FDA approval of Caplyta for the treatment of bipolar depression in adults. Intra-Cellular Therapies.
Intra-Cellular Therapies, Inc. has announced that the FDA approved Caplyta for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate.
“Caplyta is the only medication approved by the FDA to treat depressive disorders associated with bipolar I or bipolar II as both monotherapy and adjunctive therapy with lithium or valproate. Caplyta has shown a consistent favorable profile on weight, cardiometabolic parameters and extrapyramidal symptoms (movement disturbances). We are positioned to launch immediately and are excited to offer Caplyta to the millions of patients living with bipolar depression,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.
Bipolar I and bipolar II disorder are serious, highly prevalent psychiatric chronic conditions affecting approximately 11 million adults in the U.S., characterized by recurrent episodes of mania or hypomania interposed with episodes of major depression (bipolar depression). Bipolar I and bipolar II disorder each represent about half of the overall population of patients with bipolar disorder.
The FDA approval for Caplyta’s additional indications is based on two positive Phase III placebo-controlled bipolar depression studies, which evaluated the effects of Caplyta on depression in adult patients with bipolar I or bipolar II disorder both as monotherapy (Study 404) and as adjunctive therapy with lithium or valproate (Study 402). In these studies, the efficacy of Caplyta 42 mg was established by demonstrating statistically significant improvements over placebo for the change from baseline in the Montgomery-Asberg Depression Rating scale (MADRS) total score at week 6. Caplyta 42 mg also showed a statistically significant improvement in the key secondary endpoint relating to clinical global impression of bipolar disorder in each study.
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Intra-Cellular Therapies, Inc. announced positive topline results from its Phase III clinical trial (Study 402) evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder In Study 402, once daily lumateperone 42 mg met the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the MADRS total score (p=0.0206; effect size = 0.27).