Benzinga | May 3, 2021 07:33AM EDT

Intra-Cellular Therapies Announces FDA Acceptance of CAPLYTA sNDAs for the Treatment of Bipolar Depression

Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Applications (sNDAs) for lumateperone, an investigational agent for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 17, 2021 for the applications. If approved, CAPLYTA has the potential to be an important medicine for a broad group of patients suffering from these highly prevalent, chronic complex conditions.

Two positive Phase 3 global placebo-controlled bipolar depression studies, Study 402 and Study 404, form the basis of the CAPLYTA sNDAs for the treatment of bipolar depression. In these clinical trials, lumateperone 42 mg demonstrated a favorable tolerability and safety profile consistent with findings in all of our previous studies in schizophrenia. The most commonly reported adverse events (defined as a rate greater than or equal to 5% and at least twice the rate of placebo) were somnolence, dizziness and nausea. Importantly, the rates of akathisia, restlessness and extrapyramidal symptoms were low and similar to placebo.