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

The Texas Department of Public Safety will be responsible for the licensing of at least three dispensing organizations by Sept. 1, 2017 before CBD will be available for patients.

CBD is the non-euphoric component of marijuana and contains no psychoactive properties, so it doesn’t produce a “high.” CBD is not administered by children smoking. It is typically formulated into an oil-based liquid so it can be given by mouth.

Texas agencies will regulate the distribution of the oils to patients whose symptoms have not responded to available treatments and the risks of treatment are outweighed by the potential benefits, according to their epileptologist. The treatment has to be agreed upon by two epileptologists before CBD can be administered.

M. Scott Perry, M.D., medical director of the Epilepsy Monitoring Unit and Tuberous Sclerosis Complex Clinic at Cook Children’s, estimates he discusses with parents and patients the pros and cons of marijuana use for epilepsy three or four times a day at minimum.

Dr. Perry said families are looking for any therapy that works for their child’s uncontrolled seizures once other options have failed, and some have either left the state or had plans on leaving Texas if the bill didn’t become law.

“I think we have seen enough in the other states that have already made CBD available to understand there is potential benefit to CBD use,” Dr. Perry said. “From what we’ve seen in the medical community so far, it’s very encouraging, but more research still needs to be done before CBD is a treatment of choice for most patients with epilepsy. For now, CBD may provide benefit for a small population with intractable (unmanageable) epilepsy, in which other treatments have been unhelpful. I’m glad that this bill will now afford me the same opportunity as other physicians in my field to prescribe CBD to this population of patients in Texas.”