touchROUNDTABLE Apomorphine sublingual film for OFF episodes in Parkinson’s disease
In patients with Parkinson’s disease, an OFF episode typically refers to the recurrence of motor and nonmotor symptoms while receiving chronic levodopa-based therapy.1,2 Here we present a roundtable discussion between three leading experts on the use of apomorphine sublingual film for the treatment of OFF episodes, with reference to key clinical data.
Prof. Tanya Simuni
Northwestern University, Feinberg School of Medicine, Chicago, IL, USA
CHAIR
Panelists:
Introduction
Prof. Simuni introduces the expert faculty and provides an overview of the meeting’s objectives.
1/5 Next ChapterWhat are OFF episodes in Parkinson’s disease? How do they occur and how are they treated?
Prof. Simuni discusses what is meant by OFF episodes in Parkinson’s disease, how they occur, the impact on the patient and how they are treated.
2/5 Next ChapterWhat were the results of the randomized phase of the pivotal study (CTH-300) of APL?
Prof. Factor introduces APL and presents the key efficacy and safety data from the 12-week, randomized, double-blind, maintenance phase of the pivotal study (CTH-300).
3/5 Next ChapterWhat were the results of the open-label, dose-titration phase of the pivotal study (CTH-300) of APL?
Prof. Hui presents the dose-distribution, responder analysis and key efficacy and safety data from the open-label, dose-titration phase of the pivotal study (CTH-300) of APL.
4/5 Next ChapterGroup discussion
The expert faculty discuss their real-world experience with treating OFF episodes with APL.
5/5 Leave FeedbackOverview & Learning Objectives
Overview
Watch leading experts Tanya Simuni, Stewart Factor and Jennifer Hui discuss the use of apomorphine sublingual film (APL) for the treatment of OFF episodes in Parkinson’s disease, as well as key results from the pivotal study (CTH-300) of APL.
Learning Objectives
After watching this activity, participants should be better able to:
- Understand what is meant by OFF episodes in Parkinson’s disease and the purpose of on-demand therapy
- Understand the impact of OFF episodes from the patient’s perspective, and the importance of onset of effect for on-demand therapies
- Describe key safety and efficacy data from the pivotal study (CTH-300) of APL for the treatment of OFF episodes in Parkinson’s disease
Faculty & Disclosures
Prof. Tanya Simuni
Northwestern University, Feinberg School of Medicine, Chicago, IL, USA
Prof. Simuni heads the Northwestern University Feinberg School of Medicine Movement Disorders Centre that is recognized by both the Parkinson’s Foundation, Huntington’s disease, and Wilson’s Foundations as a Centre of Excellence. She is a world recognized expert in Parkinson’s disease modification studies and has acted as Principal Investigator or served as a Steering Committee member for many Parkinson’s disease clinical trials. Prof. Simuni is also an active member of the Movement Disorders Society, the International Association of Parkinsonism and Related Disorders, the American Academy of Neurology, American Neurological Association, as well as the Parkinson’s Study Group, and REM Behaviour Disorders Study Group. She has authored more than 100 publications in peer-reviewed scientific journals and book chapters, and she has lectured both nationally and internationally on Parkinson’s disease and other movement disorders.
Disclosures: Prof. Simuni is a paid consultant for Sunovion Pharmaceuticals Inc. Prof. Simuni has also received honoraria from speaking, advising, consulting, or providing educational programs for Acadia Pharmaceuticals Inc, Allergan Inc, Amneal Pharmaceuticals Inc (formerly Impax Laboratories), Aptinyx Inc, Denali Therapeutics, Department of Defense (DoD), GE Healthcare, Ketcham/Guenthner Group LLC, Kyowa Hakko Kirin Co Ltd, Leidos, Medlance, Movement Disorders Society, Roche, Sanofi Genzyme, Sinopia Biosciences Inc, Takeda Pharmaceuticals Inc, University of Louisville, University of Pennsylvania, and Voyager Therapeutics Inc. Prof. Simuni also has ownership or Investment Interests in Sinopia Biosciences Inc.
Prof. Stewart Factor
Emory University, Emory School of Medicine, Atlanta, GA, USA
Prof. Factor is Director of Movement Disorders and Vance Lanier Chair of Neurology at Emory University School of Medicine. He is a past Chair and Executive Committee Member of the Movement Disorders Section of the American Academy of Neurology, a member of the Movement Disorders Society education committee, and sit of the Executive Committee of the Parkinson’s Study Group. He has authored over 300 peer-reviewed publications and has edited multiple textbooks, including “Parkinson’s Disease: Diagnosis and Clinical Management” 1st and 2nd editions, “Drug-induced Movement Disorders” and “Therapy in Movement Disorders: A case-based approach”. His areas of research interest include Parkinson’s disease biomarkers, the freezing of gait in Parkinson’s disease, clinical trials, the genetics of Parkinson’s disease, and Tardive syndromes.
Disclosures: Prof. Factor is a paid consultant for Sunovion Pharmaceuticals Inc. Prof. Factor has also received honoraria from Acadia, Acorda, Biogen, CereSpir, Impel, and Lundbeck, Grants from Biohaven, Boston Scientific, CHDI Foundation, Impax, Jazz Pharmaceuticals, Lilly, Medtronics, Michael J. Fox Foundation, NIH(U10 NS077366), Parkinson Foundation, Sunovion Pharmaceuticals Inc, Therapeutics, US World Meds, Vaccinex, and Voyager. Royalties from Blackwell Futura, Demos, Springer for textbooks, UpToDate, and their disclosures include Bracket Global LLC, CNS Ratings LLC.
Prof. Jennifer Hui
University of California, Keck School of Medicine, Los Angeles, CA, USA
Prof. Hui is a board-certified neurologist specializing in behavioural neurology, Parkinson’s disease, and movement disorders. Her research focuses primarily on the non-motor manifestations of Parkinson’s disease, including compulsive behaviours, cognitive impairment, and depression. She is currently studying the behavioural side effects of medications used in the treatment of Parkinson’s disease, and the beneficial effects of exercise on cognition in Parkinson’s disease. Prof. Hui serves as the Site Investigator for several clinical trials studying new treatments for Parkinson’s disease and dystonia, as well as currently serving as Program Director of the Los Angeles County + University of Southern California Neurology Residency programme and the co-Director of the University of Southern California Deep Brain Stimulation programme.
Disclosures: Prof. Hui is a paid consultant for Sunovion Pharmaceuticals Inc. Prof. Hui has also received honoraria from speaking, advising, consulting, or providing research support Accorda Advisory Board, and Roche.
References
References
- Chou K. The spectrum of OFF in Parkinson’s disease: What have we learned over 40 years? Park Rel Disord. 2018;51:9–16.
- Storch A, Schneider CB, Wolz M, et al. Nonmotor fluctuations in Parkinson disease: severity and correlation with motor complications. Neurology. 2013;80:800–9.
- Olanow CW, et al. Efficacy, safety and tolerability study of APL-130277 for the acute treatment of OFF episodes in patients with Parkinson’s disease. Lancet Neurol. 2020;19:135-144. [NCT024609090].
- Hui JS, et al. Open-label titration of apomorphine sublingual film in patients with Parkinson’s disease and OFF episodes. Park Rel Disord. 2020;79:110-116.