FDA Makes First Approval of Medication Containing Cannabis Substance CBD

Cannabidiol, aka CBD, is having a bit of a moment. The marijuana-derived compound has been lauded over the past few months for its many reported health benefits, and recently, the Food and Drug Administration officially approved a medication containing CBD, making it the first cannabis-based drug available across the country.

Yesterday, June 25th, the FDA issued a press release stating that it had approved the seizure medication Epidiolex for the mass market. Epidiolex is an orally administered medicine that uses CBD to treat two extremely rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. The release noted that this is the “first FDA-approved drug that contains a purified drug substance derived from marijuana.”

Justin Gover, the CEO of GW Pharmaceuticals, which manufactures Epidiolex, told CNN that the drug will be available starting in the fall. He did not specify how much the twice-daily medication will cost, saying that GW Pharmaceuticals has to consult with insurance companies to determine the price.

As HuffPost reported, the use of Epidiolex in clinical trials led to 39% fewer seizures in patients with Dravet syndrome and 37% fewer seizures in patients with Lennox-Gastaut syndrome.

FDA’s approval of a CBD drug product demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies, including those to address unmet medical needs. https://t.co/QpqLYS0gyYpic.twitter.com/qPt7gR2cqj

— U.S. FDA (@US_FDA) June 25, 2018

Philip Gattone, president and CEO of the Epilepsy Foundation, told GW Pharmaceuticals that the medication was a “true medical advancement.”

"Clinical development for these rare and severe conditions is essential, and today’s news brings hope for these patients and their families that a new treatment option may have the potential to help better control their seizures," Gattone told the company.

[email protected]_FDA announced today the approval of Epidiolex (cannabidiol) oral solution for the treatment of seizures for Lennox-Gastaut syndrome & Dravet syndrome for children 2 yrs of age or older. Read our statement on this medical advancement: https://t.co/XzXqyZvNge

— Epilepsy Foundation (@EpilepsyFdn) June 25, 2018

Although several states have already legalized medical marijuana, the FDA’s authorization of Epidiolex could open doors for the legalization of CBD nationwide. The Drug Enforcement Administration (DEA) currently classifies all forms of marijuana as Schedule I substances, meaning even medical use is illegal federally. But Barbara Carreno, the DEA’s press officer told marijuana publication Leafly that FDA approval could cause CBD’s re-classification.

"The FDA is the entity in America that approves medicines. Not DEA, we’re cops. We depend on them to tell us if something’s a medicine," Carreno told Leafly earlier in June. "If they on June 27 announce that they’re approving Epidiolex, absolutely we’ll go into a different schedule. There’s no ifs, ands, or buts about it."

Of course, unapproved uses of CBD are still illegal, and the FDA has said that it will continue to penalize these uses. But yesterday’s announcement is a small step toward legalizing medical marijuana, and we’re excited for the medical advancements to come.