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Findings From Long-Term Analysis of the Effects of LYBALVI® (olanzapine and samidorphan) on Negative Symptoms of Schizophrenia Published in The Journal of Clinical Psychiatry

ALKS
  • Alkermes plc published a 56-week post hoc analysis in The Journal of Clinical Psychiatry demonstrating sustained reduction in hard-to-treat negative symptoms in adults with schizophrenia treated with LYBALVI.
  • The analysis utilized data from 281 adults who completed the 4-week ENLIGHTEN-1 study & enrolled in the subsequent 52-week open-label ENLIGHTEN-1 Extension study.
  • Treatment with LYBALVI was associated with mean improvements in PANSS Negative Symptoms Subscale scores & Marder Negative Factor scores from baseline through week 56.
  • Patients with prominent negative symptoms showed a decrease in PANSS Negative Symptoms Subscale scores of -8.7 & Marder Negative Factor scores of -9.6 by week 56.
  • Patients with predominant negative symptoms/low positive symptoms showed a decrease in Marder Negative Factor scores of -8.9 by week 56.
  • LYBALVI is approved in the U.S. for treating schizophrenia in adults & bipolar I disorder in adults as monotherapy or adjunct therapy with lithium or valproate.
  • The study assessed efficacy using the 30-item Positive and Negative Syndrome Scale (PANSS) across Negative Symptoms, Positive Symptoms, & General Psychopathology subscales.
  • Christoph U. Correll, M.D., noted that the analysis further validates LYBALVI's utility for treating the complex symptomology of schizophrenia, including negative symptoms.
  • Important safety information includes a Boxed Warning regarding increased mortality risk in elderly patients with dementia-related psychosis.
  • LYBALVI is contraindicated in patients using opioids or undergoing acute opioid withdrawal due to the risk of precipitating severe opioid withdrawal.
  • Common adverse reactions observed in schizophrenia clinical trials included increased weight, somnolence, dry mouth, & headache.
  • Metabolic changes such as hyperglycemia, diabetes mellitus, dyslipidemia, & weight gain are potential risks requiring periodic monitoring.
  • The analysis is limited by the absence of a control group in the 52-week extension phase & the relatively small number of patients with predominant negative symptoms.