Manuscripts and Presentations
The Latest
Joseph M Palumbo. Zygel™ (ZYN002) Development Program in Fragile X Syndrome. 17th NFXF International Fragile X Conference – Virtual series, Fragile X Research Roundup, July 22, 2020.
Zygel FXS Development Program
Most Recent
Joseph M Palumbo, Natalie Silove, Jonathan Cohen, Carol O’Neill, Nancy Tich, Wei Du, Helen Heussler. Cannabidiol Transdermal Gel for the Treatment of Fragile X Syndrome: Post Hoc Analysis of FAB-C and Pattern of Efficacy on Domains of the Aberrant Behavior Checklist-Community for FXS (ABC-CFXS) Through 116 Weeks of Treatment. American Academy of Neurology (AAN) Science Highlights Virtual Session, 2020.
Post Hoc Analysis: Fragile X Syndrome FAB-C
Ingrid Scheffer, Joseph Hulihan, John Messenheimer, Shayma Ali, Suzanne Davis, Donna Gutterman, Terri Sebree, Lynette Sadleir. Cannabidiol Transdermal Gel in Children and Adolescents With Developmental and Epileptic Encephalopathies: An Open-Label Clinical Trial (BELIEVE). American Academy of Neurology (AAN) Science Highlights Virtual Session, 2020.
DEE Efficacy
Lynette Sadleir, Joseph Hulihan, John Messenheimer, Shayma Ali, Donna Gutterman, Terri Sebree, Ingrid Scheffer. Quality of Life and Qualitative Caregiver Assessments in Children and Adolescents with Developmental and Epileptic Encephalopathies Treated With Cannabidiol Transdermal Gel: An Open-Label Clinical Trial (BELIEVE). American Academy of Neurology (AAN) Science Highlights Virtual Session, 2020.
DEE Quality of Life
Joseph M. Palumbo, Stephen O’Quinn, Nancy Tich, Jeffrey Zhang, Wendy Agnese. Post Hoc Analysis – An Open-Label Study of Transdermal Cannabidiol (ZYN002) for the Treatment of Fragile X Syndrome in Children and Adolescents: Estimating Health State Utility Scores. American Society for Experimental Neurotherapeutics (ASENT) 2020 Meeting. Bethesda, MD on March 2 – March 5, 2020
Post Hoc Analysis: Estimating Health State Utility Scores ASENT Data Blitz presentation
Joseph M. Palumbo, Jeffrey Zhang, Wendy Agnese. Fragile X Syndrome Diagnosis and Patient Journey: The Caregiver’s Perspective. American Society for Experimental Neurotherapeutics (ASENT) 2020 Meeting. Bethesda, MD on March 2 – March 5, 2020
Fragile X Syndrome Diagnosis and Patient Journey
Helen Heussler, Michael Duhig, Terry Hurst, Carol O’Neill, Wendy Agnese, Joseph M. Palumbo. Phase 2 BRIGHT (An Exploratory Open-Label Tolerability and Efficacy Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Autism Spectrum Disorder) Trial: Baseline Characteristics. American Society for Experimental Neurotherapeutics (ASENT) 2020 Meeting. Bethesda, MD on March 2 – March 5, 2020
Phase 2 BRIGHT Trial Baseline Characteristics ASENT Data Blitz presentation
Zygel™ (ZYN002 CBD Gel)
H. Heussler, J. Cohen, N. Silove, N. Tich, M. Bonn-Miller, W. Du, C. O’Neill, and T. Sebree. A Phase 1/2, Open-Label Assessment of the Safety, Tolerability, and Efficacy of Transdermal Cannabidiol (ZYN002) for the Treatment of Pediatric Fragile X Syndrome. Journal of Neurodevelopmental Disorders 2019; 11:16.
Journal Article PDF
H. Heussler, J. Cohen, N. Silove, N. Tich, T. Sebree, S. Siegel, and D. Gutterman. Transdermal Cannabidiol (CBD) Gel for the Treatment of Fragile X Syndrome (FXS). 2019 Annual Meeting of the American Psychiatric Association. San Francisco, CA. May 18-22, 2019.
