New York-based Intra-Cellular Therapies published the results of the company’s Study 404 phase III trial of lumateperone as monotherapy for major depressive episodes associated with bipolar I or bipolar II disorder.
Alkermes Plc said on June 1 the U.S. Food and Drug Administration approved the company’s Lybalvi for the treatment of schizophrenia and bipolar I disorder.
The U.S. Food and Drug Administration issued a Complete Response Letter for Alkermes’ New Drug Application for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and bipolar 1 disorder, and a CRL for Adamis Pharmaceuticals’ NDA for the high-dose naloxone injection product ZIMHI for the treatment of opioid overdose.
Allergan Plc’s Vraylar won U.S. regulatory approval to treat depressive episodes of bipolar I disorder, expanding the scope of treatment to a full spectrum of symptoms related to the condition.
Denmark’s H. Lundbeck and Japan’s Otsuka Pharmaceutical announced that the antipsychotic drug Rexulti (brexpiprazole) failed to meet the primary endpoint in two Phase III clinical studies to treat manic episodes in patients with bipolar I disorder.