Lybalvi (olanzapine/samidorphan) / Alkermes - LARVOL DELTA

Healthcare Resource Utilization 12 Months Following Initiation of Olanzapine/Samidorphan: Real-World Assessment of Patients With Bipolar I Disorder (ISPOR 2025) - "Among patients with BD-I, OLZ/SAM initiation results in clinically meaningful reductions in disease burden, as evidenced by reductions in hospital-based HCRU. Longer OLZ/SAM treatment retention was associated with improved effectiveness."

Clinical • HEOR • Real-world • Real-world evidence • Bipolar Disorder • CNS Disorders • Psychiatry

Healthcare Resource Utilization 12 Months Following Initiation of Olanzapine/Samidorphan: Real-World Assessment of Patients With Schizophrenia (ISPOR 2025) - "Among patients with schizophrenia, OLZ/SAM initiation may result in clinically meaningful reductions in real-world disease burden, as evidenced by reductions in hospital-based HCRU. Longer treatment retention was associated with improved effectiveness."

Clinical • HEOR • Real-world • Real-world evidence • CNS Disorders • Psychiatry • Schizophrenia

A pharmacovigilance study of olanzapine/samidorphan based on FDA Adverse Event Reporting System (FAERS). (PubMed, BMC Pharmacol Toxicol) - "The long-term safety of the OLZ/SAM warrants attention, particularly concerning drug withdrawal syndrome."

Adverse events • Journal • Addiction (Opioid and Alcohol) • CNS Disorders

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2024 and Provides Financial Expectations for 2025 (PRNewswire) - "'This year, we have clear objectives for our pipeline as we complete the phase 2 studies for ALKS 2680 in narcolepsy, with data expected in the second half of the year, and prepare to initiate the ALKS 2680 phase 2 study in idiopathic hypersomnia...LYBALVI: Revenues for the fourth quarter were $77.0 million. Fourth quarter revenues and total prescriptions grew 37% and 30%, respectively, compared to the fourth quarter of 2023...ARISTADA: Revenues for the fourth quarter were $96.6 million. Fourth quarter revenues grew 16% compared to the fourth quarter of 2023...VIVITROL: Revenues for the fourth quarter were $134.1 million. Fourth quarter revenues grew 31% compared to the fourth quarter of 2023."

Commercial • New P2 trial • P2 data • Bipolar Disorder • CNS Disorders • Narcolepsy • Schizophrenia • Sleep Disorder

Olanzapine/Samidorphan Effects on Weight Gain: An Individual Patient Data Meta-Analysis of Phase 2 and 3 Randomized Double-Blind Studies. (PubMed, J Clin Psychiatry) - "Fewer patients treated with OLZ/SAM gained ≥7% (23.9% vs 34.6%; odds ratio [OR] = 0.58; 95% CI, 0.043-0.79) or ≥10% (13.7% vs 20.4%; OR = 0.60; 95% CI, 0.42-0.88) of their baseline body weight at week 12. In this IPD meta-analysis, OLZ/SAM treatment was associated with less weight gain and reduced risk of reaching ≥7% or ≥10% gain in body weight versus olanzapine over 12 weeks."

Clinical • Journal • P2 data • Retrospective data • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia

Exercise and Olanzapine-samidorphan (clinicaltrials.gov) - P4 | N=30 | Not yet recruiting | Sponsor: New York State Psychiatric Institute

New P4 trial • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia

Long-Term Safety, Tolerability, and Durability of Treatment Effect of Olanzapine and Samidorphan: Results of a 4-Year Open-Label Study. (PubMed, J Clin Psychiatry) - P3 | " OLZ/SAM maintained symptom control with a long-term safety profile over 4 years consistent with that of prior studies. Trials Registration: ClinicalTrials.gov identifier: NCT03201757."

Journal • Bipolar Disorder • CNS Disorders • Insomnia • Mood Disorders • Pain • Psychiatry • Schizophrenia • Schizophreniform Disorder • Sleep Disorder

Olanzapine and Samidorphan in Pediatric Patients With Bipolar I Disorder: Pharmacokinetic Results From a Phase 1, Multidose, Open-Label Study (AACAP 2024) - P1 | "In pediatric patients with stable BD-I, OLZ/SAM was generally well tolerated, consistent with findings in adults. Olanzapine exposure increased dose-proportionally and was higher in pediatric patients than it was observed in adults, likely due to body weight differences. Samidorphan exposure was comparable with that in adults.BRD, PKS, APS"

