Extended Study Shows Consistent Safety, Efficacy in Complex Mental Health Treatment

Topline results from a pivotal phase 3, open-label extension study showcased the long-term safety and efficacy of olanzapine and samidorphan (Lybalvi) in patients with schizophrenia, schizophreniform disorder, or bipolar I disorder. The 4-year investigation, following prior olanzapine-samidorphan studies, yielded promising findings, with a substantial percentage of participants completing the treatment period.

"We are pleased to share the topline results from this long-term, open-label study. These data highlight the potential utility of Lybalvi as a foundational maintenance treatment option for people living with schizophrenia or bipolar I disorder and reinforce the safety profile of Lybalvi established in previous studies," Craig Hopkinson, MD, executive vice president, research and development and chief medical officer, Alkermes, said in the statement.

"In this study, patients taking Lybalvi experienced sustained treatment effect and tolerability, including stability across multiple metabolic parameters,” he continued. “Against the backdrop of average treatment persistency of less than 6 months for oral atypical antipsychotics generally, we are encouraged that more than one-third of subjects completed four years of treatment with Lybalvi."

The multicenter study enrolled 524 patients, with 523 receiving at least one dose of olanzapine-samidorphan. The drug, already approved in the US for the treatment of adults with schizophrenia and bipolar I disorder, demonstrated a consistent safety profile in the global, open-label extension study. Safety assessments included changes in body weight and waist circumference, incidence of adverse events, and evaluations of lipid and glycemic parameters. The study's design aimed to assess the long-term benefits of olanzapine-samidorphan for up to 4 years, building on the insights gained from antecedent phase 3 clinical trials.

The study revealed minimal changes in body weight and waist circumference, with a mean change from baseline of +1.47 kg and +0.61 cm, respectively, after up to 4 years of treatment. Similarly, lipid and glycemic parameters, including HDL cholesterol, LDL cholesterol, triglycerides, fasting glucose, and HbA1c, showed generally minimal changes over the measured time period.

Adverse events (AEs) were reported by 60% of patients with the most common AEs (> 5%) being weight gain, headache, anxiety, insomnia, somnolence, nausea, and weight decrease. Most AEs were mild to moderate in severity.

"As clinicians, we see firsthand the challenges that people living with complex mental health conditions may face in finding treatment options that work for them long term, in terms of both efficacy and tolerability," study author Jacob S. Ballon, MD, MPH, clinical professor of psychiatry and behavioral sciences at Stanford University stated. "These data, which demonstrated long-term tolerability and symptom control, as well as stability across key weight and metabolic factors, underscore Lybalvi’s established safety and efficacy profile and provide important information for clinicians as we navigate treatment decisions with our patients in the real world."

Alkermes plans to submit the results from this open-label, long-term study to a peer-reviewed journal for publication and intends to present additional findings at upcoming scientific meetings, according to the statement. The company's commitment to advancing the understanding of olanzapine-samidorphan’s safety and efficacy profile reflects its dedication to providing valuable treatment options for individuals with complex mental health conditions.

Reference

Alkermes announces topline results from long-term, open-label safety and durability of treatment effect study of LYBALVI® (olanzapine and samidorphan). News release. Alkermes plc. January 3, 2024. Accessed January 23, 2024. https://www.prnewswire.com/news-releases/alkermes-announces-topline-results-from-long-term-open-label-safety-and-durability-of-treatment-effect-study-of-lybalvi-olanzapine-and-samidorphan-302024987.html