Intra-Cellular Therapies has recently submitted supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for two indications for CAPLYTA (lumateperone): 1) as monotherapy; and 2) as adjunctive therapy with lithium or valproate for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) 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. The Company anticipates an FDA target action date for the sNDAs in the second half of 2021.

Two positive Phase 3 global placebo-controlled bipolar depression studies, Study 402 and Study 404, form the basis of the sNDAs. In these trials, lumateperone 42 mg demonstrated a favorable tolerability and safety profile, consistent with findings in all of the Company’s 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.

“Bipolar I and II disorders are severe mental health conditions that affect approximately 11 million adults in the U.S. and there remains a significant need for more treatment options,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “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.”

Bipolar I and Bipolar II disorder are serious, highly prevalent psychiatric conditions affecting approximately 11 million adults in the U.S.

These disorders are characterized by recurrent episodes of mania or hypomania interspersed with episodes of major depression known as Bipolar depression. Bipolar I and Bipolar II each represent about half of the overall population of patients with bipolar disorder.

Bipolar depression is the most common clinical presentation of bipolar disorder. These episodes tend to last longer, recur more often, and are associated with a worse prognosis than the manic/hypomanic episodes. Bipolar depression remains a significantly underserved medical need, with only a few FDA-approved treatment options available. These treatments are commonly associated with tolerability issues.