FDA Grants New Indication to Lumateperone (Caplyta) for Bipolar Depression

Megan Brooks

December 20, 2021

The US Food and Drug Administration (FDA) has expanded approval of lumateperone (Caplyta) to include treatment of adults with depressive episodes associated with bipolar I and II disorder, as monotherapy or adjunctive therapy with lithium or valproate.

This makes lumateperone the only FDA-approved drug for this indication.

"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, professor of psychiatry and pharmacology, University of Toronto, Canada, and head of the Mood Disorders Psychopharmacology Unit, said in a company news release.   

As reported by Medscape Medical News, lumateperone was first approved by the FDA in 2019 for the treatment of adults with schizophrenia.

"Positioned to Launch Immediately"

The new indication stems from results of two phase 3 studies that showed treatment with lumateperone, alone or with lithium or valproate, significantly improved depressive symptoms for patients with major depressive episodes associated with bipolar I and bipolar II disorders.

In these studies, treatment with a 42 mg once-daily dose was associated with significantly greater improvement from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) score vs placebo, as reported previously by Medscape Medical News.

Lumateperone also showed a statistically significant improvement in the key secondary endpoint relating to clinical global impression of bipolar disorder.

Somnolence/sedation, dizziness, nausea, and dry mouth were the most commonly reported adverse events associated with the medication. Minimal changes were observed in weight and vital signs and in results of metabolic or endocrine assessments. Incidence of extrapyramidal symptom-related events was low and was similar to those with placebo. 

Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies, noted in the same press release that the company is "positioned to launch immediately and are excited to offer Caplyta to the millions of patients living with bipolar depression."

Full prescribing information is available online.

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