{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T08:19:59Z","timestamp":1785831599181,"version":"3.56.0"},"reference-count":34,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2019,1,8]],"date-time":"2019-01-08T00:00:00Z","timestamp":1546905600000},"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":[[2019,6]]},"abstract":"<jats:p>Objective: To review the efficacy, safety, pharmacology and pharmacokinetics of pure, plant-derived cannabidiol (CBD; Epidiolex) in the treatment of Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). Data Sources: Relevant information was identified through EMBASE and Ovid MEDLINE (1946 to October 2018). Product labeling and https:\/\/www.clinicaltrials.gov were also reviewed. Study Selection\/Data Extraction: English language articles evaluating efficacy and safety in humans with treatment-resistant epilepsies were reviewed; additional pharmacology and pharmacokinetic studies in humans, animals, and in vitro were also included. Data Synthesis: Pure, plant-based CBD is a pharmaceutical grade extract that exhibits clinically significant antiseizure properties, with a hypothesized multimodal mechanism of action. In the GWPCARE trial series, CBD displayed superior efficacy in reducing key seizure frequencies (convulsive seizures in DS; drop seizures in LGS) by 17% to 23% compared with placebo as adjunctive therapy to standard antiepileptic drugs in patients 2 years of age and older. Common adverse effects were somnolence, diarrhea, and elevated hepatic transaminases. Noteworthy drug-drug interactions included clobazam, valproates, and significant inducers\/inhibitors of CYP2C19 and 3A4 enzymes. Relevance to Patient Care and Clinical Practice: A discussion regarding CBD dosing, administration, adverse effects, monitoring parameters, and interactions is provided to guide clinicians. CBD offers patients with DS and LGS a new treatment option for refractory seizures. Conclusion: This is the first cannabis-derived medication with approval from the US Food and Drug Administration. This CBD formulation significantly reduces seizures as an adjunct to standard antiepileptic therapies in patients \u22652 years old with DS and LGS and is well tolerated.<\/jats:p>","DOI":"10.1177\/1060028018822124","type":"journal-article","created":{"date-parts":[[2019,1,8]],"date-time":"2019-01-08T18:03:05Z","timestamp":1546970585000},"page":"603-611","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":74,"title":["Cannabidiol: A New Hope for Patients With Dravet or Lennox-Gastaut Syndromes"],"prefix":"10.1177","volume":"53","author":[{"given":"Jeffrey W.","family":"Chen","sequence":"first","affiliation":[{"name":"University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura M.","family":"Borgelt","sequence":"additional","affiliation":[{"name":"University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3126-4204","authenticated-orcid":false,"given":"Allison B.","family":"Blackmer","sequence":"additional","affiliation":[{"name":"University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2019,1,8]]},"reference":[{"key":"bibr1-1060028018822124","doi-asserted-by":"publisher","DOI":"10.1007\/s10072-017-3188-y"},{"key":"bibr2-1060028018822124","doi-asserted-by":"publisher","DOI":"10.1016\/j.pediatrneurol.2017.01.025"},{"key":"bibr3-1060028018822124","doi-asserted-by":"publisher","DOI":"10.1111\/epi.12631"},{"key":"bibr4-1060028018822124","volume-title":"Epilepsy and Other Chronic Convulsive Diseases: Their Causes, Symptoms, & Treatment","author":"Gowers WR.","year":"1881"},{"key":"bibr5-1060028018822124","volume-title":"Epilepsy: Its Symptoms, Treatment, and Relation to Other Chronic Convulsive Diseases","author":"Reynolds JR","year":"1861"},{"key":"bibr6-1060028018822124","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2016.11.016"},{"key":"bibr7-1060028018822124","unstructured":"National Conference of State Legislatures. State Medical Marijuana Laws. http:\/\/www.ncsl.org\/research\/health\/state-medical-marijuana-laws.aspx. Published August 11, 2018. Accessed September 20, 2018."},{"key":"bibr8-1060028018822124","unstructured":"Cannabinoid Medicines International Association for Cannabinoid Medicines. Laws and politics. http:\/\/cannabis-med.org\/index.php?tpl=page&id=41&lng=en&sid=1b35fdd1438521c70b7a145c6cf33ff. Accessed December 2, 2018."},{"key":"bibr9-1060028018822124","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1611618"},{"key":"bibr10-1060028018822124","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)30136-3"},{"key":"bibr11-1060028018822124","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1714631"},{"key":"bibr12-1060028018822124","unstructured":"US Food and Drug Administration. FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe form of epilepsy. https:\/\/www.fda.gov\/newsevents\/newsroom\/pressannouncements\/ucm611046.htm. Published June 25, 2018. Accessed September 26, 2018."},{"key":"bibr13-1060028018822124","unstructured":"GW Pharmaceuticals. GW Pharmaceuticals plc and its US Subsidiary Greenwich Biosciences announce the DEA has rescheduled Epidiolex\u00ae (cannabidiol) oral solution to schedule V. http:\/\/ir.gwpharm.com\/news-releases\/news-release-details\/gw-pharmaceuticals-plc-and-its-us-subsidiary-greenwich-0. Published September 27, 2018. Accessed December 14, 2018."},{"key":"bibr14-1060028018822124","unstructured":"GW Pharmaceuticals. GW Pharmaceuticals announces the European Medicines Agency (EMA) accepts Epidiolex\u00ae (cannabidiol) marketing authorization application (MAA) for review. https:\/\/www.gwpharm.com\/about\/news\/gw-pharmaceuticals-announces-european-medicines-agency-ema-accepts-epidiolexr. Published February 5, 2018. Accessed November 10, 2018."},{"key":"bibr15-1060028018822124","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(15)00379-8"},{"key":"bibr16-1060028018822124","doi-asserted-by":"publisher","DOI":"10.1111\/epi.14477"},{"key":"bibr17-1060028018822124","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2018.07.020"},{"key":"bibr18-1060028018822124","doi-asserted-by":"publisher","DOI":"10.1111\/epi.13815"},{"key":"bibr19-1060028018822124","doi-asserted-by":"publisher","DOI":"10.1177\/0883073816669450"},{"key":"bibr20-1060028018822124","doi-asserted-by":"publisher","DOI":"10.1111\/epi.13499"},{"key":"bibr21-1060028018822124","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2018.05.013"},{"key":"bibr22-1060028018822124","unstructured":"Epidiolex [package insert]. 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