Topline results from a pivotal Phase 3 open-label extension study show the long-term safety and effectiveness of olanzapine and salmidofen (Lybalvi) in patients with schizophrenia, schizophreniform disorder, or bipolar I disorder . Following a previous olanzapine-samidofen study, this four-year investigation achieved promising results, with a significant proportion of participants completing the treatment period.
“We are pleased to share topline results from this long-term, open-label study. These data highlight the potential utility of Lybalvi as a primary maintenance treatment option for patients with schizophrenia or bipolar I disorder and strengthen the safety profile of Lybalvi developed by Alkermes Craig Hopkinson, MD, executive vice president and chief medical officer, said in a statement.
“In this study, patients taking Lybalvi experienced sustained treatment effects and tolerability, including stability of multiple metabolic parameters,” he continued. “Mean treatment duration with oral atypical antipsychotics was average. In the context of less than 6 months, we encouraged more than one-third of subjects to complete four years of Lybalvi treatment.”
The multicenter study enrolled 524 patients, 523 of whom received at least one dose of olanzapine-samidofen. The drug is approved in the U.S. for the treatment of schizophrenia and bipolar I disorder in adults and has demonstrated a consistent safety profile in global open-label extension studies. Safety assessment included changes in body weight and waist circumference, incidence of adverse events, and assessment of lipid and glycemic parameters. The study was designed to evaluate the long-term benefits of olanzapine-samidofen for up to 4 years, building on insights gained from a previous phase 3 clinical trial.
The study showed minimal changes in weight and waist circumference after up to 4 years of treatment, with mean changes from baseline of +1.47 kg and +0.61 cm respectively. Likewise, lipid and glycemic parameters, including high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, fasting blood glucose, and glycated hemoglobin, generally showed minimal changes over the time period measured.
Adverse events (AEs) were reported in 60% of patients, with the most common AEs (>5%) including weight gain, headache, anxiety, insomnia, somnolence, nausea, and weight loss. Most AEs were mild to moderate in severity.
said study author Jacob S. Ballon, Ph.D., MPH, clinical professor of psychiatry and behavioral sciences at Stanford University. “These data demonstrate long-term tolerability and symptom control, as well as stability of key body weight and metabolic factors, underscoring Lybalvi’s established safety and efficacy and providing insights for clinicians when making treatment decisions with patients in the real world. Important information provided.”
Alkermes plans to submit the results of this open-label, long-term study for publication in a peer-reviewed journal and intends to present additional findings at upcoming scientific meetings, the statement said. The company’s commitment to advancing understanding of the safety and effectiveness of olanzapine-samidofen reflects its commitment to providing valuable treatment options for individuals with complex mental health conditions.
Alkermes announces top results from the long-term, open-label safety and durability study of LYBALVI® (olanzapine and salmidofen) treatment efficacy. Press Releases. ALCMES LIMITED 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 -lybalvi-olanzapine and samidofen Treatment effect research-302024987.html