The US Food and Drug Administration is one step closer to approving a prescription CBD oil. Participants in an Idaho case study may have played a role in the decision-making process.
A panel of federal advisers unanimously voted last week to recommend the approval of the Epidiolex, the first prescription cannabidiol medicine, to treat severe forms of epilepsy.
Epidiolex is a pharmaceutical brand of CBD oil, a cannabis derivative that lacks the psychoactive compound found in marijuana.
Forty Idaho children diagnosed with epilepsy have been part of the state’s Expanded Access Program. Children in the program are legally allowed to use Epidiolex under the care of a doctor. Their progress while using the drug is documented.
“That information is supplemental, given to the [FDA advisory] panel to take a look at for safety and tolerability of the drug,” Idaho Office of Drug Policy Administrator Nicole Fitzgerald said.
Consumers can find products claiming to contain CBD oil online. Some makers of those products have been issued warnings by the FDA for their unsubstantiated claims.
“When we look at making public policy, we felt like we have to make sure it’s science and not politics that creates medical approval,” Fitzgerald said.
An Idaho legislative panel killed a bill to legalize CBD oil in the state during the 2018 session.
The FDA has until June 27 to make a decision on the approval of the drug. The FDA has indicated they intend to approve Epidiolex.
“We do hope the FDA approves this and it will be something available by the end of the year,” Fitzgerald said.
The recommended use for Epidiolex is limited to specific, severe forms of epilepsy. If made legal, though, doctors may prescribe the product as they see fit.
Epidiolex is produced by British company GW Pharmaceuticals. The price of the drug has yet to be determined, but experts expect it to mirror the cost of other epilepsy medications already on the market.