A recent study published in the New England Journal of Medicine represents a watershed moment for recognizing the medical applications of CBD within the scientific community.
Funded by GW Pharmaceuticals, the rigorous double-blind placebo-controlled trial involved 120 children and young adults who suffer from a severe form of childhood epilepsy called Dravet syndrome. Within the study, those who received cannabidiol, or CBD, showed a dramatic reduction in the frequency of seizures. These results demonstrate a lynchpin moment in confirming the effectiveness of CBD and may prove to be just the push the FDA needs to approve the use of cannabis-based medication to treat epilepsy.
Orrin Devinsky, principal investigator and director of the Comprehensive Epilepsy Center at New York University Langone Medical Center, told Scientific American that the results of the report speak for themselves and underscore the importance of conducting further research into CBD treatments for epilepsy.
“This study clearly establishes cannabidiol as an effective anti-seizure drug for this disorder and this age group,” Devinsky said. “It certainly deserves to be studied in other types of epilepsy.”
The results of the study were released in May and showed that over the course of 14 weeks, those who received CBD experienced a median number of 5.9 seizures (down from 12.4) as opposed to those who received a placebo, who experienced 14.1 seizures in the month (down from 14.9). GW Pharmaceuticals is on the cusp of submitting its cannabinoid-based drug Epidiolex for FDA approval in the treatment of Dravet syndrome and Lennox–Gastaut syndrome, and the positive results of the recent study may further advance CBD science within the U.S.
Even before this report, the effectiveness of CBD for seizure disorders was not completely unknown. As early as 1980, Raphael Mechoulam — the Israeli biochemist credited with the isolation of both CBD and THC — released findings that revealed the effectiveness of CBD for epilepsy. Although Mechoulam’s research showed improvement in almost all patients who received cannabidiol, it wasn’t until 2013 — when neurologist Sanjay Gupta told the story of Charlotte Figi, a young girl suffering from Dravet syndrome whose symptoms greatly improved with the use of CBD — that the world really began to take notice. Gupta’s CNN special “Weed” highlighted Figi’s story and triggered a wave of states enacting laws that allowed for the use of CBD, which unlike THC, is nonpsychotropic and does not result in the feeling of being “high.”
CBD has shown a wide range of potential medicinal applications including acting as an antispasmodic, antiepiletpic and anti-inflammatory. The cannabinoid has also demonstrated neuroprotective qualities and has exhibited beneficial effects in bone formation and healing fractures. Despite such promising early findings, the DEA still classifies CBD as a Schedule I substance with “no currently accepted medical use,” which greatly hampers medical research on this cannabinoid.
GW Pharmaceuticals , which is based in the U.K., recently opened an office in California in anticipation of FDA approval for Epidiolex. On Sept. 13, the company’s CEO Justin Glover addressed shareholders at the Morgan Stanley Global Healthcare Conference and alluded to the development of additional cannabinoid-based medications.
“Of course, we continue to believe that cannabinoids are — there’s more than just CBD and more than just CBD in epilepsy,” Glover said. “So as a company, the company’s been — over the last 18 years has developed an important positioning as leaders in the world of cannabinoid science… there is an awful lot more within this area of science that GW already has data on and will continue to prosecute over the years ahead.”
GW has reported that it expects to submit Epidiolex for a new drug application (NDA) by the close of 2017. With more affirmative results like those found in the recent report, perhaps FDA approval of cannabinoid-based medication is now even closer than ever before.