FDA panel backs proposed epilepsy drug derived from cannabis

An FDA advisory panel on Thursday unanimously recommended approval of a prescription cannabidiol medication for the treatment of rare forms of epilepsy. With a vote of 13-0, the panel said the risk-benefit profile was favorable for cannabidiol (EpidiolexGW Pharmaceuticals) to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 2 years and older. According to the drug’s manufacturer, the medicine is made from a proprietary strain of cannabis that maximizes a therapeutic component while minimizing components that produce euphoria. Company-sponsored clinical trials found that cannabidiol reduced the frequency of patients’ seizures. One study of 120 children and young adults with Dravet syndrome found that cannabidiol lowered the median frequency of convulsive seizures from 12.4 a month before treatment to 5.9 a month, while patients who received a placebo saw only minimal decreases. While the drug is associated with some adverse eventssuch as gastrointestinal problems and abnormal liver-function

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