FDA Approves CAPLYTA as Adjunctive Therapy for Major Depressive Disorder; Phase 3 MADRS Separations of 4.9 and 4.5 Points
Johnson & Johnson announced on November 6 that the U.S. Food and Drug Administration (FDA) has approved CAPLYTA (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. It is the fourth approved indication for CAPLYTA, which was previously approved for schizophrenia in adults and for depressive episodes associated with bipolar I or II disorder. Johnson & Johnson said it is the first approval under its leadership following its acquisition of Intra-Cellular Therapies, and that treatment starts at the effective 42 mg dose with no titration needed.
The approval rests on two global Phase 3 double-blind, placebo-controlled trials, Studies 501 and 502, which both met their primary endpoints. On the Montgomery-Asberg Depression Rating Scale (MADRS), the separation from placebo at six weeks was -4.9 points (effect size 0.61) in Study 501 and -4.5 points (effect size 0.56) in Study 502. In the 26-week open-label extension Study 503, 80% of patients responded to treatment and 65% experienced remission, defined as a MADRS total score of 10 or less, at six months.
Johnson & Johnson said MDD affects about 22 million American adults and that two in three people continue to experience residual symptoms despite antidepressant treatment. The company listed common side effects including sleepiness, dizziness, nausea, dry mouth, fatigue, and diarrhea, and said weight and metabolic changes in the pivotal trials were similar to placebo. The efficacy and safety figures above are taken from the company's release.
Source: Johnson & Johnson
Published by GSM · USA (original Chinese edition)
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