Washington, D.C. – A Food and Drug Administration advisory panel yesterday unanimously recommended approval of an epilepsy medication made with CBD oil.
If the agency follows the recommendation, as is expected, the drug would be the first pharmaceutical formulation of purified, plant-based CBD, a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs (AEDs).
The drug, called Epidiolex, is made by GW Pharmaceuticals, a British company that develops cannabinoid-based medicines. Epidiolex is designed for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients two years of age and older, according to a company press release.
LGS and Dravet syndrome, which develop in childhood, are devastating forms of epilepsy with high morbidity and mortality rates and a significant burden on families and caregivers. More than 90% of patients with LGS or Dravet syndrome have multiple seizures per day, which puts them at constant risk for falls and injury. Physicians who treat LGS and Dravet syndrome patients struggle to reduce the sheer volume of dangerous seizures with currently available therapies. If approved, Epidiolex would be the first-ever FDA-approved medicine for Dravet syndrome patients.
“We are pleased by the Advisory Committee’s unanimous recommendation to approve Epidiolex, which would provide an important treatment option for patients with LGS and Dravet syndrome, two of the most severe and treatment-resistant forms of epilepsy,” said Justin Gover, GW’s chief executive officer. “This favorable outcome marks an important milestone in our company’s unwavering commitment to address the significant unmet need for patients with LGS and Dravet syndrome and our resolve to study Epidiolex under the highest research and manufacturing standards. We look forward to our ongoing discussions with the FDA as it continues to review the Epidiolex NDA.”
There are already several drugs on the market that are derived from synthetic versions of THC and other chemicals of the cannabis plant, generally used to ease nausea in cancer patients, and to help AIDS patients avoid weight loss, according to a report from The New York Times.
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