FDA approves first cannabis-based drug for rare forms of epilepsy

FDA’s approval of a cannabidiol (CBD) medicine to treat seizures associated with two severe forms of epilepsy is a positive sign for other CBD drugs under development.

After accepting the New Drug Application for GW Pharmaceutical’s Epidiolex in January, FDA officially approved the drug on June 25. It is the first FDA-approved drug that contains a purified drug substance derived from marijuana, FDA said in a statement.

Epidiolex treats seizures in patients ages 2 years and older with rare forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

Related: Cannabis-derived epilepsy drug on the horizon

“This is the first time the FDA has approved a product based on naturally-extracted cannabinoid. This signifies a tectonic shift in the agency’s policy, keeping in mind that any derivative from the cannabis plant are scheduled in Schedule 1 of the CSA by the DEA,” George Anastassov, CEO of AXIM Biotechnologies, a manufacturer of cannabinoid pharmaceuticals, told FormularyWatch.

The approval of Epidiolex should stimulate the efforts of AXIM, along with other CBD pharma makers, including Insys Therapeutics, Zynerba, and Therapix, “to bring to market drugs based on naturally-extracted cannabinoids,” Anastassov added.

As a result of the Epidiolex approval, clinical research efforts should be expanded and possibly accelerated, Dr. Stuart Titus, CEO of Medical Marijuana, Inc.,  the first publicly traded cannabis company in the US, told FormularyWatch, “especially given the potential reception by the medical community, who have shown significant interest in new and novel treatments for neurological disorders.”

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“Many doctors are excited to have an additional medication to potentially assist those who have been failed by conventional treatment protocols,” Titus added.

Meanwhile, FDA is committed to “this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, MD, in a statement from the agency. “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.”

However, Gottlieb warned that the agency is “prepared to take action when we see the illegal marketing of CBD-containing products with serious, 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.”

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