Transdermal Cannabidiol (CBD) Gel for the Treatment of Fragile X Syndrome
H. Heussler, J. Cohen, N. Silove, N. Tich, T. Sebree, and S. Siegel. Transdermal Cannabidiol (CBD) Gel for the Treatment of Fragile X Syndrome (FXS). 57th Annual Meeting of the American College of Neuropsychopharmacology (ACNP). Hollywood, FL. December 9-12, 2018.
Transdermal Cannabidiol (CBD) Gel for the Treatment of Fragile X Syndrome
T. O’Brien, MD, FRACP; S. Berkovic, MD, FRACP; J. French; J. Messenheimer, MD; M. Bonn-Miller, PhD; and D. Gutterman, PharmD. Synthetic Transdermal Cannabidiol for the Treatment of Focal Epilepsy in Adults. American Epilepsy Society Annual Meeting 2018. New Orleans, LA. November 29-Dec. 4, 2018.
Synthetic Transdermal Cannabidiol for the Treatment of Focal Epilepsy in Adults
Gonzalez-Cuevas G, et al. Unique treatment potential of cannabidiol for the prevention of relapse to drug use: Preclinical proof of principal. Neuropsychopharmacology DOI: 10.1038/S41386-018-0050-8.
Please see the Springer Nature press release here.
CBD for prevention of relapse to drugs
H. Heussler, J. Cohen, N. Silove, N. Tich, T. Sebree, and S. Siegel. Transdermal Cannabidiol (CBD) Gel for the Treatment of Fragile X Syndrome (FXS). 16th NFXF (National Fragile X Foundation) International Fragile X Conference. Cincinatti, OH. July 12, 2018.
Presentation
Poster
O’Brien T MD, FRACP; Berkovic, S, MD, FRACP; French, J, MD, et al. Synthetic Transdermal Cannabidiol for the Treatment of Focal Epilepsy in Adults. 2017 American Epilepsy Society Annual Meeting, Washington, DC. December 1-5, 2017.
Synthetic Transdermal CBD in Adult Focal Epilepsy
Bonn-Miller M, Gutterman D. A Permeation-Enhanced Synthetic Cannabidiol (CBD) Transdermal Gel for the Treatment of PTSD. Military Health System Research Symposium. Orlando, FL. August 15-18, 2016.
CBD Gel for PTSD
Bonn-Miller M, Sebree T, O’Neill C, Messenheimer J. Neuropsychological Effects of ZYN002 (Synthetic Cannabidiol) Transdermal Gel in Healthy Subjects and Patients with Epilepsy: Phase 1, Randomized, Double-Blind, Placebo-Controlled Studies. American Epilepsy Society Annual Meeting. Houston, TX. December 2-6, 2016.
Neuropsychological Effects of ZYN002
Sebree T, O’Neill C, Messenheimer J, Gutterman D. Safety and Tolerability of ZYN002 (Synthetic Cannabidiol) Transdermal Permeation-Enhanced Gel in Healthy Subjects and Epilepsy Patients: Three Phase 1, Randomized, Double-Blind, Placebo-Controlled Studies. American Epilepsy Society Annual Meeting. Houston, TX. December 2-6, 2016.
ZYN002 Safety and Tolerability
Fragile X Syndrome
Elizabeth Merikle, Vanessa Patel, Terri Sebree, Carolyn Kreusser, and Helen H. Heussler. Content Validity in Support of the ABC-CFXS and Subscales in Fragile X Syndrome. The 22nd Society for the Study of Behavioural Phenotypes (SSBP) Symposium. Birmingham, UK on September 4 – 6, 2019.
Content Validity Supporting the ABC-C(FXS)
Jung KM, Sepers M, et al. Uncoupling of the endocannabinoid signalling complex in a mouse model of fragile X syndrome. Nat Commun 2012;3:1080.
Link to Article
Qin M, Zeidler Z, et al. Endocannabinoid-mediated improvement on a test of aversive memory in a mouse model of fragile X syndrome. Behav Brain Res 2015 Sep 15;291:164-71.
