Manuscripts and Presentations

The Latest

Helen Heussler, Michael Duhig, Jonathan Cohen, Caroline Buchanan, Carol O’Neill, Stephen O’Quinn. An Open-label Trial Assessing Short- and Long-term Tolerability and Efficacy of ZYN002 (Cannabidiol) Administered as a Transdermal Gel to Children and Adolescents with 22q11.2 Deletion Syndrome (INSPIRE). The Society for the Study of Behavioural Phenotypes (SSBP) 25^th International Research Symposium, September 15, 2023.
Presentation

Helen Heussler, Jonathan Cohen, Caroline Buchanan, Carol O’Neill, Stephen O’Quinn, Terri Sebree. An Open-Label Trial Assessing Short- and Long-Term Tolerability and Efficacy of ZYN002 (Cannabidiol) Administered as a Transdermal Gel to Children and Adolescents with 22q11.2 Deletion Syndrome (INSPIRE). American Society of Clinical Psychopharmacology Annual Meeting (ASCP 2023), May 31, 2023.
Poster

Nancy Tich, Anthony Thibodeau, Terri Sebree, Thomas Dobbins, Stephen O’Quinn. Long-term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in the Treatment of Behavioral Symptoms in Children and Adolescents with Fragile X Syndrome (ZYN2-CL-017). American Society of Clinical Psychopharmacology Annual Meeting (ASCP 2023), May 31, 2023.
Presentation

Nancy Tich, Anthony Thibodeau, Terri Sebree, Thomas Dobbins, Stephen O’Quinn. Long-term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome (ZYN2-CL-017). 55^th Gatlinburg Conference, April 2023.
Poster

Helen Heussler, Jonathan Cohen, Caroline Buchanan, Carol O’Neill, Terri Sebree, Stephen O’Quinn. An Open-Label Tolerability and Efficacy Study of ZYN002 (Cannabidiol) Administered as a Transdermal Gel to Children and Adolescents with 22q11.2 Deletion Syndrome (INSPIRE). 55th Gatlinburg Conference, April 2023.
Poster

Joseph M. Palumbo, Brian F. Thomas, Dejan Budimirovic, Steven Siegel, Flora Tassone, Randi Hagerman, Christopher Faulk, Stephen O’Quinn and Terri Sebree. Role of the endocannabinoid system in fragile X syndrome: potential mechanisms for benefit from cannabidiol treatment. Journal of Neurodevelopmental Disorders (2023) 15:1.
Publication

Helen Heussler, Jonathan Cohen, Caroline Buchanan, Carol O’Neill, Terri Sebree, Stephen O’Quinn, Steven Siegel. An Open-Label Tolerability and Efficacy Study of ZYN002 (Cannabidiol) Administered as a Transdermal Gel to Children and Adolescents with 22q11.2 Deletion Syndrome (INSPIRE). Annual Meeting of the American College of Neuropsychopharmacology, December 4-7, 2022.
Poster

Elizabeth Berry‑Kravis, Randi Hagerman, Dejan Budimirovic, Craig Erickson, Helen Heussler, Nicole Tartaglia, Jonathan Cohen, Flora Tassone, Thomas Dobbins, Elizabeth Merikle, Terri Sebree, Nancy Tich, Joseph M. Palumbo and Stephen O’Quinn. A randomized, controlled trial of ZYN002 cannabidiol transdermal gel in children and adolescents with fragile X syndrome (CONNECT‑FX). Journal of Neurodevelopmental Disorders (2022) 14:56.
Publication

Helen Heussler, Jonathan Cohen, Caroline Buchanan, Carol O’Neill, Terri Sebree, Stephen O’Quinn. An Open-Label, Tolerability and Efficacy Study of ZYN002 (Cannabidiol) Administered as a Transdermal Gel to Children and Adolescents with 22q11.2 Deletion Syndrome (INSPIRE). 2022 National Organization for Rare Disorders (NORD) Rare Diseases and Orphan Products Breakthrough Summit, October 17-18, 2022.
Poster

Helen Heussler, Jonathan Cohen, Caroline Buchanan, Carol O’Neill, Terri Sebree, Stephen O’Quinn. An Open-Label, Tolerability and Efficacy Study of ZYN002 (Cannabidiol) Administered as a Transdermal Gel to Children and Adolescents with 22q11.2 Deletion Syndrome (INSPIRE). The Society for the Study of Behavioural Phenotypes (SSBP) 24th International Research Symposium, September 8, 2022.
Presentation

