Samidorphan, which was developed by Alkermes, is an opioid receptor antagonist that has been co-formulated with olanzapine into a single-dose oral tablet to mitigate the risk of weight gain while providing the therapeutic effect of olanzapine. Olanzapine/samidorphan (LYBALVI) was recently approved in the USA for the treatment of schizophrenia and bipolar I disorder. This article summarizes the milestones in the development of samidorphan leading to this first approval of olanzapine/samidorphan.
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Olanzapine-Samidorphan for Schizophrenia: A Systematic Review and Meta-Analysis.
Indian J Psychol Med
January 2024
Dept. of Pharmacology, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India.
Background And Objective: United States Food and Drug Administration (USFDA) recently approved a novel combination of olanzapine-samidorphan (OLZSAM) for managing olanzapine-associated adverse events (weight gain) in adult patients with schizophrenia and bipolar disorder. To opine about the safety and efficacy of OLZSAM, authors performed a systematic review and meta-analysis to convene justifiable evidence.
Methods: A thorough literature search was performed through the databases Embase, Cochrane Library, PubMed, and clinicaltrials.
Novel Compounds in the Treatment of Schizophrenia-A Selective Review.
Brain Sci
August 2023
3rd Department of Academic Psychiatry, AHEPA General Hospital, 546 36 Thessaloniki, Greece.
Article Synopsis
- Schizophrenia is a long-term mental health condition that severely affects a person’s daily life, and treatments usually combine medication and therapy, but many patients do not respond well to existing options.
- Recent research has identified ten new drugs aimed at treating schizophrenia, including three that have been approved by the FDA, while others are still being tested in clinical trials.
- There is a need for more research to better understand the causes of schizophrenia and create effective treatments that address negative and cognitive symptoms without causing negative side effects from current medications.
Olanzapine/samidorphan combination consistently mitigates weight gain across various subgroups of patients.
CNS Spectr
August 2023
Alkermes Pharma Ireland Ltd., Dublin, Ireland.
Objective: A combination of olanzapine and the opioid receptor antagonist samidorphan (OLZ/SAM) has been approved in the United States for the treatment of adults with schizophrenia or adults with bipolar I disorder. In a phase 3 study in adults with schizophrenia (ENLIGHTEN-2), OLZ/SAM treatment was associated with significantly less weight gain compared with olanzapine. Prespecified subgroup analyses explored the consistency of the weight mitigation effect of OLZ/SAM vs olanzapine across demographic subgroups in ENLIGHTEN-2.
View Article and Find Full Text PDFOlanzapine/Samidorphan: A New Option for the Treatment of Adults With Schizophrenia or Bipolar I Disorder.
J Pharm Technol
October 2022
Department of Pharmacy Practice, Nova Southeastern University College of Pharmacy, Davie, FL, USA.
Objective: To review the pharmacology, pharmacokinetics, and efficacy and safety data of a combination of olanzapine and samidorphan (OLZ/SAM) for the treatment of schizophrenia and bipolar I disorder, which mitigates the possible unwanted side effects of weight gain associated with olanzapine (OLZ).
Data Sources: The review was done with a bibliographic survey of studies using MEDLINE/PubMed (January 1999-May 2021) database using the keywords olanzapine and samidorphan. Abstracts, scientific posters, and information from the manufacturer's product labeling were evaluated for inclusion.
Samidorphan/olanzapine combination therapy for schizophrenia: Efficacy, tolerance and adverse outcomes of regimen, evidence-based review of clinical trials.
Ann Med Surg (Lond)
July 2022
School of Pharmacy, Monash University, Jalan Lagoon Selatan, Bandar Sunway, 47500, Subang Jaya, Selangor, Malaysia.
Introduction: Schizophrenia is a complex medical illness characterized by hallucinations, delusions, and cognitive issues. Olanzapine, a second-generation antipsychotic widely prescribed for schizophrenia has proven to be efficacious, however, its use is associated with major adverse effects such as weight gain, metabolic syndrome and diabetes mellitus. Recently, FDA approved a combination dose of olanzapine and samidorphan (OLZ/SAM) to mitigate the adverse outcomes associated with olanzapine use for the treatment of Schizophrenia.
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