Alkermes plc today presented new research from its psychiatry portfolio at the 2022 Congress of the Schizophrenia International Research Society (SIRS).
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.