Clinical • P1 data • PK/PD data • Bipolar Disorder • CNS Disorders • Depression • Fatigue • Mood Disorders • Pain • Pediatrics • Psychiatry • Schizophrenia

A Phase III Clinical Study to Evaluate the Safety and Efficacy of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia (clinicaltrials.gov) - P3 | N=654 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P3 trial • CNS Disorders • Psychiatry • Schizophrenia

Real-World Effectiveness, Economic, and Humanistic Outcomes of Selected Oral Antipsychotics in Patients with Schizophrenia: A Systematic Review Evaluating Global Evidence. (PubMed, Clinicoecon Outcomes Res) - "Our systematic review aimed to synthesize literature describing real-world effectiveness, economic, and humanistic outcomes of OATs (asenapine, brexpiprazole, cariprazine, iloperidone, lumateperone, lurasidone, olanzapine/samidorphan, paliperidone, and quetiapine) for successful management of the disease. Medication non-adherence and treatment discontinuation were predominant factors contributing to the economic burden of schizophrenia. Our research showcased a significant knowledge gap across OATs spanning the humanistic and behavioral outcomes and medication adherence and switching, suggesting a need for robust evidence generation to help clinicians and payers make informed decisions regarding treatment opportunities and cost-effective strategies for patients with schizophrenia."

Journal • Real-world • Real-world effectiveness • Real-world evidence • Review • CNS Disorders • Psychiatry • Schizophrenia

Long-Term Safety and Efficacy of Olanzapine/Samidorphan: Results of a 4-Year Open-Label Study (ASCP 2024) - P3 | "Of 524 patients enrolled in the study, 523 received ≥1 dose of OLZ/SAM. 188 (35.9%) patients completed between 2 to 4 years of treatment. The mean (SD) duration of exposure was 652.4 (454.8) days."

Clinical • Bipolar Disorder • CNS Disorders • Insomnia • Mood Disorders • Pain • Psychiatry • Schizophrenia • Schizophreniform Disorder • Sleep Disorder

Long-term Safety and Efficacy of Olanzapine/Samidorphan: Results of a 4-Year Open-Label Study (APA 2024) - P3 | "In this 4-year open-label extension study, treatment with OLZ/SAM resulted in a safety profile consistent with previous short-term studies and was associated with minimal changes in body weight, waist circumference, and lipid and glycemic parameters. Similarly, OLZ/SAM maintained symptom control during long-term treatment. Based on these results, OLZ/SAM maintained long-term antipsychotic efficacy while mitigating the weight gain and metabolic dysfunction associated with olanzapine."

Clinical • Bipolar Disorder • CNS Disorders • Dyslipidemia • Insomnia • Metabolic Disorders • Mood Disorders • Pain • Psychiatry • Schizophrenia • Schizophreniform Disorder • Sleep Disorder

Healthcare Resource Utilization Following 6 Months of Treatment With Olanzapine/Samidorphan: Real-World Assessment of Patients With Schizophrenia or Bipolar I Disorder (ISPOR 2024) - "Among patients with SZ or BD-I, real-world OLZ/SAM initiation was associated with significant reductions in proportions of patients with all-cause and mental health–related hospitalizations and ED visits, indicating that OLZ/SAM may result in clinically meaningful reductions in disease burden, as evidenced by changes in inpatient care."

Clinical • HEOR • Real-world • Real-world evidence • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia

Treating Schizophrenia and Bipolar I Disorder in the Real-World Setting: Effectiveness and Safety of Olanzapine/Samidorphan Combination. (PubMed, Prim Care Companion CNS Disord) - No abstract available

Journal • Real-world • Real-world evidence • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia

Drugs for bipolar disorder. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

Health care resource utilization following 6 months of treatment with olanzapine/ samidorphan: Real-world assessment of patients with schizophrenia or bipolar I disorder (AMCP 2024) - "This is the first real-world study to assess HCRU 6 months before and after OLZ/SAM initiation. Among patients with SZ or BD-I, OLZ/SAM initiation was associated with significant reductions in the proportions of patients with all-cause and mental health–related hos- pitalizations and ED visits. Findings indicate that OLZ/SAM may result in clinically meaningful reductions in patient and provider burden, as evidenced by changes in inpatient care."

