Alkermes presents results from long-term safety study of LYBALVI

Alkermes announced the oral presentation of clinical data at the 2024 Congress of the Schizophrenia International Research Society, which took place April 3-7, 2024 in Florence, Italy. Analyses were presented from a phase 3, open-label extension study assessing the long-term safety, tolerability and durability of treatment effect of LYBALVI in patients who received up to four years of treatment. LYBALVI is approved in the U.S. for the treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or as adjunct to lithium or valproate. Rene Kahn, M.D., Ph.D., Icahn School of Medicine at Mount Sinai, presented the data in an oral presentation during the “New Pharmacological Treatments and Assessments” session. New analyses were presented related to the subset of participants in the study who reached at least two years of treatment and the subset of participants who reached four years of treatment, providing information as to the long-term safety profile and durability of treatment effect of LYBALVI at specific points in time. Key findings are as follows: Patient Disposition: 523 participants received at least one dose of LYBALVI in this global, open-label extension study. Depending on geography and enrollment date, patients had the opportunity to receive up to two to four years of treatment in this study. 188 (35.9%) participants completed the study, as defined in the protocol, having received between two to four years of treatment and attended their final study visit. There were 451 patients who had the opportunity to receive at least two years of LYBALVI treatment, of which 242 (53.7%) did so. There were 335 patients who had the opportunity to receive four years of LYBALVI treatment, of which 109 (32.5%) did so. Changes in Weight, Waist Circumference, and Metabolic Parameters: For patients who contributed data to the two-year assessment, mean change from baseline in body weight was 0.84 kg and waist circumference was -0.56 cm. For patients who contributed data to the four-year assessment, the mean change from baseline in body weight was 2.65 kg and waist circumference was 1.37 cm. In addition, there were minimal changes in lipid and glycemic parameters over the treatment period. Adverse Events: The adverse event profile of LYBALVI was consistent with previous studies. Overall, 60% of participants reported at least one AE. The most common AEs reported were weight increase, headache, anxiety, insomnia, somnolence, nausea and weight decrease. Most AEs were mild to moderate in severity. Symptoms: Patients’ symptoms of schizophrenia or bipolar I disorder remained stable, as measured by the Clinical Global Impression of Severity scale. For patients who contributed data to the two-year assessment, mean change from baseline in CGI-S score was -0.18. For patients who contributed data to the four-year assessment, mean change from baseline in CGI-S was -0.24. According to Dr. Kahn, “The study results, which include data from patients who received up to four years of treatment on LYBALVI, demonstrated that the combination of olanzapine and samidorphan delivered long-term tolerability, including across key weight and metabolic parameters, and sustained symptom control, further reinforcing LYBALVI’s potential utility as a foundational maintenance treatment option for people living with schizophrenia or bipolar I disorder.”