FDA approves bipolar depression treatment for broad range of adults
pharmafile | December 21, 2021 | News story | Manufacturing and Production |
Intra-Cellular Therapies, a biopharmaceutical company focused on the development and commercialisation of therapeutics for central nervous system (CNS) disorders, have announced the FDA approval of CAPLYTA for the treatment of depressive episodes associated with bipolar I or II disorder in adults. The treatment has been approved as monotherapy and as adjunctive therapy with lithium or valproate.
The FDA approval for CAPLYTA’s additional indications is based on two positive Phase III placebo-controlled bipolar depression studies. These studies evaluated the effects of CAPLYTA on depression in adult patients with bipolar I or bipolar II disorder, both as monotherapy (Study 404), and as adjunctive therapy with lithium or valproate (Study 402). CAPLYTA is the only FDA-approved treatment for depressive episodes associated with bipolar I or II disorder in adults as monotherapy and as adjunctive therapy with lithium or valproate.
Bipolar I and bipolar II disorder are highly prevalent psychiatric chronic conditions affecting approximately 11 million adults in the US. The conditions are characterised by recurrent episodes of mania or hypomania, interposed with episodes of major depression (bipolar depression). Bipolar depression is the most common and debilitating clinical presentation of bipolar disorder. These depressive episodes tend to last longer, recur more often, and are associated with a worse prognosis than the manic and hypomanic episodes. Bipolar depression represents a significantly underserved medical need.
Dr Roger McIntyre, Professor of Psychiatry and Pharmacology at the University of Toronto and Head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada, shared: “The efficacy, and favourable safety and tolerability profile, make CAPLYTA an important treatment option for the millions of patients living with bipolar I or II depression, and represents a major development for these patients. CAPLYTA is approved for a broad range of adult patients including those patients with bipolar II depression who have been underserved with limited treatment options.”
Ana Ovey
