The U.S. Food and Drug Administration (FDA) gave its final approval to GW Pharmaceuticals‘ Epidiolex medication on Monday, completing a lengthy trial and review process.
Epidiolex is an oral CBD-based medicine for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, two conditions that begin in infancy and childhood and are characterized by varying and difficult-to-control seizures.
“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,” said FDA Commissioner Scott Gottlieb in a statement. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process is the most appropriate way to bring marijuana-derived treatments to patients.”
In clinical trials, Epidiolex proved to be effective in reducing the frequency of seizures in many patients with Dravet syndrome or Lennox-Gastaut syndrome.
According to the FDA press release, the most common Epidiolex-related side-effects were sleepiness, sedation, lethargy, elevated liver enzymes, appetite changes, diarrhea, rash, fatigue, malaise, weakness, insomnia, sleep disorder, poor-quality sleep, and infections. Side-effects were mild in most cases.
While cannabidiol (CBD) is still considered a Schedule I substance, the FDA determined in their review that its potential for abuse is negligible, and the FDA advises the DEA on controlled substance issues.
“The FDA Prepares and transmits, through the U.S. Department of Health and Human Services, a medical and scientific analysis of substances subject to scheduling, like CBD,” stated the FDA in their press release. “And provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the CSA.”
“DEA is required to make a scheduling determination.”
The FDA approval of Epidiolex is a turning point for cannabinoid-based medicine in the United States. A scheduling change for CBD could potentially open the door for the approval of other cannabis-based medication in the future and help facilitate expanded marijuana-focused research.