Poster
74
(#74) Olanzapine and Samidorphan in Adults With Schizophrenia or Bipolar I Disorder: Updated Review of Clinical Data
Psych Congress 2025
Abstract: INTRODUCTION: Combined olanzapine and samidorphan (OLZ/SAM) received US FDA approval in 2021 for the treatment of adults with schizophrenia or bipolar I disorder (BD-I) and was accompanied by a clinical data review summarizing OLZ/SAM's efficacy and safety. The key highlight was that OLZ/SAM provides the established antipsychotic efficacy of olanzapine while mitigating olanzapine-associated weight gain.
METHODS: This updated review synthesizes the following clinical studies/analyses conducted over the past 5 years, providing a comprehensive overview of the OLZ/SAM clinical program. Effectiveness, safety, and tolerability of OLZ/SAM were assessed in a 12-week randomized double-blind study conducted in early-in-illness patients, a population at risk of antipsychotic-associated weight gain. A 4-year open-label extension study and subgroup analysis evaluated long-term safety and durability of treatment effect of OLZ/SAM in patients who completed prior studies. An individual patient data meta-analysis compared effects of OLZ/SAM versus olanzapine on weight gain using data from 3 clinical trials. A post hoc analysis explored effects of OLZ/SAM treatment on negative symptoms in patients with an acute exacerbation of schizophrenia. Patient retention rates were also summarized across the OLZ/SAM phase 3 clinical program.
RESULTS: OLZ/SAM treatment was associated with a durable antipsychotic treatment effect, clinically meaningful and durable improvement from baseline in the negative symptoms of schizophrenia, and minimal weight gain and metabolic changes for up to 5 years. Treatment with OLZ/SAM was well tolerated, and substantial retention rates were observed.
CONCLUSIONS: These data reinforce OLZ/SAM as a valuable long-term treatment option for patients with schizophrenia or BD-I.
Short Description: Combined olanzapine/samidorphan (OLZ/SAM) was approved by the US FDA in 2021 for the treatment of schizophrenia and bipolar I disorder (BD-I) and was accompanied by a clinical data review summarizing its efficacy/safety. This updated review synthesizes clinical studies/analyses from the past 5 years, with findings of durable treatment effect, minimal weight gain and metabolic changes, and substantial patient retention. These data reinforce OLZ/SAM as a valuable long-term treatment for patients with schizophrenia or BD-I.
Name of Sponsoring Organization(s): This study was sponsored by Alkermes, Inc. Medical writing and editorial support were provided by Peloton Advantage, LLC, an OPEN Health company, and funded by Alkermes, Inc.
METHODS: This updated review synthesizes the following clinical studies/analyses conducted over the past 5 years, providing a comprehensive overview of the OLZ/SAM clinical program. Effectiveness, safety, and tolerability of OLZ/SAM were assessed in a 12-week randomized double-blind study conducted in early-in-illness patients, a population at risk of antipsychotic-associated weight gain. A 4-year open-label extension study and subgroup analysis evaluated long-term safety and durability of treatment effect of OLZ/SAM in patients who completed prior studies. An individual patient data meta-analysis compared effects of OLZ/SAM versus olanzapine on weight gain using data from 3 clinical trials. A post hoc analysis explored effects of OLZ/SAM treatment on negative symptoms in patients with an acute exacerbation of schizophrenia. Patient retention rates were also summarized across the OLZ/SAM phase 3 clinical program.
RESULTS: OLZ/SAM treatment was associated with a durable antipsychotic treatment effect, clinically meaningful and durable improvement from baseline in the negative symptoms of schizophrenia, and minimal weight gain and metabolic changes for up to 5 years. Treatment with OLZ/SAM was well tolerated, and substantial retention rates were observed.
CONCLUSIONS: These data reinforce OLZ/SAM as a valuable long-term treatment option for patients with schizophrenia or BD-I.
Short Description: Combined olanzapine/samidorphan (OLZ/SAM) was approved by the US FDA in 2021 for the treatment of schizophrenia and bipolar I disorder (BD-I) and was accompanied by a clinical data review summarizing its efficacy/safety. This updated review synthesizes clinical studies/analyses from the past 5 years, with findings of durable treatment effect, minimal weight gain and metabolic changes, and substantial patient retention. These data reinforce OLZ/SAM as a valuable long-term treatment for patients with schizophrenia or BD-I.
Name of Sponsoring Organization(s): This study was sponsored by Alkermes, Inc. Medical writing and editorial support were provided by Peloton Advantage, LLC, an OPEN Health company, and funded by Alkermes, Inc.
