Alkermes announced that the peer-reviewed publication, Journal of Clinical Psychiatry, has published data from the phase 3 ENLIGHTEN-1 clinical trial of ALKS 3831 (olanzapine/samidorphan) in patients experiencing an acute exacerbation of schizophrenia. A New Drug Application (NDA) for ALKS 3831 is currently under U.S. Food and Drug Administration (FDA) review, with a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020.
Positive topline data from the ENLIGHTEN-1 study were first reported in June of 2017. The multinational, double-blind, randomized, phase 3 study evaluated the antipsychotic efficacy, safety, and tolerability of ALKS 3831 compared to placebo over four weeks in 403 patients experiencing an acute exacerbation of schizophrenia. The study also included a comparator arm of olanzapine, an established atypical antipsychotic agent with proven efficacy. The study met the prespecified primary endpoint, with ALKS 3831 demonstrating statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) scores compared to placebo. Data from the study also showed that olanzapine achieved similar improvements from baseline PANSS scores compared to placebo. The study also met its key secondary endpoint of improvement on the Clinical Global Impression – Severity (CGI-S) scale for ALKS 3831 versus placebo. The most common adverse events for both the ALKS 3831 and olanzapine treatment groups were weight gain, somnolence, and dry mouth.
About ALKS 3831
ALKS 3831 is a novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. ALKS 3831 is composed of samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.
Schizophrenia is a serious brain disorder marked by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and agitated or repeated movements) and negative symptoms (depression, blunted emotions and social withdrawal). An estimated 2.4 million American adults have schizophrenia, with men and women affected equally.Source: Alkermes