Reported by Q13 Fox, an advisory committee to the U.S. Food & Drug Administration (FDA) has unanimously recommended that the FDA approve a CBD-based medication for the treatment of epilepsy. Epidiolex, an orally-administered CBD-based medication, is scheduled to visit before the FDA for a vote on whether to release it to a small group of patients struggling with severe epilepsy.
The committee’s unanimous vote of approval happened after reviewing data submitted from medication’s developer, U.K.-based biopharmaceutical company GW Pharmaceuticals PLC. The product was specifically developed for three severe forms of epilepsy, including Dravet Syndrome, which begins in the first year of life, Lennox-Gastaut Syndrome, which presents with multiple kinds of seizures, and tuberous sclerosis complex, which presents in infancy. While FDA approval would be specific to prescriptions for these conditions, doctors would have latitude to prescribe the product for “off label” applications.
As Indicating By Shauna Garris, a pharmacist, pharmacy clinical specialist and adjunct assistant professor at the University of North Carolina’s Eshelman School of Pharmacy, adverse effects including negative drug interactions are of concern:
“There have been side effects associated with it, and it appears a lot of the side effects were in conjunction with other medications, which is a concern, because most of those patients are on other medications… that’s not uncommon for antiepileptic medications. Most of our antiepileptic medications have terrible side effects and interact with each other.”
In a statement from GW Pharmaceuticals, the company explained that in separate clinical trials, Epidiolex effected, “significantly greater reductions” in certain kinds of seizures for those administered the product compared with those who were not.