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Long-term safety and tolerability of transdermal cannabidiol gel in children and adolescents with Fragile X syndrome (ZYN2-CL-017): an interim analysis of an ongoing open-label extension study.

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Title: Long-term safety and tolerability of transdermal cannabidiol gel in children and adolescents with Fragile X syndrome (ZYN2-CL-017): an interim analysis of an ongoing open-label extension study.
Authors: Berry-Kravis E; Departments of Pediatrics and Neurological Sciences, Rush University Medical Center, Chicago, IL, USA., Hagerman R; Medical Investigation of Neurodevelopmental Disorders (MIND) Institute, University of California Davis Medical Center, Sacramento, CA, USA.; Department of Pediatrics, University of California Davis School of Medicine, Sacramento, CA, USA., Cohen J; Fragile X Alliance Inc, North Caulfield, Melbourne, VIC, Australia.; Honorary Research Associate, Diagnosis and Development, Victorian Clinical Genetic Services and Murdoch Childrens Research Institute, Melbourne, VIC, Australia., Budimirovic D; Departments of Psychiatry and Child Psychiatry, Fragile X Clinic, Kennedy Krieger Institute/the Johns Hopkins Medical Institutions, Baltimore, MD, USA.; Department of Psychiatry & Behavioral Sciences-Child Psychiatry, Johns Hopkins School of Medicine, Baltimore, MD, USA., Buchanan CB; Greenwood Genetic Center, Greenville, SC, USA., Silove N; The Children's Hospital at Westmead, Sydney, Australia., Tich N; Harmony Biosciences, Plymouth Meeting, PA, USA., Thibodeau A; Harmony Biosciences, Plymouth Meeting, PA, USA., Dobbins T; The Griesser Group, Conshohocken, PA, USA., Sebree T; Pharmaceutical Consulting, LLC, Johnson City, TX, USA., O'Quinn S; Perissos Inc, Wake Forest, NC, USA., Albers DS; Harmony Biosciences, Plymouth Meeting, PA, USA., Bzdek KG; Harmony Biosciences, Plymouth Meeting, PA, USA. Publications@harmonybiosciences.com., Nomikos G; Harmony Biosciences, Plymouth Meeting, PA, USA., Budur K; Harmony Biosciences, Plymouth Meeting, PA, USA.
Source: Journal of neurodevelopmental disorders [J Neurodev Disord] 2025 Nov 18; Vol. 17 (1), pp. 69. Date of Electronic Publication: 2025 Nov 18.
Publication Type: Journal Article; Randomized Controlled Trial
Journal Info: Publisher: BioMed Central Country of Publication: England NLM ID: 101483832 Publication Model: Electronic Cited Medium: Internet ISSN: 1866-1955 (Electronic) Linking ISSN: 18661947 NLM ISO Abbreviation: J Neurodev Disord Subsets: MEDLINE
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  Data: Long-term safety and tolerability of transdermal cannabidiol gel in children and adolescents with Fragile X syndrome (ZYN2-CL-017): an interim analysis of an ongoing open-label extension study.
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  Data: <searchLink fieldCode="AU" term="%22Berry-Kravis+E%22">Berry-Kravis E</searchLink>; Departments of Pediatrics and Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.<br /><searchLink fieldCode="AU" term="%22Hagerman+R%22">Hagerman R</searchLink>; Medical Investigation of Neurodevelopmental Disorders (MIND) Institute, University of California Davis Medical Center, Sacramento, CA, USA.; Department of Pediatrics, University of California Davis School of Medicine, Sacramento, CA, USA.<br /><searchLink fieldCode="AU" term="%22Cohen+J%22">Cohen J</searchLink>; Fragile X Alliance Inc, North Caulfield, Melbourne, VIC, Australia.; Honorary Research Associate, Diagnosis and Development, Victorian Clinical Genetic Services and Murdoch Childrens Research Institute, Melbourne, VIC, Australia.<br /><searchLink fieldCode="AU" term="%22Budimirovic+D%22">Budimirovic D</searchLink>; Departments of Psychiatry and Child Psychiatry, Fragile X Clinic, Kennedy Krieger Institute/the Johns Hopkins Medical Institutions, Baltimore, MD, USA.; Department of Psychiatry & Behavioral Sciences-Child Psychiatry, Johns Hopkins School of Medicine, Baltimore, MD, USA.<br /><searchLink fieldCode="AU" term="%22Buchanan+CB%22">Buchanan CB</searchLink>; Greenwood Genetic Center, Greenville, SC, USA.<br /><searchLink fieldCode="AU" term="%22Silove+N%22">Silove N</searchLink>; The Children's Hospital at Westmead, Sydney, Australia.<br /><searchLink fieldCode="AU" term="%22Tich+N%22">Tich N</searchLink>; Harmony Biosciences, Plymouth Meeting, PA, USA.<br /><searchLink fieldCode="AU" term="%22Thibodeau+A%22">Thibodeau A</searchLink>; Harmony Biosciences, Plymouth Meeting, PA, USA.<br /><searchLink fieldCode="AU" term="%22Dobbins+T%22">Dobbins T</searchLink>; The Griesser Group, Conshohocken, PA, USA.<br /><searchLink fieldCode="AU" term="%22Sebree+T%22">Sebree T</searchLink>; Pharmaceutical Consulting, LLC, Johnson City, TX, USA.<br /><searchLink fieldCode="AU" term="%22O'Quinn+S%22">O'Quinn S</searchLink>; Perissos Inc, Wake Forest, NC, USA.<br /><searchLink fieldCode="AU" term="%22Albers+DS%22">Albers DS</searchLink>; Harmony Biosciences, Plymouth Meeting, PA, USA.<br /><searchLink fieldCode="AU" term="%22Bzdek+KG%22">Bzdek KG</searchLink>; Harmony Biosciences, Plymouth Meeting, PA, USA. Publications@harmonybiosciences.com.<br /><searchLink fieldCode="AU" term="%22Nomikos+G%22">Nomikos G</searchLink>; Harmony Biosciences, Plymouth Meeting, PA, USA.<br /><searchLink fieldCode="AU" term="%22Budur+K%22">Budur K</searchLink>; Harmony Biosciences, Plymouth Meeting, PA, USA.
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  Data: <searchLink fieldCode="JN" term="%22101483832%22">Journal of neurodevelopmental disorders</searchLink> [J Neurodev Disord] 2025 Nov 18; Vol. 17 (1), pp. 69. <i>Date of Electronic Publication: </i>2025 Nov 18.
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