Poster
75
(#75) Safety, Tolerability, and Durability of Treatment Effect of Olanzapine and Samidorphan: A Patient Subgroup Analysis of a 4-Year Open-Label Study
Psych Congress 2025
Abstract: INTRODUCTION: This analysis examined subgroup data from a 4-year, open-label study of combined olanzapine/samidorphan (OLZ/SAM) in adults with schizophrenia, schizophreniform disorder, or bipolar I disorder.
METHODS: Patients completing studies in the ENLIGHTEN clinical trial program were eligible to receive ≥2 and up to 4 years of additional treatment in a phase 3, open-label study assessing OLZ/SAM's safety, tolerability, and durability of treatment effect. Prespecified subgroup analyses were conducted by age (18-29 or ≥30 years), sex (male or female), race (Black/African American or non-Black/African American), baseline body mass index (BMI; 25 or ≥25 kg/m2), and geographic region (US or non-US). Safety assessments included changes from baseline in body weight and waist circumference and adverse event (AE) incidences. Durability of treatment effect was assessed using the Clinical Global Impressions-Severity (CGI-S) scale.
RESULTS: Overall, 523 patients were included; 53.7% (242/451) and 32.5% (109/335) received 2 and 4 years of treatment, respectively. At 2 years, OLZ/SAM treatment was associated with small mean changes from baseline in body weight (range: 0-2.15 kg) and minimal mean changes in waist circumference (range: −1.13-0.15 cm) across subgroups. Mean changes in body weight (range: 1.51-5.49 kg) and waist circumference (range: 0.67-3.85 cm) were generally similar across subgroups at 4 years. No clinically meaningful subgroup differences in AEs were observed. Mean CGI-S scale scores were stable across subgroups at 2 and 4 years.
CONCLUSIONS: Outcomes following up to 4 years of OLZ/SAM treatment were generally similar across age, sex, race, BMI, and geographic subgroups.
Short Description: This analysis examined safety/effectiveness subgroup data from a 4-year open-label study of combined olanzapine/samidorphan (OLZ/SAM) in adults with schizophrenia, schizophreniform disorder, or bipolar I disorder. Across age, sex, race, body mass index, and geographic region subgroups, OLZ/SAM was associated with minimal changes in body weight and stable symptoms. No meaningful differences in adverse events were observed among subgroups. OLZ/SAM has a consistent safety profile and durable treatment effect across diverse patient populations during long-term treatment.
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: Patients completing studies in the ENLIGHTEN clinical trial program were eligible to receive ≥2 and up to 4 years of additional treatment in a phase 3, open-label study assessing OLZ/SAM's safety, tolerability, and durability of treatment effect. Prespecified subgroup analyses were conducted by age (18-29 or ≥30 years), sex (male or female), race (Black/African American or non-Black/African American), baseline body mass index (BMI; 25 or ≥25 kg/m2), and geographic region (US or non-US). Safety assessments included changes from baseline in body weight and waist circumference and adverse event (AE) incidences. Durability of treatment effect was assessed using the Clinical Global Impressions-Severity (CGI-S) scale.
RESULTS: Overall, 523 patients were included; 53.7% (242/451) and 32.5% (109/335) received 2 and 4 years of treatment, respectively. At 2 years, OLZ/SAM treatment was associated with small mean changes from baseline in body weight (range: 0-2.15 kg) and minimal mean changes in waist circumference (range: −1.13-0.15 cm) across subgroups. Mean changes in body weight (range: 1.51-5.49 kg) and waist circumference (range: 0.67-3.85 cm) were generally similar across subgroups at 4 years. No clinically meaningful subgroup differences in AEs were observed. Mean CGI-S scale scores were stable across subgroups at 2 and 4 years.
CONCLUSIONS: Outcomes following up to 4 years of OLZ/SAM treatment were generally similar across age, sex, race, BMI, and geographic subgroups.
Short Description: This analysis examined safety/effectiveness subgroup data from a 4-year open-label study of combined olanzapine/samidorphan (OLZ/SAM) in adults with schizophrenia, schizophreniform disorder, or bipolar I disorder. Across age, sex, race, body mass index, and geographic region subgroups, OLZ/SAM was associated with minimal changes in body weight and stable symptoms. No meaningful differences in adverse events were observed among subgroups. OLZ/SAM has a consistent safety profile and durable treatment effect across diverse patient populations during long-term treatment.
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.
