{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,12]],"date-time":"2026-07-12T02:02:14Z","timestamp":1783821734181,"version":"3.55.0"},"reference-count":31,"publisher":"SAGE Publications","issue":"9","license":[{"start":{"date-parts":[[2022,1,18]],"date-time":"2022-01-18T00:00:00Z","timestamp":1642464000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To describe the approval of olanzapine\/samidorphan, compare the clinical trial data, and summarize key findings, with a focus on impact to clinical practice.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Sources<\/jats:title>\n                    <jats:p>\n                      A literature search of PubMed was performed (March 2006 to November 2021) using the following search terms:\n                      <jats:italic toggle=\"yes\">Lybalvi, olanzapine\/samidorphan, olanzapine, antipsychotic, bipolar disorder, and schizophrenia<\/jats:italic>\n                      . Product monographs, review articles, and randomized control trials were reviewed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Selection and Data Extraction<\/jats:title>\n                    <jats:p>Relevant English-language studies conducted in humans were considered. Primary use of Phase III clinical drug approval trials preferred; supplementary trial analysis evaluated to provide context.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Synthesis<\/jats:title>\n                    <jats:p>\n                      In June 2021, the Food and Drug Administration (FDA) approved Lybalvi\n                      <jats:sup>\u00ae<\/jats:sup>\n                      (olanzapine\/samidorphan) for indications including treatment of adults with schizophrenia and\/or bipolar I disorder (acute manic episodes or acute episodes with mixed features) through the multi-stage ENLIGHTEN clinical trials. Participants were enrolled in 4-week, 24-week, and 52-week studies to evaluate the safety and efficacy of olanzapine\/samidorphan. Subsequent secondary analysis evaluated metabolic effects.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Relevance to Patient Care and Clinical Practice<\/jats:title>\n                    <jats:p>This review details the pharmacologic, pharmacokinetic, associated dosing and indications, and adverse effects for the drug combination olanzapine\/samidorphan. Better understanding of novel drug mechanisms will help to expand on the potential role and place for use in clinical practice.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>When treating complex patients with schizophrenia, the olanzapine\/samidorphan combination has limited effect on medication-induced weight gain often associated with antipsychotic olanzapine monotherapy. Additional studies are needed to further define the role of olanzapine\/samidorphan in bipolar I disorder and clinical practice.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280211070330","type":"journal-article","created":{"date-parts":[[2022,1,18]],"date-time":"2022-01-18T05:52:33Z","timestamp":1642485153000},"page":"1049-1057","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":24,"title":["Olanzapine\/Samidorphan: New Drug Approved for Treating Bipolar I Disorder and Schizophrenia"],"prefix":"10.1177","volume":"56","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2333-6917","authenticated-orcid":false,"given":"Christie","family":"Monahan","sequence":"first","affiliation":[{"name":"Departments of Pharmacotherapy &amp; Translational Research and Community Health &amp; Family Medicine, College of Pharmacy and Medicine, University of Florida, Gainesville, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lindsey","family":"McCoy","sequence":"additional","affiliation":[{"name":"Departments of Pharmacotherapy &amp; Translational Research and Community Health &amp; Family Medicine, College of Pharmacy and Medicine, University of Florida, Gainesville, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0902-5031","authenticated-orcid":false,"given":"Jason","family":"Powell","sequence":"additional","affiliation":[{"name":"Departments of Pharmacotherapy &amp; Translational Research and Community Health &amp; Family Medicine, College of Pharmacy and Medicine, University of Florida, Gainesville, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John G.","family":"Gums","sequence":"additional","affiliation":[{"name":"Departments of Pharmacotherapy &amp; Translational Research and Community Health &amp; Family Medicine, College of Pharmacy and Medicine, University of Florida, Gainesville, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2022,1,18]]},"reference":[{"key":"e_1_3_3_2_2","first-page":"20","volume-title":"The Global Burden of Disease","author":"Murray CJL","unstructured":"Murray CJL, Lopez AD. Disability: the invisible burden. In: Murray CJL, Lopez AD, eds. The Global Burden of Disease. Cambridge, MA: Harvard University Press; 1996:20-22."},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1093\/epirev\/mxn001."},{"key":"e_1_3_3_4_2","volume-title":"NIH Curriculum Supplement Series","author":"Biological Sciences Curriculum Study","year":"2007","unstructured":"Biological Sciences Curriculum Study. NIH Curriculum Supplement Series. Bethesda, MD: National Institutes of Health; 2007."},{"key":"e_1_3_3_5_2","volume-title":"Pharmacotherapy: A Pathophysiologic Approach","author":"Crismon M","year":"2020","unstructured":"Crismon M, Smith T, Buckley PF. Schizophrenia. In: DiPiro JT, Yee GC, Posey L, Haines ST, Nolin TD, Ellingrod V, eds. Pharmacotherapy: A Pathophysiologic Approach, 11th ed. McGraw Hill; 2020:1091-1124.","edition":"11"},{"key":"e_1_3_3_6_2","unstructured":"Diagnostic and Statistical Manual of Mental Disorder Fifth Edition (DSM-5). 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