible patients prior to LAI initiation and subsequent risk of relapse, as well as treatment satisfaction with LAIs.12,13 Seltorexant Real-world data providing insights into MDD with insomnia symptoms, including disease burden, patient management and treatment outcomes.14-16 The full list of Johnson & Johnson data presentations at Psych Congress is available on JNJ.com. The Company will also support a variety of educational programs, in-booth presentations and training opportunities for attendees, including interactive visualizations of PRIDE LAI data, and the latest CAPLYTA® schizophrenia and network meta-analysis (NMA) findings. Bipolar disorder affects an estimated 37 million people worldwide—approximately 1 in 200 individuals—with 4.4% of U.S. adults experiencing the condition in their lifetime.17,18 Mania, a key feature of Bipolar I disorder, is characterized by at least a week-long period of elevated or irritable mood and/or increased energy, as well as symptoms including grandiosity, decreased need for sleep, racing thoughts, distractibility, and risk-taking behavior.19 These noticeable behavioral changes often differ markedly from an individual's baseline and are frequently first recognized by those close to them. In severe cases, manic episodes may require hospitalization for safety and treatment.20 MDD is one of the most common psychiatric disorders and a leading cause of disability worldwide, impacting an estimated 332 million people—or about 4 percent of the population.21,22,23 In 2023, approximately 22 million adults in the U.S. had at least one major depressive episode.24 While depression is typically treated with a "one-size-fits-all" approach, no two cases are the same. 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.25,26 Only 1 in 3 patients reach remission with their first antidepressant—and rates continue to decline further with each subsequent treatment, leaving many to spend years cycling through multiple treatments trying to find complete, sustained symptom relief.27 Moreover, MDD is a risk factor for the development and worsening of a range of comorbidities, illustrating the importance of integrating mental and general health care.28 Anhedonia, a loss of interest or pleasure in previously enjoyed activities, is one of two defining symptoms of a major depressive episode.29 Anhedonia is associated with poorer treatment outcomes, including lower remission rates, greater functional impairment, and higher suicide risk.30 Notably, 40-70% of people with MDD experience anhedonia.30 MDD often includes sleep disturbances such as insomnia or hypersomnia, with approximately 60 percent of MDD patients experiencing clinically relevant insomnia symptoms despite being on an SSRI/SNRI.31 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.32,33 Approximately one-third of adults with MDD will not respond to oral antidepressants alone and are considered to have treatment-resistant depression (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.34,35 TRD has a significant negative impact on the lives of those affected and has one of the highest economic burdens of all psychiatric disorders.35 Patients often cycle through multiple oral medications, waiting 4-6 weeks for potential relief.36 Based on the STAR*D study, after their third line of treatment, approximately 86 percent of patients do not achieve remission.36 Schizophrenia is a complex, chronic brain disorder that affects how people think, feel, speak, and act. It affects up to an estimated 2.8 million adults in the United States yet remains widely misunderstood and insufficiently treated.37 Symptoms vary by person, but confusion and distortions in perceptions, emotions, and behavior are common.38 Evidence shows that the first three to five years after diagnosis — "the critical period" — from symptom onset are key for a patient's treatment, as this is when the condition progresses most rapidly.39,40 A comprehensive treatment plan, which may include medication, therapy, and psychosocial services, is critical in delaying the time to relapse for adults with schizophrenia.41 CAPLYTA® 42 mg is an oral, once daily atypical antipsychotic approved in adults as an adjunctive therapy with antidepressants for major depressive disorder (MDD), schizophrenia, and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy, or as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA® is unknown, the efficacy of CAPLYTA® could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and partial agonist activity at central dopamine D2 receptors. A supplemental New Drug Application (sNDA) for CAPLYTA® with long-term data evaluating the safety and efficacy of the medication for delayed time to relapse in schizophrenia was recently approved by the U.S. Food and Drug Administration. The medication is also being studied for other neuropsychiatric disorders. CAPLYTA® is not FDA-approved for these disorders. SPRAVATO® is approved by the U.S. Food and Drug Administration as monotherapy 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 with acute suicidal ideation or behavior in conjunction with an oral antidepressant. It is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor and is believed to work differently than traditional antidepressants by acting on a pathway in the brain that affects glutamate. The mechanism by which esketamine exerts its antidepressant effect is unknown. To date, SPRAVATO® has been approved in over 70 markets and administered to more than 250,000 patients worldwide. Johnson & Johnson's portfolio of long-acting injectable (LAI) offerings for schizophrenia offers a varied range of dosing options and the longest-lasting schizophrenia treatments with each dose available, including INVEGA SUSTENNA® (1-month paliperidone palmitate), INVEGA TRINZA® (3-month paliperidone palmitate), and INVEGA HAFYERA® (6-month paliperidone palmitate), all of which are administered in a clinical setting by a medical professional.42,43,44 Seltorexant, an investigational first-in-class therapy, is a selective antagonist of the human orexin-2 receptor currently being developed as an adjunctive treatment for adults with MDD with insomnia symptoms. Seltorexant selectively antagonizes the orexin-2 receptors, potentially improving mood symptoms associated with depression and restoring sleep without next-day sedation.45 When orexin-2 receptors are stimulated for too long or at inappropriate times, their activation can cause hyperarousal manifestations, including insomnia and excessive cortisol release, which may contribute to depression.46,47 Seltorexant is the only investigational therapy under study for the treatment of MDD that is believed to work by normalizing the overactivation of the orexin-2 receptors, thereby targeting the underlying biology that contributes to depression and insomnia symptoms. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. The content above comes from the network. if any infringement, please contact us to modify.