Intra-Cellular Therapies Submits Supplemental New Drug Application for CAPLYTA

On December 3, 2024, Intra-Cellular Therapies, Inc. (NASDAQ: ITCI) announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for CAPLYTA (lumateperone) for the treatment of Major Depressive Disorder (MDD) as adjunctive therapy to antidepressants. This submission follows positive results from Studies 501 and 502, showcasing CAPLYTA’s robust antidepressant efficacy and favorable safety and tolerability profile.

Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies, emphasized the significance of CAPLYTA in addressing the unmet needs of patients with MDD. CAPLYTA’s adjunctive therapy potential offers hope for patients who do not respond adequately to antidepressants alone.

Studies 501 and 502, pivotal Phase 3 global studies, demonstrated CAPLYTA’s efficacy when added to antidepressants. Notably, CAPLYTA showed marked improvement in the Montgomery Asberg Depression Rating Scale (MADRS) total scores, indicating a significant therapeutic benefit in patients with MDD.

The safety and tolerability profile of CAPLYTA is highlighted by a favorable metabolic, weight, and movement disorder profile. Commonly reported adverse events, such as dizziness, dry mouth, somnolence, nausea, and fatigue, were observed at rates greater than or equal to 5% for lumateperone, with low rates of extrapyramidal symptoms reported.

Major Depressive Disorder affects millions of adults annually, with a substantial portion of patients not achieving remission with standard treatments. CAPLYTA, currently approved for other indications, holds promise as a potential first-line treatment for MDD pending FDA approval.

Intra-Cellular Therapies, leveraging Nobel prize-winning research, continues its commitment to developing innovative therapies for complex psychiatric and neurologic diseases. For more information on Intra-Cellular Therapies and CAPLYTA, visit their website.

This news release contains forward-looking statements, subject to various risks and uncertainties. Intra-Cellular Therapies emphasizes its dedication to providing efficacious treatments while closely monitoring potential challenges and developments.

For additional information, please contact Juan Sanchez, M.D., Vice President of Corporate Communications and Investor Relations at Intra-Cellular Therapies or Cameron Radinovic at Burns McClellan, Inc.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Intra-Cellular Therapies’s 8K filing here.

About Intra-Cellular Therapies

Intra-Cellular Therapies, Inc, a biopharmaceutical company, focuses on the discovery, clinical development, and commercialization of small molecule drugs that address medical needs primarily in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms in the central nervous system (CNS) in the United States.