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If approved by the FDA, this treatment would be the first therapy for treating depressive episodes in both bipolar I and II disorder in 2 different forms.
Intra-Cellular Therapies announced that it has recently submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) for 2 indications for CAPLYTA (lumateperone), the first as monotherapy, the second as adjunctive therapy with lithium or valproate for the treatment of depressive episodes associated with bipolar I or II disorder in adults. If approved, CAPLYTA would be the first therapy indicated for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults.
“Bipolar I and II disorders are severe mental health conditions that affect approximately 11 million adults in the US and there remains a significant need for more treatment options,” Sharon Mates, PhD, Chairman and CEO of Intra-Cellular Therapies, said to the press. “We believe CAPLYTA has the potential to be an important option for patients in the treatment of bipolar depression. We look forward to bringing CAPLYTA to market, if approved, for the treatment of bipolar depression.”1
Intra-Cellular Therapies conducted 2 positive phase 3 studies, Study 402 and Study 404, which form the basis of the sNDAs. In these studies, lumateperone 42 mg demonstrated a favorable safety and tolerability profile, with the most common adverse events being somnolence, dizziness, and nausea. The findings were consistent with previous studies in schizophrenia. Rates of akathisia, restlessness, and extrapyramidal symptoms were similar to placebo.
Results from Study 404 have been presented at scientific conferences already, and results from Study 402 will be presented at the American Psychiatric Association 2021 annual meeting in May.
The company anticipates an FDA target action date for the sNDAs in the second half of 2021.
1. BioSpace. Intra-Cellular Therapies applies for FDA approval of CAPLYTA® (lumateperone) for the treatment of bipolar depression. News release. February 22, 2021. https://www.biospace.com/article/releases/intra-cellular-therapies-applies-for-fda-approval-of-caplyta-lumateperone-for-the-treatment-of-bipolar-depression/