Professor of Neurology, Neurosurgery & Psychiatry; Director, NYU Comprehensive Epilepsy Center
NYU Langone Health · New York, NY
Orrin Devinsky is one of the world's foremost epileptologists and the clinical researcher most responsible for establishing CBD (Epidiolex) as an FDA-approved treatment for Dravet syndrome and Lennox-Gastaut syndrome. His pivotal Phase 3 trials, published in the New England Journal of Medicine and The Lancet Neurology, provided the rigorous clinical evidence that led to the first FDA approval of a cannabis-derived medicine in 2018. Devinsky has treated thousands of patients with treatment-resistant epilepsy and has been a tireless advocate for evidence-based access to cannabinoid medicines for children with severe epilepsy. He is a member of the National Academy of Medicine and has received the American Epilepsy Society's Lifetime Achievement Award.
New England Journal of Medicine · 2017
Landmark Phase 3 RCT of CBD (20mg/kg/day) in 120 children with Dravet syndrome. CBD reduced convulsive seizure frequency by 39% vs. 13% for placebo (p=0.01). 5% of CBD patients became seizure-free vs. 0% placebo. This trial led directly to FDA approval of Epidiolex.
DOI: 10.1056/NEJMoa1611618New England Journal of Medicine · 2018
Phase 3 RCT of CBD for Lennox-Gastaut syndrome. CBD reduced drop seizure frequency by 43.9% vs. 21.8% for placebo. Results supported FDA approval of Epidiolex for LGS, expanding the approved indication beyond Dravet syndrome.
DOI: 10.1056/NEJMoa1714631The Lancet Neurology · 2016
Open-label trial of CBD in 214 patients with treatment-resistant epilepsy across multiple epilepsy syndromes. Median reduction in monthly seizures was 36.5%. Established safety and preliminary efficacy across a broad range of epilepsy types.
DOI: 10.1016/S1474-4422(15)00379-8