Combining Samidorphan and Olanzapine Shows Mixed Results
NEW YORK CITY—The investigational olanzapine-samidorphan drug ALKS 3831 did not outperform olanzapine alone in reducing alcohol use in patients with schizophrenia and alcohol use disorder, but it did improve symptoms of schizophrenia, a study found.
The double-blind trial randomized 229 adults with schizophrenia and alcohol use disorder to olanzapine monotherapy or ALKS 3831, a combination of flexibly-dosed olanzapine and 10 mg of samidorphan. Close to 50% of patients in the olanzapine monotherapy arm and just over 47% of patients in the ALKS 3831 arm completed 9 months of treatment. Follow-up lasted up to 15 months after the study’s start.
“Although alcohol use improved over the course of follow-up in both arms, there was no benefit of ALKS 3831 over and above olanzapine plus placebo in the primary outcome of disease exacerbation,” reported poster presenter Mary F. Brunette, MD, and colleagues. Findings were presented at the American Psychiatric Association’s annual meeting.
Heavy drinking days were down 21.2% at 9 months and 16.9% at 15 months in the ALKS 3831 group, compared with 15% at 9 months and 13.2% at 15 months in the olanzapine group, according to the study.
Compared with participants taking olanzapine monotherapy, patients in the ALKS 3831 group had better improvement in total scores on both the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression-Severity (CGI-S) scale.
“Consistent with the primary outcome results, this post-hoc analysis showed no differences between ALKS 3831 and olanzapine monotherapy in alcohol behavior but revealed a general reduction of alcohol use in both arms,” researchers wrote. “In contrast, there were significant changes in PANSS and CGI that favored the ALKS 3831 group.”
Coauthors of the study, which was sponsored by ALKS 3831 developer Alkermes Inc., were Stephanie O'Malley, Leslie L. Citrome, MD, MPH, David McDonnell, Lauren DiPetrillo, Ying Jiang, Adam Simmons, Bernard Silverman, and Alan Ivan Green, MD.
“Schizophrenia complicated by comorbid alcohol use disorder: symptom outcomes from a phase 2 randomized controlled trial.” Abstract presented at: the American Psychiatric Association Annual Meeting; May 7, 2018; New York, NY.