Cannabis-Based Seizure Medicine on Track for FDA Approval This Year

If the FDA approves Epidiolex, which is derived from purified cannabidiol, the federal agency will be confirming that a cannabinoid does indeed have an official medical use.

by Chris Moore 

A cannabis-derived medication may become widely available across the U.S. later this year after a promising new study has confirmed the drug's ability to effectively reduce seizures. Epidiolex, a drug comprised of purified cannabidiol, was created by GW Pharmaceuticals in order to treat a wide variety of seizure disorders. This week, a research study published in the Lancet journal confirmed the efficacy of the drug, increasing the chances that the FDA will approve the medication for use in the U.S.

The new study investigated the effects of Epidiolex on patients with Lennox-Gastaut syndrome who were suffering seizures that could not be controlled by existing pharmaceuticals. According to GW Pharmaceuticals, this is “the only well-controlled clinical evaluation of a cannabinoid medication for this severe, drug-resistant condition.”

The research team randomly divided 171 patients aged between 2 and 55 into two groups, one of which received Epidiolex, while the other received a placebo. Over the 14-week study period, 44% of the patients taking the CBD-based drug saw a significant reduction in seizures.

"For some, it does not do a whole lot," Elizabeth Thiele, director of pediatric epilepsy at Massachusetts General Hospital and lead author of the study, told The Washington Post. "But for the people it does work in, it is priceless."

The results of the Lancet study dovetail nicely with another study published last year in the New England Journal of Medicine, which found that Epidiolex was able to effectively and safely treat symptoms of Dravet syndrome, another severe form of epilepsy. Although the FDA has not fully approved the use of Epidiolex, around 1,500 Americans are currently taking the drug under the agency's "compassionate use" exemption, which allows some products to be used on a limited basis before they receive the FDA's final approval.

Normally, the FDA would have no issues with approving a drug that has demonstrated such promising clinical results, but the fact that Epidiolex is derived from a federally-prohibited drug has been making things difficult for GW Pharmaceuticals. In addition to following the strict rules imposed by the FDA for all new drug trials, the company must also ensure that all hospitals where the drug is being tested are inspected and licensed by the DEA.

Cannabis, in all its consumable forms, is currently classified by the feds as a Schedule I narcotic, which is reserved for dangerous drugs with no medical use. If the FDA approves Epidiolex, the agency will be confirming that a cannabinoid does indeed have an official medical use, and Epidiolex will have to be placed into a different schedule. Unfortunately, this potential rescheduling will not apply to cannabis in general, or even to other CBD-based medicines. That said, having the federal government officially admit that a form of cannabis has medicinal benefits would be another promising sign for the future of medical marijuana usage throughout the U.S.