CBD-Based Epilepsy Drug Approved For Clinical Trials

CBD-Based Epilepsy Drug Approved For Clinical Trials

FDA Approves Studies For Marijuana-Based Epidiolex

The US Federal Drug Association approved clinical studies that aim to determine whether purified cannabidiol (CBD) is a viable anti-seizure treatment. Physician investigators will be provided with Epidiolex, a new 98% CBD product made by GW Pharmaceuticals, and conduct Investigational New Drug studies involving epileptic children.

According to O’Shaughnessy, the clinical studies will be sponsored by Orrin Devinsky, MD, at the NYU School of Medicine, and Roberta Cilio, MD, PhD, at University of California, San Francisco. Both are expected to monitor the progress of 25 patients, but they may enroll more with approval from the FDA. Additionally, Cilio will conduct two individual studies as well.

“GW Pharmaceuticals will provide researchers with their latest “pure CBD” product – Epidiolex.”

GW Pharmaceuticals, the British company responsible for the cannabis-based spray Sativex, will provide researchers with their latest “pure CBD” product – Epidiolex. The drug will come in the form of a viscous liquid to be dispensed in syringe droppers. Additionally, there will be two strengths available: 25 milligrams per milliliter and 100 mg/ml.

According to GW, Epidiolex contains no tetrahydrocannabinol (THC), the psychotropic component in cannabis. It is said to contain more than 98% cannabidiol (CBD) and trace amounts of other cannabinoids. GW chairman Geoffrey Guy, MD, told O’Shaughnessy, “Our definition of pure is no THC.”

Guy believes the studies will help provide “better understanding and experience in what cannabidiol does in these different children groups, what benefit we can see, and how the results can best be measured.”

Considering anecdotal evidence that cannabis can help treat epileptic seizures, and nearly 5 years of pre-clinical trial data from GW Pharmaceuticals, Guy expects more studies to come in the future.

“In the coming months, if the FDA is comfortable about how things are going, there will be a number of senior epileptologists in major university centers throughout the U.S., each treating a couple of dozen patients with various epilepsies,” he explained.

The contact information for the head researcher of each study is listed below:

Orrin Devinsky, MD – Director of NYU Comprehensive Epilepsy Center
223 East 34th Street 
New York, NY 10016 
Phone: (646) 558-0803 
 (646) 385-7164

Roberta Cilio, MD, PhD – UCSF Neurology Department
505 Parnassus Ave, Moffitt
San Francisco CA 94143
Fax: 415-502-5821

Loading Comments... ([[ count ]]) Comments
Leave a reply...

There are currently no comments for this topic. Be the first to leave a comment!

  • Want to stay in the loop?

    Join over 30,000 e-mail subscribers!

    By clicking submit I agree to the Privacy Policy

    Top cannabinoids

    Free Join the MJ Directory

    Welcome to the free database of cannabis companies, people, and events that anyone can add to. Ready to join the movement?

    Additional Reading View more
    An Overview Of Amyotrophic Lateral Sclerosis (ALS) Studies With Medical Marijuana
    An Overview Of ALS Studies With Medical Marijuana
    Over the last 10 years, multiple studies have shown whole-plant cannabis medicine may be a safe and useful therapy option for patients with ALS.
    Study Shows Tetrahydrocannabinol (THC) May Help Relieve Depression Symptoms
    Study Shows THC May Help To Relieve Depression Symptoms
    A dutch study published recently indicate that tetrahydrocannabinol (THC) administration may reduce the negative bias in emotional processing.
    A Guide to Making Marijuana Infused Tea
    A Guide to Making Marijuana Infused Tea
    For numerous patients, drinking this easily-prepared therapeutic tea offers a convenient and potentially healthier alternative to consuming cannabis.
    Study: Cannabidiol (CBD) May Help Fight Cognitive Impairments From Alzheimer’s
    CBD May Treat Cognitive Impairments from Alzheimer's
    A study published in Psychopharmacology has shown that cannabidiol (CBD) may be an effective treatment for cognitive impairments caused by alzheimer's

    Join thousands of other cannabis patients. Create an account Welcome back, [[ user.name ]]! Access your Dashboard

    Your browser is out-of-date!

    Update your browser to view this website correctly. Update my browser now