Stephen O’Quinn. Development of ZYN002 (Zygel™) for the Treatment of Behavioral Symptoms in Fragile X Syndrome: Partnering to advance the care of children and adolescents with Fragile X Syndrome. 18th NFXF International Fragile X Conference, July 14-17, 2022.
Presentation

Nancy Tich, Terri Sebree, Thomas Dobbins, Elizabeth Merikle, Chris Brady, Stephen O’Quinn. RECONNECT (ZYN2-CL-033): Design of a Phase 3 Trial of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents With Fragile X Syndrome Based Upon Learnings From CONNECT-FX (ZYN2-CL-016). 18th NFXF International Fragile X Conference, July 14-17, 2022.
Poster

Nancy Tich, Anthony Thibodeau, Terri Sebree, Thomas Dobbins, Stephen O’Quinn. Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents With Fragile X Syndrome (ZYN2-CL-017). 18th NFXF International Fragile X Conference, July 14-17, 2022.
Poster

O’Brien TJ, Berkovic SF, French JA, Messenheimer JA, Sebree TB, Bonn-Miller MO, Gutterman DL; STAR 1/STAR 2 Study Group. Adjunctive Transdermal Cannabidiol for Adults With Focal Epilepsy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2220189. doi: 10.1001/jamanetworkopen.2022.20189.
Publication

Nancy Tich, Anthony Thibodeau, Joseph Palumbo, Thomas Dobbins, Stephen O’Quinn. Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome (ZYN2-CL-017). American Society of Clinical Psychopharmacology Annual Meeting (ASCP 2022), May 31 – June 3, 2022.
Presentation

Nancy Tich, Terri Sebree, Thomas Dobbins, Elizabeth Merikle, Chris Brady, Stephen O’Quinn. RECONNECT (ZYN2-CL-033): Design of a Phase 3 Trial of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome Based Upon Learnings from CONNECT-FX (ZYN2-CL-016) Completed During SARS-COV-2 Pandemic. American Society of Clinical Psychopharmacology Annual Meeting (ASCP 2022), May 31 – June 3, 2022.
Poster

Nancy Tich, Anthony Thibodeau, Joseph Palumbo, Thomas Dobbins, Stephen O’Quinn. Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome (ZYN2-CL-017). International Society for Autism Research Annual Meeting, May 2022.
Presentation

Nancy Tich, Anthony Thibodeau, Joseph Palumbo, Thomas Dobbins, Stephen O’Quinn. Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome (ZYN2-CL-017). 2022 Society of Biological Psychiatry Annual Meeting.
Poster

“The cannabis vanguard: A rare disease company looks to pioneer in the space.” A Q&A with Armando Anido, Chairman and Chief Executive Officer of Zynerba. PharmaVoice 2022.
Article

Stephen O’Quinn, PharmD. ZYN002 Cannabidiol Transdermal Gel Efficacy and Safety: Recent Clinical Research Advances in the Treatment of Autism and Fragile X Syndrome. BRAIN Foundation Synchrony 2021 Symposium.
Presentation

Zygel™ (ZYN002 CANNABIDIOL 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

Joseph M. Palumbo, Nancy Tich, Thomas Dobbins, Elizabeth Merikle, Stephen O’Quinn, Chris Brady, Terri Sebree. RECONNECT (ZYN2-CL-033): Design of a Phase 3 Trial of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome Based Upon Learnings from CONNECT-FX (ZYN2-CL-016). 68^th American Academy of Child & Adolescent Psychiatry (AACAP) Annual Meeting.
Presentation

Randi Hagerman, Elizabeth Berry-Kravis, Dejan Budimirovic, Craig Erickson, Helen Heussler, Nicole Tartaglia, Jonathan Cohen, Thomas Dobbins, Elizabeth Merikle, Terri Sebree, Nancy Tich, Joseph M. Palumbo. A Pivotal Study of ZYN002 Cannabidiol (CBD) Transdermal Gel in Children and Adolescents With Fragile X Syndrome [CONNECT-FX (ZYN2-CL-016)]. Society for Developmental & Behavioral Pediatrics (SDBP) Annual Meeting.
Presentation