Clinical • HEOR • Real-world • Real-world evidence • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia

Healthcare Resource Utilization Following 6 Months of Treatment With Olanzapine/Samidorphan: Real-World Assessment of Patients With Schizophrenia or Bipolar I Disorder (AAPP 2024) - No abstract available

Clinical • HEOR • Real-world • Real-world evidence • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia

Olanzapine-Samidorphan for Schizophrenia: A Systematic Review and Meta-Analysis. (PubMed, Indian J Psychol Med) - "Drug discontinuation incidence was higher in the OLZSAM group: RR = 1.22; 95% CI = 0.84-1.79; p = 0.30. The combination OLZSAM showed comparable efficacy to olanzapine alone in schizophrenia patients, with relatively less incidence of weight gain and adverse events; however, the drug discontinuation due to adverse events was more in the OLZSAM group."

Journal • Retrospective data • Review • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia

Long-Term Safety and Efficacy of Olanzapine/Samidorphan: Results of a 4-Year Open-Label Study (SIRS 2024) - P3 | "Of 524 patients enrolled in the study, 523 received ≥1 dose of OLZ/SAM, and 188 (35.9%) completed the 4-year treatment period (mean [SD] duration of exposure=652.4 [454.8] days). Patients were mostly male (61.6%) and White (72.7%), with a mean (SD) age of 35.1 (12.2) years. Overall, 60.0% of patients reported an AE; the most common were weight increase (9.8%), headache (7.1%), anxiety (6.1%), insomnia (5.9%), somnolence (5.9%), nausea (5.7%), and weight decrease (5.7%)."

Clinical • CNS Disorders • Schizophrenia • Schizophreniform Disorder

A systematic review of the real-world effectiveness and economic and humanistic outcomes of selected oral antipsychotics among patients with schizophrenia in the United States: Updating the evidence and gaps. (PubMed, J Manag Care Spec Pharm) - "To review existing evidence and gaps regarding real-world effectiveness and economic and humanistic outcomes of OATs, including asenapine, brexpiprazole, cariprazine, iloperidone, lumateperone, lurasidone, olanzapine/samidorphan, paliperidone, and quetiapine. Our findings also suggest an unmet need regarding treatment nonadherence and lack of persistence among patients receiving OATs. We identified a need for research addressing OATs' behavioral and humanistic outcomes and evaluating the impact of product switching in adults with schizophrenia in the United States, which could assist clinicians in promoting patient-centered care and help payers understand the total value of new antipsychotic drugs."

Journal • Real-world • Real-world effectiveness • Real-world evidence • Review • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia

Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 (clinicaltrials.gov) - P3 | N=524 | Completed | Sponsor: Alkermes, Inc. | Active, not recruiting ➔ Completed

Trial completion • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia • Schizophreniform Disorder

Alkermes Announces Topline Results From Long-Term, Open-Label Safety and Durability of Treatment Effect Study of LYBALVI (olanzapine and samidorphan) (PRNewswire) - P3 | N=236 | NCT04987229 | Sponsor: Alkermes, Inc. | "Alkermes plc...announced topline results from a phase 3, open-label extension study assessing the long-term safety, tolerability and durability of treatment effect of LYBALVI^® (olanzapine and samidorphan) in patients with schizophrenia, schizophreniform disorder or bipolar I disorder for up to four years of treatment, following treatment received in prior LYBALVI studies....The safety profile of LYBALVI was consistent with previous studies. Patients' symptoms of schizophrenia or bipolar I disorder remained stable with up to four years of treatment with LYBALVI, as measured by the Clinical Global Impression of Severity (CGI-S) scale (mean change from baseline in CGI-S score of -0.28). Long-term treatment with LYBALVI was associated with minimal changes in body weight (mean change from baseline of +1.47 kg) and waist circumference (observed mean change from baseline of +0.61 cm) with up to four years of treatment."

P3 data: top line • Bipolar Disorder • CNS Disorders • Schizophrenia

Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects (clinicaltrials.gov) - P3 | N=236 | Enrolling by invitation | Sponsor: Alkermes, Inc.

Trial completion date • Trial primary completion date • Bipolar Disorder • CNS Disorders • Pediatrics • Psychiatry • Schizophrenia

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (clinicaltrials.gov) - P3 | N=220 | Recruiting | Sponsor: Alkermes, Inc.

Trial completion date • Trial primary completion date • Bipolar Disorder • CNS Disorders • Pediatrics • Psychiatry • Schizophrenia

Olanzapine/Samidorphan Effects on Weight Gain: A Pooled Analysis of Phase 2 and 3 Randomized, Double-Blind Studies (ACNP 2023) - P2, P3 | "In this pooled post hoc analysis, treatment with OLZ/SAM was consistently associated with less weight gain and reduced odds of ≥7% or ≥10% weight gain at week 12 versus olanzapine."

P2 data • Retrospective data • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia