Title: Olanzapine/samidorphan in schizophrenia and bipolar I disorder: a profile of its use in the USA
Abstract: Olanzapine/samidorphan (LYBALVI®) is a useful treatment option for patients with schizophrenia or bipolar I disorder who could benefit from the antipsychotic efficacy of olanzapine, but for whom the potential for olanzapine-associated weight gain might otherwise preclude its use. In clinical trials (ENLIGHTEN-1 and ENLIGHTEN-2) in patients with schizophrenia, olanzapine/samidorphan had similar efficacy to olanzapine; samidorphan did not appear to impact the antipsychotic efficacy of olanzapine. In addition, olanzapine/samidorphan led to significantly less weight gain than olanzapine in ENLIGHTEN-2. Sustained benefits of olanzapine/samidorphan were evident with longer-term therapy. Weight gain and significant changes in metabolism are commonly caused by second-generation/atypical antipsychotics, including olanzapine. Olanzapine is one of the most effective antipsychotics, but is also associated with a high risk of weight gain especially at higher doses and with prolonged treatment. Weight gain can impact adherence, and thus treatment outcomes associated with antipsychotics. The combination of olanzapine with the new opioid antagonist samidorphan (olanzapine/samidorphan; LYBALVI®) is indicated for the treatment of adults with schizophrenia or bipolar I disorder, and offers the efficacy of olanzapine while mitigating olanzapine-associated weight gain. Compared with olanzapine, olanzapine/samidorphan had similar antipsychotic efficacy and led to significantly less weight gain. The benefits of olanzapine/samidorphan were durable with longer-term therapy. Olanzapine/samidorphan is a useful option for the treatment of schizophrenia and bipolar I disorder.