Long-Term LYBALVI® Study Shows Stable Safety and Effectiveness

In a recent phase 3 study, LYBALVI® (a combination of olanzapine and samidorphan) demonstrated its safety and effectiveness in treating patients with schizophrenia, schizophreniform disorder, or bipolar I disorder over a period of up to four years. The open-label extension study involved 523 participants, of which 35.9% completed the entire four-year treatment period. The findings indicated that LYBALVI was generally well-tolerated, with stable body weight and metabolic profiles, and provided durable symptom control.

The Clinical Global Impression of Severity (CGI-S) scale was utilized to measure the stability of patients' symptoms, showing a mean change from baseline in CGI-S score of -0.28. Over the four-year treatment, there were minimal changes in body weight (mean change of +1.47 kg) and waist circumference (mean change of +0.61 cm). Additionally, lipid and glycemic parameters such as HDL cholesterol, LDL cholesterol, triglycerides, fasting glucose, and HbA1c remained largely unchanged.

Adverse events were reported by 60% of the patients, with the most common being weight gain, headache, anxiety, insomnia, somnolence, nausea, and weight decrease. The majority of these adverse events were classified as mild to moderate. The study's results support the established safety and efficacy profile of LYBALVI and highlight its potential as a foundational maintenance treatment option for the aforementioned mental health conditions.

The study's design included a multicenter, open-label extension approach, allowing patients to continue their daily dose of LYBALVI from previous studies for an additional four years, with dose adjustments made by investigators. The patient demographic was predominantly male (61.6%) and White (72.7%), with an average age of 35.1 years.

Schizophrenia and bipolar I disorder are serious brain disorders that affect mood, energy, and the ability to function. Schizophrenia is marked by a combination of positive and negative symptoms and affects about 1.1% of the U.S. population. Schizophreniform disorder presents similar symptoms but for a shorter duration. Bipolar I disorder is characterized by extreme mood swings, including manic episodes, and impacts approximately 1% of the adult U.S. population annually.

LYBALVI is a once-daily oral atypical antipsychotic medication approved for use in the U.S. for treating schizophrenia and bipolar I disorder. It is available in various fixed dosage strengths and combines olanzapine with samidorphan in a single bilayer tablet. The medication's safety information includes warnings about its use in elderly patients with dementia-related psychosis, contraindications for patients using opioids, and precautions regarding potential severe opioid withdrawal and the risk of life-threatening opioid overdose.

The study's results are expected to be submitted for publication in a peer-reviewed journal, and additional findings will be presented at future scientific gatherings. This research contributes valuable insights for clinicians making treatment decisions and underscores the importance of long-term tolerability and symptom control in managing complex mental health conditions.