FDA Approves First Monotherapy For Bipolar Depression

On December 17, 2021, the U.S. Food and Drug Administration (FDA) approved the antipsychotic Caplyta (lumateperone) as the first monotherapy for depressive episodes associated with bipolar I or II disorder in adults. Caplyta can be used as monotherapy and as adjunctive therapy with lithium or valproate. It is the only FDA-approved medication approved for use in this way for bipolar depression.

Caplyta was developed by Intra-Cellular Therapies, Inc., a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders. Sharon Mates, Ph.D., chairman and chief executive officer of Intra-Cellular . . .