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FDA approves the nation’s first cannabis-based medicine


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The Food and Drug Administration has finally approved a cannabis medication.

On Monday, the FDA approved the GW Pharmaceuticals’ Epidiolex to treat two rare forms of epilepsy. The medication is an oil primarily made of CBD an does not produce a “high” for its users. In clinical trials, Epidiolex was shown to reduce seizures by 40 percent in patients with Dravet or Lennox-Gastaut syndromes. Previously, there had not been a medication approved to treat Dravet syndrome.

“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 said in a statement. “And, the FDA is committed to this kind of careful scientific research and drug development.”

The approval comes as no surprise, though, as FDA officials had previously supported Epidiolex and an advisory panel unanimously recommended its approval.

“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”

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