Johnson & Johnson’s Caplyta shows greater efficacy in major depressive disorder

Johnson & Johnson announced findings from the first network meta-analysis comparing Caplyta – lumateperone – to FDA-approved atypical antipsychotics for add-on treatment of major depressive disorder, or aMDD, in adults, drawing on data from 10 registrational randomized clinical trials. The NMA found that Caplyta was favored for the efficacy outcomes across four measures, based on indirect comparisons derived from placebo plus antidepressant therapy, or ADT, -controlled trials. The analysis also evaluated safety outcomes, with Caplyta demonstrating no statistically significant weight gain compared to placebo plus ADT and favorable rankings on select tolerability measures. 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% of the population. A supplemental New Drug Application 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 FDA. The medication is also being studied for other neuropsychiatric disorders. Caplyta is not FDA-approved for these disorders.