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FDA Approves CBD Medicine, Signals Enforcement Priorities Against Unapproved Products

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FDA on Monday announced approval of a cannabidiol (CBD)-based drug derived from marijuana, and its top official signaled where the agency will focus its enforcement priorities against companies marketing unapproved CBD products.

Epidiolex, the medicine developed by GW Pharmaceuticals plc, was approved by FDA to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients at least two years old. Many parents who have children suffering from certain forms of epilepsy have turned to CBD, but the federal government has largely considered CBD a Schedule I controlled substance, or marijuana derivative, with no acceptable medical use—until now.

Justin Gover, GW’s chief executive officer, described FDA approval of Epidiolex as “a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies.”

“This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine,” he said in a press release. “These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

During a conference call with reporters, Douglas Throckmorton, M.D, an FDA official, confirmed the Drug Enforcement Administration (DEA) will need to reschedule CBD into one of the schedules other than Schedule I under the Controlled Substances Act. Barbara Carreno, an DEA spokeswoman, did not immediately respond to a request for comment on the process and timing for such action, though Throckmorton said FDA wanted to get Epidiolex available to patients “as quickly as we possibly can.”

“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,” FDA Commissioner Scott Gottlieb, M.D., said in a news release. “And, the FDA is committed to this kind of careful scientific research and drug development. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients.”

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