FDA Approves Lumateperone for Bipolar Depression

The US Food and Drug Administration (FDA) has approved lumateperone (CAPLYTA) for adults with bipolar depression.

The treatment, developed by Intra-Cellular Therapies, represents the only FDA-approved therapy for depressive episodes associated with bipolar depression, both as a monotherapy and an adjunctive therapy with either lithium or valproate.

The approval is based on favorable safety, tolerability, and efficacy from a pair of positive phase 3 placebo-controlled bipolar depression studies.

The investigators found lumateperone 42 mg resulted in a statistically significant improvement over placebo in the change from baseline in the Montgomery-Asberg Depression Ratings scale (MADRS) total score at week 6, as well as a statistically significant improvement in key secondary endpoints relating to the clinical global impression of bipolar disorder in each study.

The treatment was also deemed safe and tolerable, with a safety profile consistent with previous findings for the treatment of schizophrenia. The most common adverse reactions included somnolence/sedation, dizziness, nausea, and dry mouth. The mean changes from baseline in weight, fasting glucose, total cholesterol, triglycerides, and LDL cholesterol were also similar between lumateperone and placebo.

“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),” Sharon Mates, Chairman and CEO of Intra-Cellular Therapies, said in a statement.

Depressive episodes for patients with either bipolar I or bipolar II tend to last longer, recur more often, and are linked to a worse prognosis than the manic/hypomanic episodes.