Link to Article
Epilepsy
Consroe P, Wolkin A. Cannabidiol–antiepileptic drug comparisons and interactions in experimentally induced seizures in rats. J Pharmacol Exp Ther. 1977 Apr;201(1):26-32.
Link to Article
Consroe P, Benedito MA, et al. Effects of cannabidiol on behavioral seizures caused by convulsant drugs or current in mice. Eur J Pharmacol. 1982 Sep 24;83(3-4):293-8.
Link to Article
Cunha JM, Carlini EA, et al. Chronic Administration of Cannabidiol to Healthy Volunteers and Epileptic Patients. Pharmacology 1980;21:175-185.
Link to Article
Devinsky O, Marsh E, et al. Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial. Lancet Neurol 2016; 15: 270–78.
Link to article
Friedman D and Devinsky O. Cannabinoids in the Treatment of Epilepsy. N Engl J Med 2015; 373:1048-1058.
Link to Article
Jones NA, Glyn SE, et al. Cannabidiol exerts anti-convulsant effects in animal models of temporal lobe and partial seizures. Seizure. 2012 Jun;21(5):344-52.
Link to Article
Jones NA, Hill AJ, Smith I, et al. Cannabidiol Display Antiepileptiform and Antiseizure Properties In Vitro and In Vivo. J Pharmac. and Exper. Therap. 2010;332(2):569-577.
Link to Article
Porter BE, Jacobson C. Report of a parent survey of cannabidiol-enriched cannabis use in pediatric treatment-resistant epilepsy. Epilepsy & Behavior 2013;29:574–577.
Link to Article
Autism Spectrum Disorder
Helen H. Heussler, Donna Gutterman, and Terri Sebree. Common Behavioral Features of Autism, Fragile X Syndrome, and 22q11.2 Deletion Syndrome. The 22nd Society for the Study of Behavioural Phenotypes (SSBP) Symposium. Birmingham, UK on September 4 – 6, 2019.
Common Behaviors of ASD, FXS and 22q11.2DS
Poleg S, Golubchik P, Offen D, Weizman A. Cannabidiol as a suggested candidate for treatment of autism spectrum disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2019;89:90-96.
Link to Article
Baumer N, Spence SJ. Evaluation and Management of the Child With Autism Spectrum Disorder. Continuum. 2018;24:248-275.
Link to Article
Wei D, Allsop S, Tye K, Piomelli D. Endocannabinoid Signaling in the Control of Social Behavior. Trends Neurosci. 2017;40(7):385-396.
Link to Article
22q11.2 Deletion Syndrome
McDonald-McGinn DM, Sullivan KE, Marino B, Philip N, Swillen A, Vorstman JA, Zackai EH, Emanuel BS, Vermeesch JR, Morrow BE, Scambler PJ, Bassett AS. 22q11.2 deletion syndrome. Nat Rev Dis Primers. 2015;1:15071.
Link to Article
Swillen A, McDonald-McGinn D. Developmental trajectories in 22q11.2 deletion. Am J Med Genet C Semin Med Genet. 2015;169(2):172-81.
Link to Article
Cannabinoids and Delivery Systems
R. Mannion. Cannabinoid Manufacturing & Product Quality. U.S. Food and Drug Administration’s Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds Public Hearing. Silver Spring, MD. May 31, 2019.
Zynerba presentation from FDA’s Cannabis or Cannabis-Derived Compounds public hearing
Merrick J, Lane B, Sebree T, Yaksh T, O’Neill C, Banks SL. Identification of psychoactive degradants of cannabidiol in simulated gastric and physiological fluid. Cannabis and Cannabinoid Research 2016;1:1, 102–112, DOI: 10.1089/can.2015.0004.
Link to Article
Bonn-Miller M, Banks SL, Sebree T. Conversion of Cannabidiol Following Oral Administration: Authors’ Response to Grotenhermen et al. Cannabis and Cannabinoid Research 2017;2:1, 5-7.
Link to Article
Paudel KS, Hammell DC, et al. Cannabidiol bioavailability after nasal and transdermal application: effect of permeation enhancers. Drug Development and Industrial Pharmacy 2010;36(9):1088–1097.
Link to Article