FDA approves Caplyta for depressive episodes in bipolar I, II disorders

The FDA has approved Caplyta for treating adults with depressive episodes linked to bipolar I or II disorder, according to a company press release.

The approval covers Caplyta (lumateperone, Intra-Cellular Therapies Inc.) as monotherapy and as adjunctive therapy with lithium or valproate.

“Caplyta has shown a consistent favorable profile on weight, cardiometabolic parameters and extrapyramidal symptoms (movement disturbances),” Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies, said in the release. “We are positioned to launch immediately and are excited to offer Caplyta to the millions of patients living with bipolar depression.”

The FDA based its approval on two positive phase 3 placebo-controlled studies of bipolar depression that examined the effects of lumateperone among adults with bipolar I or bipolar II disorder as monotherapy and as adjunctive therapy with lithium or valproate.

Lumateperone 42 mg correlated with statistically significant improvements vs. placebo in change from baseline on the Montgomery-Asberg Depression Rating scale (MADRS) total score at 6 weeks. It also demonstrated statistically significant improvement on the key secondary endpoint of clinical global impression of bipolar disorder in each study, as well as a favorable tolerability and safety profile consistent with results of prior clinical studies in schizophrenia.

The most commonly reported adverse events — somnolence/sedation, dizziness, nausea and dry mouth — occurred at a rate of at least 5% and at least twice the rate of placebo. Lumateperone and placebo demonstrated similar mean changes from baseline in weight, fasting glucose, total cholesterol, triglycerides and LDL cholesterol.

“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,” Roger McIntyre, MD, FRCPC, professor of psychiatry and pharmacology at the University of Toronto and head of the Mood Disorders Psychopharmacology Unit at the University Health Network in Canada, said in the release. “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.”