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 (Epidiolex—GW 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 is designed to maximize 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 events—such as gastrointestinal problems and abnormal liver-function test results—FDA officials said Thursday they thought the risks were manageable if cautionary language is included on the drug's prescribing label, and if FDA monitors liver risk after the drug is put on the market. Agency officials also noted the drug does not appear to have abuse potential. FDA is expected to decide by the end of June whether to approve the drug for sale.
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