Alkermes Presents Analyses From Long-Term Safety Study of LYBALVI® (olanzapine and samidorphan) at 2024 Congress of the Schizophrenia International Research Society

Core Insights - Alkermes plc presented clinical data on LYBALVI® at the 2024 Congress of the Schizophrenia International Research Society, highlighting its long-term safety, tolerability, and treatment durability in patients with schizophrenia and bipolar I disorder [1][2][3] Patient Disposition - A total of 523 participants received at least one dose of LYBALVI in the study, with 188 (35.9%) completing the study after two to four years of treatment [2] - Of the 451 patients eligible for at least two years of treatment, 242 (53.7%) participated, while 335 patients had the opportunity for four years of treatment, with 109 (32.5%) completing it [2] Weight and Metabolic Changes - For the two-year assessment, the mean change in body weight was an increase of 0.84 kg, while waist circumference decreased by 0.56 cm [2] - In the four-year assessment, the mean change in body weight was an increase of 2.65 kg, and waist circumference increased by 1.37 cm, with minimal changes in lipid and glycemic parameters [2] Adverse Events - The adverse event profile was consistent with previous studies, with 60% of participants reporting at least one adverse event [2] - Common adverse events included weight increase, headache, anxiety, insomnia, somnolence, nausea, and weight decrease, most of which were mild to moderate in severity [2] Symptom Control - Patients' symptoms of schizophrenia or bipolar I disorder remained stable, as measured by the Clinical Global Impression of Severity (CGI-S) scale, with mean changes from baseline of -0.18 for two years and -0.24 for four years [2][3] Study Design - The study was an international, multicenter, phase 3, open-label extension assessing LYBALVI's long-term safety and efficacy for up to four years [4] - Patients were enrolled within seven days of completing prior phase 3 clinical trials, with a daily dose of LYBALVI ranging from 5-20 mg of olanzapine and 10 mg of samidorphan [4][5] Company Overview - Alkermes plc is a global biopharmaceutical company focused on developing innovative medicines for neurological disorders, with a portfolio that includes treatments for schizophrenia and bipolar I disorder [22]