Cannabidiol-Based Epilepsy Drug Studied at Cook Children’s Approved By FDA
The FDA has approved the first cannabinoid-based treatment for rare, severe forms of epilepsy.
Greenwich Biosciences (GW Pharma) received the approval for Epidiolex, an oil-based purified cannabidiol (CBD), studied specifically in two rare epilepsy syndromes - Lennox Gastaut and Dravet Syndrome.
Cook Children’s participated in several of GW Pharmaceutical’s clinical trials of Epidiolex used to treat children over the age of 2 with Lennox Gastaut and Dravet and continues to enroll children in a trial of the drug for treatment of seizures in Tuberous Sclerosis Syndrome.
The trials were the largest of their kind in the world and have provided the gold-standard evidence needed to prove cannabidiol can be effective as a treatment for epilepsy,” said M. Scott Perry MD, Medical Director of Neurology and principle investigator for the trials performed at Cook Children’s.
The Drug Enforcement Agency (DEA) now has 90 days to schedule epidiolex and it is expected to be available to the public by fall 2018.
Dr. Perry said with the FDA’s approval there now is a standardized, reliable, safe and effective form of CBD oil available for people with epilepsy.
“It means the door is opening for more treatments from the cannabis plant, not just for epilepsy,” Dr. Perry said. “The company (GW Pharma) has shown how quality research, using cannabis can be done safely, scientifically and legally to achieve a result that will prove beneficial to many.”
Dr. Perry explains that Epidiolex is an essentially pure CBD substance produced under strict standards to ensure the drug is the same with every batch. With its approval, the drug will be obtained from a pharmacy, prescribed by a doctor and more likely to be covered by insurance.
Scott Gottlieb, M.D., Commissioner of Food and Drugs, said the FDA will continue to support rigorous scientific research on the potential medical uses of “marijuana-derived product and work with product developers who are in interested in bringing patients safe and effective, high quality products.”
"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” Dr. Gottlieb said.
Previous Articles On This Topic:
- 9 Facts about Cannabidiol (CBD) Oild and The Texas Compassionate Use Act
- Texas legalizes non-euphoric cannabdiol for seizures in epileptic patients
- Success in CBD study: Cook Children's researchers play a vital role
- Cannabis oil trial ongoing at Cook Children's
- Study: Cannabis Oil Can Dramatically Decrease Epileptic Seizures
Get to know M. Scott Perry, M.D.
I joined the Neurosciences Program of Cook Children's in 2009 as a pediatric epileptologist, then served as the Medical Director of the Epilepsy Monitoring Unit and Tuberous Sclerosis Complex clinic before assuming the role of Medical Director of Neurology in 2016. My clinical and research interests focus on the treatment of childhood onset epilepsy, specifically those patients with uncontrolled epilepsy or those for which the cause has not been determined. I have an intense interest in the use of surgical therapies to treat and cure epilepsy. The majority of my research has investigated the use of multimodal imaging techniques to localize seizure onset, as well as the description of patient and disease characteristics that predict favorable outcomes from surgical therapies. The pool of candidates which may benefit from surgical therapy continues to expand and I came to Cook Children's specifically because the staff of the Epilepsy Monitoring Unit and Comprehensive Epilepsy Program were dedicated to improving the care of children with epilepsy through cutting-edge techniques, research, and concern for their patients' well-being. Click to learn more.