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The FDA approved lumateperone (Caplyta) for bipolar-related depressive episodes, Intra-Cellular Therapies Monday.

The atypical antipsychotic gained an indication for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate. It was first approved for adults with schizophrenia in December 2019.

Although the novel drug's the mechanism of action is "unknown," the treatment's effect may be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors, according to drug developer Intra-Cellular Therapies.

The once-daily oral treatment can be taken with or without food. The label states that the recommended 42-mg dose does not require titration.

Lumateperone does carry a boxed warning label regarding increased mortality in elderly patients with dementia-related psychosis, as well as a possible increased risk for suicidal thoughts and behaviors in pediatric and young adult patients.

"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, of the University of Toronto, in a statement released by the manufacturer. "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."

"From a pharmacological standpoint, there were a few things that suggested [lumateperone] would work for depression, and that led us to go down this road," Andrew Satlin, MD, of Intra-Cellular Therapies in New York City, previously told 番茄社区app. "Some drugs for bipolar disorder are also atypical, but they don't have the same pharmacology as lumateperone does."

Lending support to this new indication were the positive findings from two phase III bipolar depression studies: one testing lumateperone as monotherapy and one testing it as adjunctive therapy with lithium or valproate. Both studies proved superiority over placebo on primary efficacy endpoints, demonstrating a significant change from in the Montgomery-Asberg Depression Rating scale total score at week 6. The drug also hit a key secondary endpoint in both studies, with significant improvement in clinical global impression of bipolar disorder.

Of note, lumateperone did not cause weight gain, a side effect common with antipsychotics. In fact, the weren't any significant changes from baseline in regards to key metabolic markers -- weight, fasting glucose, total cholesterol, triglycerides, or LDL cholesterol -- compared with placebo.

In the studies, the most common adverse events reported were somnolence and sedation, dizziness, nausea, and dry mouth.

Lumateperone is also being investigated for the treatment of major depressive disorder, as well as other neuropsychiatric and neurological disorders.

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