Medical marijuana is available in about half of the states.
Epidiolex is created to treat two rare forms of childhood epilepsy. What's more, the DEA will reportedly reschedule CBD in light of the FDA's decision, greatly loosening restrictions on research. The drug contains cannabidiol, or CBD, and does not make users high while reducing the rate of seizures in patients with Dravet or Lennox-Gastaut syndromes, clinical trials show. It is the fourth marijuana-based medicine to receive US FDA approval - joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros). Rescheduling cannabidiol paves the way for other advanced cannabinoid formulations, like the ones now being researched and developed by scientists on staff at my Colorado-based cannabinoid science business, ebbu. She is cautiously optimistic about FDA approval of Epidiolex, the first drug made of CBD.
The drug contains nearly non of the psychoactive chemical from marijuana that makes people high and proved through testing to be effective in treatment of certain pediatric seizure patients.
That's because these kids did not experience as many side effects from the cannabidiol, which can include tiredness, decreased appetite, diarrhea and signs of possible liver damage, Devinsky explained. "However, we remain concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims".
Marijuana now has an accepted medical use. Similar results were reported in a Phase 3 placebo-controlled trial among 171 patients with Lennox-Gastaut syndrome published this year in the Lancet. "This new treatment provides new options for patients".
And Epidiolex's approval doesn't mean other CBD substances are OK to sell, Gottlieb said. Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy.
While this move will undoubtedly increase profits for GW Pharmaceuticals, predicting annual sales eventually reaching $1 billion, it could also bring some much-needed relief to hundreds of thousands of children afflicted with more complex variations of epilepsy for which traditional treatments have been mostly ineffective.
A reclassification is expected within 90 days, according GW Pharmaceuticals.
With the historic approval, the London-based company behind the drug, GW Pharmaceuticals plc, is expecting another consequential decision in the coming weeks: getting the US Drug Enforcement Administration to reclassify CBD. The actual list price of Epidiolex has not been set, but has been estimated at $2,500 to $5,000 a month, significantly more expensive than other CBD-based medication made available through state-legal medical cannabis programs.
The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education.