FDA Approves 2 Dose Strengths of Caplyta for Treatment of Schizophrenia

The FDA has approved 2 new dose strengths for lumateperone (Caplyta; Intra-Cellular Therapies, Inc) at 10.5 and 21 mg in capsule form.

The company will provide dosage recommendations for individuals concomitantly taking moderate to strong CYP3A4 inhibitors and the 21-mg strength for individuals with moderate or severe hepatic impairment.

“Lumateperone 42 mg has demonstrated efficacy in the treatment of bipolar depression and schizophrenia with a favorable profile on weight, metabolic parameters, and extrapyramidal symptoms [movement disturbances]. Lumateperone is a once-a-day medication that does not require dose titration and can be taken with or without food,” Suresh Durgam, MD, executive vice president and chief medical officer of Intra-Cellular Therapies, said in a statement.

“Our label now provides dosage recommendations for specific patient needs. We believe lumateperone’s label reflects a strong clinical profile and provides prescribers with the necessary information to prescribe this important medicine,” Durgam said.

The new dosage strengths are expected to be available in pharmacies in mid-2022. Lumateperone is available in the 42-mg capsule dosage.

Lumateperone is a once-a-day, oral atypical antipsychotic indicated for the treatment of depressive episodes associated with bipolar I or II disorder or schizophrenia as either a monotherapy and as an adjunctive therapy with lithium or valproate.

Additionally, the drug is also being studied for the treatment of major depressive disorder as well as other neurological and neuropsychiatric disorders, though the FDA has not approved it for these indications.

The efficacy of the drug could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

The most common adverse reactions were dizziness, dry mouth, nausea, and somnolence/sedation.

Lumateperone is contradicted for individuals with known hypersensitivity to the drug or any components of it. Reactions have included pruritus, rash, and urticaria.

Additionally, elderly individuals with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death. Antipsychotic drugs have also been reported to cause cerebrovascular adverse reactions. Lumateperone is not indicated for this patient population.

Antidepressants also increase the risk of suicidal behavior and thoughts for adolescents and children. The effectiveness and safety of the drug has not been established in this patient population.

Antipsychotic drugs can also cause agranulocytosis, body temperature dysregulation, cognitive and motor impairment, decreased blood pressure and dizziness, dysphagia, leukopenia, metabolic changes, neuroleptic malignant syndrome, neutropenia, seizures, and tardive dyskinesia .

The drug should not be used with CYPA4 inducers, and a dose reduction is recommended for concomitant use with moderate or strong CYP3A4 inhibitors.

Newborns who are exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Breastfeeding while on the drug is not recommended. Dose reduction is also recommended for individuals with moderate or severe hepatic impairment.

Reference

Intra-Cellular Therapies announces FDA approval of new dosage strengths for Caplyta (lumateperone) for specific patient populations. Globe News Wire. News release. April 25, 2022. Accessed April 25, 2022. Email.