Epidiolex would also be the first approved therapy for DS, treatments for which are now limited to a combination of seizure medication and drugs to prevent emergencies.
Two months after a unanimous recommendation by an outside group of FDA experts and some glowing recommendations in the internal review, GW will now set out to open up a new class of meds after demonstrating the drug's ability to prevent seizures in children suffering from rare cases of Lennox-Gastaut syndrome and Dravet syndrome. We are hopeful that the new GW drug will help many people with the two diseases it is approved for and for whom insurance will cover the drug.
Cannabidiol is structurally unrelated to other anti-seizure medications.
"It makes it harder for Congress to continue to list cannabis as a Schedule I controlled substance", Debra Borchardt, CEO at cannabis-focused financial media outlet Green Market Report, told Benzinga in April.
FDA officials noted the significance, signaling a new approach to looking at a plant still defined in federal law as having "no now accepted medical use". GW won't be able to market Epidiolex until the DEA reclassifies CBD.
Now with the approval of Epidiolex, a drug that will not produce an euphoric "high" feeling in the user - Devinsky said he expected CBD would be moved down to a schedule 4 or 5 drug, which is one that poses a low potential for abuse and dependence.
The DEA did not immediately respond to Ars' request for comment.
The FDA's decision is historic but it is not unexpected. With the approval, Epidiolex is expected to be available on US markets by September and become a $1 billion-plus seller. In three clinical trials covering 516 patients with either form of epilepsy, Epidiolex plus other antiepileptic medications reduced the frequency of seizures.
Still, this approval comes as the White House is said to be reconsidering federal prohibition of marijuana and as more and more states approve it for recreational and medicinal use. It is indeed a pressing issue for the CBD industry, as there is a large variation in the quality and efficacy of CBD products in the marketplace. A bill was introduced to the House past year to legalize the use of marijuana, but it has yet to reach the floor for vote.
"This is clearly a breakthrough drug for an bad disease", John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.