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 
Fax:
 (646) 385-7164

Roberta Cilio, MD, PhD – UCSF Neurology Department
505 Parnassus Ave, Moffitt
San Francisco CA 94143
Phone415-514-8415
Fax: 415-502-5821
Emailmaria.cilio@ucsf.edu

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

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
    Study: Cannabichromene (CBC) May Aid In Brain Development
    CBC In Medical Marijuana And Its Effects On The Brain
    Study: Cannabichromene (CBC) Found In Cannabis May Aid Medical Marijuana Patients In Furthering Brain Development
    Terpenes: What Are Terpenoids And What Do They Do?
    Terpenes in Cannabis: What Are Terpenoids In Marijuana?
    Learn about terpenes, terpenoids, and their synergistic effects with medical marijuana and different cannabinoids found in the cannabis plant.
    Study Shows THC In Cannabis May Help Delay Retinal Degeneration, Vision Loss
    THC May Slow Vision Loss From Retinitis Pigmentosa
    A Spanish study has shown that a synthetic form of tetrahydrocannabinol (THC) may be used to inhibit vision loss caused by retinitis pigmentosa.
    A Look Into Mental Health and Medical Marijuana
    Mental Illness & Marijuana: Cause or Cure?
    Past reports have indicated the medical marijuana may cause mental illnesses while in fact research has shown that it may help treat them.

    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

    ×