Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved CAPLYTA (lumateperone) as an adjunctive therapy with antidepressants for adults with major depressive disorder (MDD). This marks the first FDA approval under Johnson & Johnson's leadership following its acquisition of Intra-Cellular Therapies, Inc.
CAPLYTA is now indicated as an add-on treatment for MDD in adults, providing a new option for patients who continue to experience symptoms despite standard antidepressant therapy. According to the company, CAPLYTA does not require titration and its side effects related to weight gain and metabolism are similar to those observed with placebo.
“Depression is a complex disorder that affects each person differently, underscoring the urgent need for a range of effective and well-tolerated treatment options,” said Roger S. McIntyre, M.D., FRCPC, Professor of Psychiatry and Pharmacology at the University of Toronto. “For people who are still experiencing lingering depressive symptoms while on an antidepressant, adding CAPLYTA to a patient’s treatment regimen may offer early improvement, with the potential for remission—the ultimate goal of treatment.”
The approval is based on results from two Phase 3 global studies—Study 501 and Study 502—which showed statistically significant improvements in depression symptoms compared to placebo when added to ongoing antidepressant therapy. In both studies, separation from placebo was seen within one or two weeks and sustained through six weeks.
The safety profile observed in these trials was consistent with previous data from CAPLYTA’s use in schizophrenia and bipolar depression indications. No new safety concerns were identified during clinical testing.
Michael Pollock, CEO of Depression and Bipolar Support Alliance (DBSA), commented: “Major depressive disorder affects millions of Americans, impacting how a person feels, thinks, and acts. DBSA believes that all individuals have the right to direct their own treatment, and we understand that for many people, ongoing antidepressant therapy alone may not offer meaningful relief. The introduction of new treatment options, and continued innovation in mental health, has enabled us to reset expectations for living with depression and offers people hope that achieving lasting wellness and remission is possible.”
Long-term data from Study 503 showed that CAPLYTA remained safe over 26 weeks; most patients responded positively or achieved remission by six months.
Bill Martin, Ph.D., Global Therapeutic Area Head for Neuroscience at Johnson & Johnson Innovative Medicine stated: “CAPLYTAhas the potential to become a new standard of care across multiple mental health disorders, including major depressive disorder. This approval is a testament to our nearly 70-year commitment of bringing innovative and differentiated therapies that redefine treatment expectations—and introduce the possibility of remission—to patients living with some of today’s most prevalent and debilitating mental health conditions.”
Major depressive disorder remains one of the most common psychiatric disorders globally. It affects about 332 million people worldwide—about four percent of the population—and around 22 million adults in the United States according to recent World Health Organization estimates (https://www.who.int/news-room/fact-sheets/detail/depression) as well as data from U.S. government sources (https://www.samhsa.gov/data/sites/default/files/reports/rpt47095/National%20Report/National%20Report/2023-nsduh-annual-national.pdf). Many patients do not achieve full relief from symptoms using oral antidepressants alone.
Johnson & Johnson noted that it recently submitted additional applications to expand CAPLYTA’s uses further but emphasized these are still under review by regulatory authorities.
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