Expert panel recommends CBD medication for use in 2 epilepsies

Dr. Jose Cavazos of UT Health San Antonio serves on FDA advisory committee.

Dr. Jose Cavazos
Jose E. Cavazos, M.D., Ph.D., UT Health San Antonio

A U.S. Food and Drug Administration advisory committee on April 19 recommended approval of the first cannabidiol (CBD) medicine for prescription use in two severe pediatric epilepsy syndromes. The vote was 13-0.

Jose E. Cavazos, M.D., Ph.D., professor of neurology and physiology at UT Health San Antonio and assistant dean of the institution’s M.D./Ph.D. program, was invited to review clinical studies of the drug, which would be sold under the brand name Epidiolex.

“I was asked to evaluate the scientific credibility of the evidence—whether there was sufficient research data—to recommend approval of this drug to treat Lennox-Gastaut and Dravet syndromes, which are two types of catastrophic epilepsy,” Dr. Cavazos said.

Children with these syndromes experience many seizures a day and treatment choices are extremely limited.

CBD is plant’s non-addictive component

CBD is derived from the Cannabis sativa plant, famous as the source of marijuana. CBD is a non-addictive component of the plant, in contrast to tetrahydrocannabinol (THC), which is a component that produces the high of marijuana and is addictive.

Epidiolex is a proprietary oral solution of plant-derived CBD that contains little (less than 0.1 percent) THC, and it does not give the euphoric or abuse potential effects of THC. Clinical trials indicate the medication can decrease the frequency of “drop attacks” and other symptoms of Lennox-Gastaut. In these attacks, a person suddenly stiffens and falls with the head facing forward. Children with Lennox-Gastaut may wear helmets to prevent head injuries.

Controlled CBD use has been legal in Texas since 2015 when lawmakers passed the Texas Compassionate Use Act. Earlier this year, CBD oil dispensaries were created, allowing families of children with epilepsy to obtain the oil with physician authorization. “The pharmaceutical-grade CBD is being dosed at a much higher dose (between 10 and 100-fold) than the most common dose of the CBD oil sold in Texas dispensaries,” Dr. Cavazos said.

Potential for rescheduling

Cannabidiol products are classified as Schedule 1 substances under the U.S. Controlled Substances Act. Schedule I substances are defined as drugs with no currently accepted medical use and a high potential for abuse. Dr. Cavazos indicated that the scientific data showed little or no potential of abuse for CBD in the double-blinded clinical trials presented to the FDA review panel.

Linda Leary, M.D., clinical associate professor of neurology and pediatrics in the Joe R. & Teresa Lozano Long School of Medicine at UT Health San Antonio, said FDA final approval, when granted, should result in the drug being rescheduled for use in the two childhood syndromes of catastrophic epilepsy.

Helping families when guidelines don’t exist

Some Texas institutions, including UT Health San Antonio, are assisting families who want to try CBD in their children with difficult-to-control epilepsy, Dr. Leary said.

“One reason we are willing to do this is that at least we can help families to use it safely,” Dr. Leary said. “CBD is not viewed as a miracle, but is one more medication that could work to control seizures.”

The FDA decision is significant because it will affect insurance status and provide safety guidelines and dosing instructions, Dr. Leary said. No guidelines currently exist for use of the Texas dispensary products, leaving families and physicians little information.

Footnotes

—Dr. Cavazos served on the FDA Peripheral and Central Nervous System Drugs Advisory Committee.

Andrea Giuffrida, Ph.D., professor of pharmacology and vice president for research at UT Health San Antonio, has studied the pharmacology of the cannabinoid system for 21 years, although not CBD specifically, he said.

Charles France, Ph.D., professor of pharmacology and the Robert A. Welch Distinguished University Chair in Chemistry, said cannabinoids are a key component of his team’s research program and are part of an active National Institutes of Health grant.

The University of Texas Health Science Center at San Antonio, now called UT Health San Antonio, is one of the country’s leading health sciences universities. With missions of teaching, research, healing and community engagement, its schools of medicine, nursing, dentistry, health professions and graduate biomedical sciences have produced more than 33,000 alumni who are leading change, advancing their fields and renewing hope for patients and their families throughout South Texas and the world. To learn about the many ways “We make lives better®,” visit www.uthscsa.edu.



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