The US Food and Drug Administration (FDA) has approved Intra-Cellular Therapies, Inc’s CAPLYTA® (lumaterperone) for the treatment of adult bipolar depression.

Lumaterperone is a 42-mg oral, once-daily atypical antipsychotic previously approved for the treatment of schizophrenia in 2019.

Intensive Dietary Intervention Eases Mood Variability in Patients with Bipolar Disorder

According to Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies, “It is the only FDA-approved bipolar depression treatment for depressive episodes associated with bipolar I or II disorder in adults.” 

The approval stems from 2 Phase 3 placebo-controlled studies on bipolar depression evaluating the effects of CAPLYTA as a depression treatment for adult patients with bipolar I or bipolar II disorder. CAPLYTA was evaluated as both an adjunctive therapy with valproate or lithium, and as a monotherapy. It has been approved both as an adjunctive therapy and as a monotherapy.

“CAPLYTA demonstrated efficacy, and favorable safety and tolerability profile consistent with findings in prior clinical studies in schizophrenia. 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,” according to a press release. 

Approximately 11 million adults in the US are affected by bipolar I and bipolar II disorder, which is characterized by recurrent manic episodes or hypomania and episodes of major depression, also known as bipolar depression.  This is important news for patients with bipolar depression with limited treatment options.

“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 treatment is expected to be launched immediately.

Reference

Intra-Cellular Therapies announces U.S. FDA approval of CAPLYTA® (lumateperone) for the treatment of bipolar depression in adults. News release. Intra-Cellular Therapies, Inc. December 20, 2021. Accessed December 20, 2021.