Joseph M. Palumbo, Nancy Tich, Thomas Dobbins, Elizabeth Merikle, Stephen O’Quinn, Chris Brady, Terri Sebree. RECONNECT (ZYN2-CL-033): Design of a Phase 3 Trial of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome Based Upon Learnings from CONNECT-FX (ZYN2-CL-016). 2021 National Organization for Rare Disorders (NORD) Rare Diseases and Orphan Products Breakthrough Summit.
Poster

Randi Hagerman, Elizabeth Berry-Kravis, Dejan Budimirovic, Craig Erickson, Helen Heussler, Nicole Tartaglia, Jonathan Cohen, Thomas Dobbins, Elizabeth Merikle, Terri Sebree, Nancy Tich, Joseph M. Palumbo. A Pivotal Study of ZYN002 Cannabidiol (CBD) Transdermal Gel in Children and Adolescents With Fragile X Syndrome [CONNECT-FX (ZYN2-CL-016)]. The Society for the Study of Behavioural Phenotypes Conference 2021.
Podium presentation slides

Elizabeth Merikle, PhD, Vanessa Perez Patel, MS, PhD, Nancy Tich, MS, PhD, Terri Sebree, Randi Hagerman, MD, Joseph Palumbo, MD. Caregiver-Perceived Behavioral Challenges in Fragile X Syndrome (FXS) and their Measurement using the Aberrant Behavior Checklist-Community FXS Specific Scoring. International Society for Pharmacoeconomic and Outcomes Research (ISPOR) Virtual 2021 Conference.
Presentation

Elizabeth Merikle, Vanessa Perez Patel, Thomas Dobbins, Jim Griesser, Nancy Tich, Terri Sebree, Randi Hagerman, Joseph M. Palumbo. Meaningful Change Thresholds for the Aberrant Behavior Checklist-Community Fragile X Syndrome (ABC-C_FXS) in Children and Adolescents With FXS. International Society for Pharmacoeconomic and Outcomes Research (ISPOR) Virtual 2021 Conference.
Poster

Elizabeth Berry-Kravis, Randi Hagerman, Dejan Budimirovic, Craig Erickson, Helen Heussler, Nicole Tartaglia, Jonathan Cohen, Thomas Dobbins, Elizabeth Merikle, Terri Sebree, Nancy Tich, Joseph M. Palumbo. A Pivotal Study of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents With Fragile X Syndrome (CONNECT-FX [ZYN2-CL-016]). Society of Biological Psychiatry 2021 Virtual Meeting.
SOBP 2021 pivotal study poster

Elizabeth Merikle, Vanessa Perez Patel, Thomas Dobbins, Stephen O’Quinn, Nancy Tich, Joseph M. Palumbo. Cannabidiol in Fragile X Syndrome (FXS): Proposed Mechanism of Action Translates Into Meaningful Clinical Benefits (CONNECT-FX [ZYN2-CL-016]). Society of Biological Psychiatry (SOBP) 2021 Virtual Meeting.
SOBP 2021 clinical benefits poster

Joseph M. Palumbo, MD, FAPA, MACPsych. ZYN002 Cannabidiol Gel Efficacy and Safety: Recent Clinical Research Advances in the Experimental Treatment of Autism and Developmental and Epileptic Encephalopathies and the Role of Methylation Status as a Correlate of Disease Severity and Therapeutic Response in Fragile X Syndrome. The BRAIN Foundation2020 Synchrony Symposium, December 12, 2020.
2020 Synchrony podium presentation slides

Elizabeth Berry-Kravis, Craig Erickson, Randi Hagerman, Nicole Tartaglia, Jonathan Cohen, Terri Sebree,Donna Gutterman, Nancy Tich, Thomas Dobbins, Joseph M. Palumbo. ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents With Fragile X Syndrome: Role of Methylation Status as a Correlate to Disease Severity and as a Prognostic Biomarker. Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CNS) Meeting.
2020 CNS-ICNC annual meeting poster
2020 AACAP annual Meeting podium presentation slides

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

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

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

Elizabeth Merikle, Vanessa Patel, Terri Sebree, Carolyn Kreusser, and Helen H. Heussler. Content Validity in Support of the ABC-C_FXS 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 Heussler, Michael Duhig, Terry Hurst, Carol O’Neill, Donna Gutterman, Joseph M. Palumbo. Longer-Term Tolerability and Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents With Autism Spectrum Disorder: An Open-Label Phase 2 Study (BRIGHT [ZYN2-CL-030]). 68^th American Academy of Child & Adolescent Psychiatry (AACAP) Annual Meeting
Presentation

