Intra-Cellular Therapies, Inc. announced that the U.S. Food and Drug Administration (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. “We thank the patients, healthcare professionals and our Intra-Cellular team for all their contributions that led to this approval.”
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.
Bipolar depression is the most common and debilitating clinical presentation of bipolar disorder. These depressive episodes tend to last longer, recur more often, and are associated with a worse prognosis than the manic/hypomanic episodes. Bipolar depression is a significantly underserved medical need.
“The efficacy, and favorable safety and tolerability profile, make CAPLYTA an important treatment option for the millions of patients living with bipolar I or II depression and represents a major development for these patients. CAPLYTA is approved for a broad range of adult patients including those patients with bipolar II depression who have been underserved with limited treatment options,” said Dr. Roger McIntyre, Professor of Psychiatry and Pharmacology at the University of Toronto and Head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada.
The FDA approval for CAPLYTA’s additional indications is based on two positive Phase 3 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.
In addition, CAPLYTA demonstrated a favorable tolerability and safety profile consistent with findings in prior clinical studies in schizophrenia. The most common reported adverse reactions (occurring at a rate of 5% or more and at least twice the rate of placebo) were somnolence/sedation, dizziness, nausea, and dry mouth. Mean changes from baseline in weight, fasting glucose, total cholesterol, triglycerides, and LDL cholesterol were similar between CAPLYTA and placebo.
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