A little ahead of schedule, the Food and Drug Administration approved GW Pharmaceutical’s CBD-based medication for epilepsy. It is designed as an oral medication to treat two specific types of epilepsy in children above two. The medicine will still need to be prescribed by a physician versus being available for purchase in dispensaries.
Despite CBD’s growing popularity in the US, the medicine had some struggles to see approval as this one is derived from cannabis instead of hemp. This means that the plant’s THC levels were higher than the federal guidelines of .3%, thus categorizing it as cannabis. Hemp itself has tiptoed legality for some time but, most derived products are not seen as any issue considering its low psycoctive levels. Epidiolex, the FDA-approved medicine, has made history by being a federally approved cannabis-derived product.
“Today’s approval of EPIDIOLEX is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies. This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.” — Justin Gover, GW Pharmaceuticals Chief Executive Officer, in a press release
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.” — FDA Commissioner Scott Gottlieb, in a press release
Though cannabis is still a schedule 1 substance based on the Controlled Substances Act, CBD has long been debated for its medicinal use. After all, the approval comes towards Epidiolex, not cannabis as a whole. The DEA is, however, expected to reschedule CBD within the next 90 days with the news.
Written by: Joycelin Arnold
