{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,4]],"date-time":"2026-07-04T23:03:09Z","timestamp":1783206189758,"version":"3.54.6"},"reference-count":22,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2024,4,29]],"date-time":"2024-04-29T00:00:00Z","timestamp":1714348800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Cenobamate is approved for the treatment of focal seizures in adults and is currently available as an oral tablet. Alternative methods of drug administration are needed for patients who are unable to swallow whole intact tablets. This phase 1, open\u2010label, randomized, single\u2010dose, three\u2010way crossover (3\u2010period, 3\u2010treatment, 6\u2010sequence) study (NCT05572255), conducted in healthy volunteers, assessed the relative bioavailability of a crushed 200\u2010mg cenobamate tablet administered orally or via nasogastric (NG) tube compared with an intact 200\u2010mg tablet. Each treatment was separated by a 13\u2010day washout period. Plasma samples for cenobamate concentration analysis were collected pre\u2010dose and at multiple time points up to 264 h post\u2010dose. Standard bioequivalence study criteria were applied to the relative bioavailability assessments. All 90% confidence intervals of test\u2010to\u2010reference geometric mean ratios for cenobamate pharmacokinetic parameters (C<jats:sub>max<\/jats:sub>, AUC<jats:sub>last<\/jats:sub>, and AUC<jats:sub>inf<\/jats:sub>) were within 85\u2010110% (predefined limit, 80\u2010125%), suggesting no difference in cenobamate exposures following administration of an intact tablet orally or a crushed tablet orally or via NG tube. All treatment\u2010emergent adverse events (TEAEs) were classified as mild and resolved. There were no deaths or other serious AEs (SAEs), and no TEAEs led to discontinuation. Our results indicate that the administration of cenobamate as a crushed tablet taken orally or via an NG tube can provide additional flexibility when patients cannot swallow intact tablets. Based on the results of this study, cenobamate is now approved by FDA to be taken whole or the tablets can be crushed. The crushed tablet can be mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube.<\/jats:p>","DOI":"10.1002\/jcph.2439","type":"journal-article","created":{"date-parts":[[2024,4,29]],"date-time":"2024-04-29T13:13:45Z","timestamp":1714396425000},"page":"922-931","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Relative Bioavailability of Cenobamate Administered as a Crushed Tablet, Either Orally or via Nasogastric Tube, versus an Intact Whole Tablet"],"prefix":"10.1002","volume":"64","author":[{"given":"Vijay","family":"Vashi","sequence":"first","affiliation":[{"name":"SK Life Science, Inc.  Paramus NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janice","family":"Laramy","sequence":"additional","affiliation":[{"name":"SK Life Science, Inc.  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Paramus NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan","family":"Hand","sequence":"additional","affiliation":[{"name":"Worldwide Clinical Trials  San Antonio TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,4,29]]},"reference":[{"key":"e_1_2_10_2_1","volume-title":"XCOPRI\u00ae (cenobamate tablets), for oral use, CV","year":"2024"},{"key":"e_1_2_10_3_1","volume-title":"Ontozry [summary of product characteristics]","year":"2023"},{"key":"e_1_2_10_4_1","unstructured":"Health Canada Drug and Health Product Portal.Regulatory Decision Summary for Xcopri.2023. Accessed December 14 2023.https:\/\/dhpp.hpfb\u2010dgpsa.ca\/review\u2010documents\/resource\/RDS1693578801415"},{"key":"e_1_2_10_5_1","unstructured":"Endo Ventures Ltd.XCOPRI cenobamate tablets Tablets 12.5 mg 25 mg 50 mg 100 mg 150 mg 200 mg oral. Antiepileptic agent. [product monograph].2023. 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