Alkermes has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval of the investigational drug ALKS 3831, a combination of the antipsychotic olanzapine and samidorphan, a novel molecular entity.
SAN DIEGO—Children with bipolar disorder who were treated with lurasidone had a lower risk of all-cause and psychiatric-related hospitalization than those treated with aripiprazole or olanzapine, according to a retrospective claims database study.
SAN DIEGO—Side effects were experienced nearly universally by respondents in an online survey who took oral antipsychotics the previous year for bipolar I disorder, according to results presented at a Psych Congress 2019 poster session.
Alkermes plc is expanding its New Drug Application (NDA) for the investigational drug ALKS 3831—a combination of the antipsychotic olanzapine and the novel molecular entity samidorphan—to include the treatment of bipolar I disorder as well as schizophrenia, the drugmaker recently announced.
Lumateperone, an investigational drug from Intra-Cellular Therapies, Inc., posted varied results in two phase 3 clinical trials evaluating it as a monotherapy for major depressive episodes associated with bipolar disorder.
SAN FRANCISCO—The antipsychotic cariprazine was effective in improving depressive symptoms in patients with bipolar depression and concurrent manic symptoms, according to a poster presented at the American Psychiatric Association’s annual meeting.