Abstracts
3427227
(#59) Olanzapine and Samidorphan in Adults With Schizophrenia or Bipolar I Disorder: Updated Review of Clinical Data
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: This review summarizes the past 5 years of clinical data evaluating combined olanzapine/samidorphan (OLZ/SAM) for the treatment of schizophrenia and bipolar I disorder. Across randomized, open-label, and meta-analytic studies, OLZ/SAM treatment was associated with a durable antipsychotic treatment effect, clinically meaningful improvement in negative symptoms of schizophrenia, and minimal weight gain. Treatment was well tolerated, and substantial study retention rates were observed. These data reinforce OLZ/SAM as a valuable long-term treatment option.
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: This review summarizes the past 5 years of clinical data evaluating combined olanzapine/samidorphan (OLZ/SAM) for the treatment of schizophrenia and bipolar I disorder. Across randomized, open-label, and meta-analytic studies, OLZ/SAM treatment was associated with a durable antipsychotic treatment effect, clinically meaningful improvement in negative symptoms of schizophrenia, and minimal weight gain. Treatment was well tolerated, and substantial study retention rates were observed. These data reinforce OLZ/SAM as a valuable long-term treatment option.
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.
