Intra-Cellular closing in on major depression nod for Caplyta
In Study 502, lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints Lumateperone 42 mg met the primary endpoint...
Lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints Lumateperone 42 mg met the primary endpoint of change...
NEW YORK, April 25, 2022 (GLOBE NEWSWIRE) -- 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) approved two new dosage strengths of CAPLYTA, 10.5 mg and 21 mg capsules, to provide dosage recommendations for patients concomitantly taking strong or moderate CYP3A4 inhibitors, and 21 mg for patients with moderate or severe hepatic impairment (Child-Pugh class B or C).
Two years ago, on Dec. 23, the U.S. regulator approved Intra-Cellular’s first product, Caplyta, for schizophrenia. Monday, the FDA expanded Caplyta’s label, endorsing it for bipolar depression.
NEW YORK, Dec. 20, 2021 (GLOBE NEWSWIRE) -- 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) approved CAPLYTA for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate.
In this study, lumateperone 42 mg showed significant reduction in depressive symptoms compared to placebo in patients with a major depressive episode associated with bipolar I or bipolar II disorder and a favorable safety and tolerability profile. These anti-depressant effects were statistically significant in both bipolar I and bipolar II disorder subgroup populations