U.S. health officials announced on April 17, 2019 that a medicine made from the marijuana plant is effective at reducing seizures in children with various forms of severe epilepsy. They also called for FDA approval to move forward in the United States for this purpose. The medicine known as Epidiolex would have limited availability, but it remains an important step forward in the treatment of disorders like epilepsy.
The British company GW Pharmaceuticals is the manufacturer of the drug; if the recommendation of health officials is followed by the Food and Drug Administration, this syrup would be the very first drug derived from cannabis to win federal approval for use in the United States.
Fewer Seizures without Getting High or Hooked
Three separate studies were done showing that the medication significantly reduces seizures in children who suffer from two rare forms of epilepsy. The 13 members of the FDA panel voted unanimously in favor of the experimental medication, which does not get users high. Panel member Dr. John Mendelson of the Friends Research Institute in Baltimore, Maryland explains, “This is clearly a breakthrough drug for an awful disease.”
Possible Side Effects of Medical Marijuana for Epilepsy
There are risks to taking the medication, as is the case with most medicines. The drug has the potential to cause liver damage; however, patients can be monitored for any signs of such. There are other side effects slightly more common as well, which include sleep problems, fatigue, vomiting, and diarrhea.
Epidiolex approval would be limited to use exclusively by patients with forms of epilepsy that are traditionally difficult to manage and resistant to many contemporary treatments. However, doctors would still have the option to prescribe it for other uses as well down the road, spurring new research and interest for other marijuana-based products, treatments, and medications in the near future.
What Exactly is Epidiolex?
Epidiolex is a pharmaceutical-grade version of CBD oil, which some people have used for many years to treat children who suffer from epilepsy. CBD is just one of more than 100 chemicals found in cannabis; it contains no HTC, which is the ingredient that is responsible for the mind-altering effects of street marijuana. CBD oil is currently available online and in shops in several states and is made from hemp. Hemp is a form of cannabis with very little THC that is legally farmed in many states for food, clothing, and other uses.
The goal of GW Pharmaceuticals was made clear in a statement by company executive Steve Schultz: “We’re not looking to impact the availability of other products on the market. Our goal is to provide an additional option for patients and physicians who desire a purified version of CBD for treatment of seizures,” he explained. While the company states their goal is a research-backed, more standardized version of CBD, they also declined to comment on the price of the drug, which Wall Street analysts approximate could be $25,000 per year.
Although more than two dozen states currently allow medical marijuana use for many different ailments, the FDA still has not yet approved the ingredient for any medical use. There have been synthetic versions of a different cannabis chemical approved by the FDA for other medical uses, however. Hope is on the horizon for many pediatric sufferers of epilepsy that is otherwise difficult to treat; the final decision on the drug is expected by the end of June 2019.