Helen Heussler, Michael Duhig, Terry Hurst, Carol O’Neill, Donna Gutterman, Joseph M. Palumbo, Terri Sebree. Longer Term Tolerability and Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Autism Spectrum Disorder (ASD): An Open-Label Phase 2 Study (BRIGHT [ZYN2-CL-030]). Society for Developmental & Behavioral Pediatrics (SDBP) Annual Meeting.
Poster

Helen Heussler, Michael Duhig, Terry Hurst, Carol O’Neill, Donna Gutterman, Joseph M. Palumbo. Longer Term Tolerability and Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Autism Spectrum Disorder (ASD): An Open-Label Phase 2 Study (BRIGHT [ZYN2-CL-030]). 2021 American Academy of Pediatrics (AAP) National Conference & Exhibition.
Poster

Helen Heussler, Michael Duhig, Terry Hurst, Carol O’Neill, Donna Gutterman, Joseph M. Palumbo. Longer Term Tolerability and Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Autism Spectrum Disorder (ASD): An Open-Label Phase 2 Study (BRIGHT [ZYN2-CL-030]). The Society for the Study of Behavioural Phenotypes Conference 2021.
Podium presentation slides

Joseph M Palumbo, Carol O’Neill, Nancy Tich, Donna Gutterman, Terry Hurst, Stephen O’Quinn. ZYN002 Cannabidiol Transdermal Gel: Efficacy and Safety Findings in Children and Adolescents With Autism Spectrum Disorder (ASD) and Related Disorders. 2021 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting.
Poster

Helen Heussler, Michael Duhig, Terry Hurst, Carol O’Neill, Donna Gutterman, Joseph M. Palumbo. Tolerability and Efficacy of ZYN002 Cannabidiol (CBD) Transdermal Gel in Children and Adolescents With Autism Spectrum Disorder: An Open-Label Phase 2 Study [BRIGHT (ZYN2-CL-030)]. Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CNS) Meeting.
2020 CNS-ICNC annual meeting poster
2020 AACAP annual Meeting podium presentation slides

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

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

Developmental and Epileptic Encephalopathies

Ingrid E. Scheffer, MBBS, PhD; Joe Hulihan, MD; John Messenheimer, MD; Shayma Ali, BSc; Ngaire Keenan, MBChB; Jim Griesser, MS; Donna L. Gutterman, PharmD; Terri Sebree, BS; Lynette G. Sadleir, MD, MBChB: Safety and Tolerability of Transdermal Cannabidiol Gel in Children With Developmental and Epileptic Encephalopathies; A Nonrandomized Controlled Trial. JAMA Network Open, 2021.
Publication

Joseph M Palumbo, Donna Gutterman, John Messenheimer, Stephen O’Quinn, Ingrid E Scheffer, Lynette G Sadleir. Impact of ZYN002 Cannabidiol Transdermal Gel on Sleep in Children and Adolescents with Developmental and Epileptic Encephalopathies and Comorbid Autism Spectrum Disorder. SLEEP 2021.
Poster

Ingrid E. Scheffer, MBBS, PhD; FRS, Joseph Hulihan, MD; John Messenheimer, MD; Shayma Ali, BSc; Ngaire Keenan, MBChB; Donna L. Gutterman, PharmD; Terri Sebree, BS; Lynette G. Sadleir, MBChB, MD. ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents With Developmental and Epileptic Encephalopathies: An Open-Label Clinical Trial [BELIEVE (ZYN2-CL-025)]. 2020 virtual annual meeting of the American Epilepsy Society (AES).
2020 AES BELIEVE trial poster

Lynette G Sadleir,MBChB, MD; Joseph Hulihan, MD; John Messenheimer, MD; ShaymaAli, BSc; Donna Gutterman, PharmD; Terri Sebree, BS; Ingrid E Scheffer, MBBS, PhD, FRS. Quality of Life and Sleep Assessments in Children with Developmental and Epileptic Encephalopathies Treated With ZYN002 (CBD) Transdermal Gel: BELIEVE (ZYN2-CL-025). 2020 virtual annual meeting of the American Epilepsy Society (AES).
2020 AES BELIEVE QoL and Sleep assessments poster

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

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