ALKS 3831 appears safe, effective for adults with acutely exacerbated schizophrenia
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A combination of olanzapine and samidorphan demonstrated clinically significant efficacy improvements compared with placebo among adults with acutely exacerbated schizophrenia, according to results of the randomized, phase 3 ENLIGHTEN-1 study published in Journal of Clinical Psychiatry. The treatment, ALKS 3831 (Alkermes), also appeared well-tolerated.
“Olanzapine is one of the most effective antipsychotics, but its use is often limited by its association with weight gain," Jelena Kunovac, MD, founder and president of Altea Research, told Healio Psychiatry. "Results from this study demonstrate that ALKS 3831 appears to retain the efficacy of olanzapine with the added benefit of mitigating weight gain.”
Kunovac and colleagues sought to determine the antipsychotic efficacy and safety of ALKS 3831, which combines olanzapine with the opioid receptor antagonist samidorphan to mitigate weight gain, in a 4-week, double-blind and placebo- and olanzapine-controlled study among adults with schizophrenia according to the DSM-5 who were experiencing an acute exacerbation. They randomly assigned patients 1:1:1 to ALKS 3831, olanzapine monotherapy or placebo. Change in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions-Severity of Illness Scale (CGI-S) score between baseline and 4 weeks, respectively, for ALKS 3831 vs. placebo was the primary and key secondary efficacy endpoint.
The researchers administered at least one dose of study drug to 401 patients, of whom 352 completed treatment. Results showed ALKS 3831 conferred significant improvements vs. placebo in CGI-S (P = .002) and PANSS (P < .001) scores from baseline to 4 weeks. Similar improvements occurred with olanzapine treatment. The researchers reported adverse events in 54.5%, 54.9% and 44.8% of patients on ALKS 3831, olanzapine and placebo, respectively. The most common adverse events with active treatment were weight gain, somnolence, dry mouth, anxiety and headache.
"The ALKS 3831 development program is an example of Alkermes’ commitment to developing new treatment options that may help people living with serious mental illness,” Craig Hopkinson, MD, executive vice president of research and development and chief medical officer at Alkermes, said in a press release. "We look forward to continuing to work with the FDA as it reviews the NDA for ALKS 3831, with the goal of helping to bring this potential new medicine to patients and their families." – by Joe Gramigna
Disclosures: Hopkinson is an employee of Alkermes. Kunovac reports being the founder of Altea Research Institute and a co-founder of Excell Research, as well as a consultant and/or advisory board member for AstraZeneca, Bristol-Myers Squibb, Janssen, Novartis, Otsuka, Pfizer and Sunovion. Please see the study for all other authors’ relevant financial disclosures.