Alkermes Presents Long Term Data Supporting LYBALVI in Schizophrenia and Bipolar I Disorder

Alkermes plc (Nasdaq: ALKS) has presented clinical data from its Phase 3 open-label extension study of LYBALVI® (olanzapine and samidorphan) at the 2024 Congress of the Schizophrenia International Research Society (SIRS) in Florence, Italy this month.

Alkermes’ study assessed the long-term safety, tolerability and durability of treatment effect of LYBALVI for up to four years in adults with schizophrenia or bipolar I disorder. Patients’ symptoms of schizophrenia or bipolar I disorder remained stable.

René Kahn, M.D., Ph.D., of the Icahn School of Medicine at Mount Sinai, said, “The study results, which include data from patients who received up to four years of treatment on LYBALVI, demonstrated that the combination of olanzapine and samidorphan delivered long-term tolerability, including across key weight and metabolic parameters, and sustained symptom control, further reinforcing LYBALVI’s potential utility as a foundational maintenance treatment option for people living with schizophrenia or bipolar I disorder.” 


LYBALVI® (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug approved in the U.S. for the treatment of adults with schizophrenia or bipolar I disorder.

Schizophrenia is a serious brain disorder marked by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and agitated or repeated movements) and negative symptoms (depression, blunted emotions and social withdrawal).

Bipolar disorder is a brain disorder that is marked by extreme changes in a person’s mood, energy and ability to function. Individuals with this brain disorder may experience debilitating mood states, including extreme highs (mania) and extreme lows (depression).

About Alkermes plc

Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at


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Alkermes Presents Long Term Data Supporting LYBALVI in Schizophrenia and Bipolar I Disorder

Catie Corcoran

Biotech Editor