Phase 3 Topline Results Support Sustained Efficacy, Tolerability of Treatment for Schizophrenia, Bipolar I Disorder


The data assess the extended efficacy of the treatment for up to 4 years.



Alkermes plc released topline results from a phase 3, open-label extension study assessing the extended safety, tolerability, and treatment effect durability of Lybalvi (olanzapine and samidorphan) in patients with schizophrenia, schizophreniform disorder, or bipolar I disorder over up to 4 years of treatment.

“We are pleased to share the topline results from this long-term, open-label study,” said Craig Hopkinson, MD, executive vice president of research and development and chief medical officer at Alkermes, in a press release. “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.”

The global open-label extension study included 523 participants, with 35.9% completing the 4-year treatment period. The safety profile of Lybalvi remained consistent with previous studies, and patients exhibited stable symptoms of schizophrenia or bipolar I disorder, as measured by the Clinical Global Impression of Severity (CGI-S) scale (mean change from baseline in CGI-S score of -0.28). Over the 4-year treatment, minimal changes were observed in body weight (mean change from baseline of +1.47 kg) and waist circumference (+0.61 cm). Additionally, there were generally minimal alterations in lipid and glycemic parameters, including HDL cholesterol, LDL cholesterol, triglycerides, fasting glucose, and HbA1c.1

Approximately 60% of patients reported at least 1 adverse event, with the most common adverse events (>5%) being weight gain, headache, anxiety, insomnia, somnolence, nausea, and weight decrease. Most adverse events were mild to moderate in severity.1

“In this study, patients taking Lybalvi experienced sustained treatment effect and tolerability, including stability across multiple metabolic parameters,” Hopkinson said in a press release. “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 4 years of treatment with Lybalvi.”

Lybalvi is a once-daily, oral atypical antipsychotic that is currently approved by the US Food & Drug Administration (FDA) in the United States for the treatment of adults with schizophrenia and adults with bipolar I disorder, either as maintenance monotherapy or for acute treatment of manic or mixed episodes, as monotherapy, or as an adjunct to lithium or valproate. Alkermes plans to submit these results exploring the extended safety, tolerability, and treatment effect durability of the drug for publication in a peer-reviewed journal and to present additional findings at upcoming scientific meetings.1

“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,” said Jacob S. Ballon, MD, MPH, clinical professor of psychiatry and behavioral sciences at Stanford University and one of the study’s investigators, in a press release.

“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.”

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Note: This article was prepared with the assistance of ChatGPT.


1. Alkermes announces topline results from long-term, open-label safety and durability of treatment effect study of Lybalvi (olanzapine and samidorphan). Alkermes. News release. January 3, 2024. Accessed January 4, 2024.*bwzs57*_gcl_au*MzM3NzM5ODk1LjE3MDQ0MDQyMDY.*_ga*MTg1MDQ5Njg1LjE3MDQ0MDQyMDY.*_ga_PFXKBM41R2*MTcwNDQwNDIwNi4xLjAuMTcwNDQwNDIwNi42MC4wLjA.

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