FDA Approves Lumateperone for the Treatment of Bipolar Depression

Mean changes from baseline in weight, fasting glucose, total cholesterol, triglycerides, and low-density lipoprotein cholesterol were similar between lumateperone and placebo.

The FDA has approved lumateperone (Caplyta; Intra-Cellular Therapies) for the treatment of depressive episodes associated with bipolar I or II disorder in adults as monotherapy and as an adjunctive therapy with lithium or valproate.

Bipolar I and bipolar II disorders are psychiatric chronic conditions that impact approximately 11 million adults in the United States. According to a press release, they are characterized by recurrent episodes of mania or hypomania interposed with episodes of major depression. Bipolar depression is the most common and debilitating clinical presentation of bipolar disorder and depressive episodes tend to last longer, recur more often, and are associated with a worse prognosis than the manic or hypomanic episodes.

“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,” said Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies, in the press release. “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.”

The approval is based on 2 positive phase 3 placebo-controlled bipolar depression studies, which evaluated the effects of lumateperone on depression in adults with bipolar I or bipolar II disorder both as monotherapy and as adjunctive therapy with lithium or valproate. In the studies, the efficacy of 42 mg lumateperone 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. The 42 mg dosage also showed a statistically significant improvement in the key secondary endpoint relating to clinical global impression of bipolar disorder in each study.

Furthermore, lumateperone demonstrated a favorable tolerability and safety profile consistent with findings in earlier clinical studies of patients with schizophrenia. The most common reported adverse effect included somnolence or sedation, dizziness, nausea, and dry mouth. Mean changes from baseline in weight, fasting glucose, total cholesterol, triglycerides, and low-density lipoprotein cholesterol were similar between lumateperone and placebo.

“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,” said 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 Toronto, Canada, in the press 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.”

REFERENCE

Intra-Cellular Therapies Announces US FDA Approval of Caplyta (lumateperone) for the Treatment of Bipolar Depression in Adults. Intra-Cellular Therapies; December 20, 2021. Accessed December 20, 2021. https://ir.intracellulartherapies.com/news-releases/news-release-details/intra-cellular-therapies-announces-us-fda-approval-caplytar