- FDA approved CAPLYTA\u00ae for major depressive disorder as an adjunctive therapy.
- CAPLYTA\u00ae showed significant improvement in depression symptoms in Phase 3 trials.
- The trials demonstrated a large separation in MADRS scores between CAPLYTA\u00ae and placebo.
- CAPLYTA\u00ae does not require dose titration and has a safety profile similar to placebo.
FDA Approval
The FDA has approved CAPLYTA® (lumateperone) as an adjunctive therapy with antidepressants for treating major depressive disorder (MDD) in adults. This marks the first approval under Johnson & Johnson's leadership following its acquisition of Intra-Cellular Therapies, Inc.
Clinical Trials
The approval is based on positive results from two Phase 3, double-blind, placebo-controlled trials, Studies 501 and 502. Both studies met their primary and key secondary endpoints, showing statistically significant and clinically meaningful improvement in depression symptoms compared to an oral antidepressant plus placebo.
Trial Results
In Study 501, a large separation in total MADRS score was observed between CAPLYTA® and placebo (-4.9 points, effect size 0.61), and in Study 502 (-4.5 points, effect size 0.56) at six weeks. Separation from placebo was seen as early as one week in Study 501 and two weeks in Study 502.
Safety Profile
CAPLYTA®'s safety profile was consistent with existing data for its schizophrenia and bipolar depression indications. No new safety concerns were identified, and weight gain and metabolic changes were similar to placebo. Common side effects include sleepiness, dizziness, nausea, dry mouth, feeling tired, and diarrhea.
Long-term Data
Long-term data from the 503 open-label extension safety study showed CAPLYTA® was safe and well-tolerated, with 80% of patients responding to treatment and 65% experiencing remission at six months.
