FDA Panel Gives Thumbs Up to CBD-Based Epilepsy Medication
[dropcap class=”kp-dropcap”]A[/dropcap] United States Food and Drug Administration (FDA) panel unanimously recommended a cannabis-derived drug for epilepsy, paving the way for the first plant-based cannabinoid drug approved for epilepsy.
Epidiolex is an oral cannabidiol-based drug produced by British company GW Pharmaceuticals. If approved by the FDA, it will join several other approved synthetic cannabinoid drugs like Cesamet, Syndrox and Marinol. Synthetic versions of cannabis chemical compounds are often used to alleviate nausea in cancer patients, simulate appetite in people living with AIDS and ease neuropathic pain and spasticity in multiple sclerosis patients.
The FDA panel recommends Epidiolex to treat two rare forms of epilepsy, Lennon-Gastaut syndrome and Dravet syndrome. Patents dealing with these forms have difficulty controlling seizures with currently available medications. These syndromes appear between age three and five and the large number of seizures associated with the life-risking conditions put children at risk for intellectual and developmental disabilities. The FDA could approve the drug as early as June 27.
“This is a very good development, and it basically underscores that there are medicinal properties to some of the cannabinoids,” Dr. Igor Grant, director of the Center for Medical Cannabis Research at the University of California San Diego, told The New York Times. “I think there could well be other cannabinoids that are of therapeutic use, but there is just not enough research on them to say.”
GW Pharmaceuticals also got a positive review from FDA clinicians for Epilodex. “I think it’s fair to say that this product, it stands apart from the rest of our portfolio,” said GW Pharmaceuticals CEO Justin Gover to The Cannabist. “It is by far the most important product that we are developing today.” GW also produces Sativex, the first cannabis-based prescription drug approved in the world which is accepted in several European countries and Canada.
GW Pharmaceuticals has not released pricing information for Epilodex yet, but analysts are estimating patients could pay $30,000 or more if insurance doesn’t cover the costs. However, the FDA-approval helps determine that would be covered, unlike current cannabis-based CBD oils and medical cannabis which is not FDA approved.
