DUBLIN — Alkermes plc announced the publication of a 56-week post hoc analysis showing that LYBALVI (olanzapine and samidorphan) was associated with sustained reductions in negative symptoms in adults with schizophrenia.
The findings, published in The Journal of Clinical Psychiatry, add to existing research on LYBALVI, which is approved in the U.S. for the treatment of schizophrenia in adults and for bipolar I disorder in adults, including as a maintenance monotherapy and for the acute treatment of manic or mixed episodes, either alone or with lithium or valproate.
Negative symptoms of schizophrenia, which can include reduced emotional expression, limited speech, lack of motivation, social withdrawal and diminished ability to experience pleasure, are often linked to reduced functioning and poor treatment response.
“Publication of this negative symptom post hoc analysis adds to a growing body of evidence supporting the role of LYBALVI in treating the complex symptomology related to schizophrenia,” said Craig Hopkinson, M.D. (MBChB), Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. “Alkermes remains committed to expanding the field’s understanding of this challenging disease and the impact of medicine in helping patients manage their illness. We look forward to continued engagement with the scientific community in this important discourse.”
The analysis used data from 281 adults who completed ENLIGHTEN-1, a four-week inpatient study evaluating the efficacy, safety and tolerability of LYBALVI compared with olanzapine and placebo in patients experiencing an acute exacerbation of schizophrenia. Those patients then enrolled in a 52-week open-label extension study in which all participants received LYBALVI.
Researchers assessed symptoms using the 30-item Positive and Negative Syndrome Scale, examining negative symptoms, positive symptoms and general psychopathology, along with Marder Negative Factor scores. The analysis also reviewed subgroups of patients with prominent negative symptoms and those with predominant negative symptoms and low positive symptoms at baseline.
The results showed that negative symptoms declined during the first four weeks in a pooled analysis of treatment arms from ENLIGHTEN-1 and continued to improve during the 52 weeks of open-label treatment with LYBALVI.
Among all patients, least squares mean changes from baseline in PANSS Negative Symptoms Subscale scores were minus 4.1 at week 4 and minus 7.6 at week 56. Mean changes in Marder Negative Factor scores were minus 4.5 at week 4 and minus 8.2 at week 56.
Among patients with prominent negative symptoms at baseline, least squares mean changes in PANSS Negative Symptoms Subscale scores were minus 4.6 at week 4 and minus 8.7 at week 56. Mean changes in Marder Negative Factor scores in that subgroup were minus 5.0 at week 4 and minus 9.6 at week 56.
Patients with predominant negative symptoms at baseline showed a similar pattern, with Marder Negative Factor scores falling by 4.7 points at week 4 and 8.9 points at week 56.
“LYBALVI has already been shown to provide the established efficacy of olanzapine as measured by PANSS total scores while mitigating olanzapine-associated weight gain and its effects on positive symptoms of schizophrenia have been evaluated,” said study author Christoph U. Correll, M.D., Professor of Psychiatry at The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. “This post hoc analysis of the effect of LYBALVI on negative symptoms, which remain a persistent treatment challenge, further validates LYBALVI’s utility for the treatment of schizophrenia, a condition characterized by complex symptom domains.”
