FDA approves new dosage strengths for bipolar, schizophrenia drug

The FDA has granted approval to Intra-Cellular Therapies Inc. for 10.5 mg and 21 mg dosages of lumateperone to treat schizophrenia and bipolar depression, according to a company release.

Lumateperone (Caplyta, Intra-Cellular) is indicated in adults as both monotherapy and adjunctive therapy with lithium or valproate and is available in 42 mg capsules, the company said in a press release.

“Caplyta 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),” Suresh Durgam, MD, executive vice president and chief medical officer of Intra-Cellular Therapies, said in the release. “Our label now provides dosage recommendations for specific patient needs. We believe Caplyta’s label reflects a strong clinical profile and provides prescribers with the necessary information to prescribe this important medicine.”

The new dosage strengths are expected to be available by mid-2022.