Epidiolex, the first FDA-approved drug derived from cannabis, could be available in as little as six weeks after being reclassified by the Drug Enforcement Administration as a Schedule 5 controlled substance. All other non FDA-approved products derived from cannabis remain illegal under federal law.
Schedule 5 controlled substances include codeine-containing cough medicines and are considered to have the lowest potential for abuse and have a proven medical use. Epidiolex contains a purified form of cannabidiol—also known as CBD—found in marijuana plants, and is indicated to treat two rare forms of treatment-resistant epilepsy in patients aged two and up.
The DEA rescheduling of Epidiolex was necessary before GW Pharmaceuticals could begin selling the oral solution since the DEA’s current classification of marijuana as a Schedule 1 drug defines it as both having a high potential for abuse and having no approved medical use. Schedule 1 classified drugs are considered illegal.
The FDA approved Epidiolex in June for the treatment of Dravet Syndrome and Lennox-Gastaut Syndrome, both rare forms of drug-resistant epilepsy that first present in childhood. Epidiolex is the first treatment option available to Dravet syndrome patients.
Only FDA-approved CBD-derived medications containing no more than 0.1 percent of tetrahydrocannabinol (THC), the psychoactive cannabis component responsible for getting people high, are covered under this new DEA rescheduling. Popular CBD-derived products like oils and lotions are still technically illegal under federal law. State by state, it’s a different story, with some having legalized both CBD and marijuana products.
“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. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D, in a statement announcing Epidiolex’s approval. “Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.”
In the same statement, Gottlieb emphasized the FDA’s commitment to continuing to support “rigorous scientific research” on other potential marijuana-derived products. The end result, Gottlieb said, is to provide patients with high-quality products that are safe and effective. He also cautioned that the FDA is prepared to take action against illegal CBD marketing touting unproven medical claims.
“Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases,” said Gottlieb.
GW Pharmaceuticals plans to have Epidiolex, which will be available by prescription only, within the next six weeks.