Epidiolex can now be prescribed by doctors in all 50 states. The DOJ and DEA classified the synthetic marijuana drug as a Schedule V substance. Three trials were conducted for the drug to gain approval.
The medication is approved for epileptics ages 2 and older, according to CNN. The side effects are minimal and include diarrhea, elevated liver enzymes, decreased appetite and sleepiness.
FDA Commissioner Dr. Scott Gottlieb said, via written statement, “The FDA will continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and stand ready to work with product developers who are interested in bringing patients safe and effective, high quality products.”
Pharmacist Shauna Garris believes that Epidiolex works well but remains skeptical for the drug to live up to its expectations. She acknowledged that gaining FDA approval of a marijuana-derived drug is a big deal that provides “validation of the science of cannabinoid medication.”
Dr. Orrin Devinsky led two of three clinical trial phases. He said, “In those syndromes, when [Epidiolex] was added to three other seizure [medications], on average, it reduced convulsive seizures — or ‘drop seizures’ — by about 25% to 28% compared to a placebo.”
GW Pharmaceuticals expects most insurance companies to cover Epidiolex. It estimates that the average list price of the drug will be about $32,500 annually. The company claims that the pricing is similar to “other branded, FDA-approved anti-epileptic drugs.”