Monday, June 25, 2018
Formal FDA approval for Epidiolex means some part of the federal government finds some part of cannabis plant has "accepted medical use"
This new CNN piece, headlined "FDA approves first cannabis-based drug," reports on the big news from the federal government concerning a very specific form of medical marijuana. Here are the details:
The US Food and Drug Administration approved a cannabis-based drug for the first time, the agency said Monday. Epidiolex was recommended for approval by an advisory committee in April, and the agency had until this week to make a decision.
The twice-daily oral solution is approved for use in patients 2 and older to treat two types of epileptic syndromes: Dravet syndrome, a rare genetic dysfunction of the brain that begins in the first year of life, and Lennox-Gastaut syndrome, a form of epilepsy with multiple types of seizures that begin in early childhood, usually between 3 and 5.
"This is an important medical advance," FDA Commissioner Dr. Scott Gottlieb said in a statement Monday. "Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery."
The drug is the "first pharmaceutical formulation of highly-purified, plant-based cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs," according to a statement Monday from GW Pharmaceuticals, the UK-based biopharmaceutical company that makes Epidiolex....
The FDA has approved synthetic versions of some cannabinoid chemicals found in the marijuana plant for other purposes, including cancer pain relief. Justin Gover, chief executive officer of GW Pharmaceuticals, described the approval in the statement as "a historic milestone." He added that the drug offers families "the first and only FDA-approved cannabidiol medicine to treat two severe, childhood-onset epilepsies."
"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," Gover said. Epidiolex will become available in the fall, Gover told CNN. He would not give any information on cost, saying only that it will be discussed with insurance companies and announced later....
It's an option for those patients who have not responded to other treatments to control seizures. According to the Epilepsy Foundation, up to one-third of Americans who have epilepsy have found no therapies that will control their seizures. Shauna Garris, a pharmacist, pharmacy clinical specialist and adjunct assistant professor at the University of North Carolina's Eshelman School of Pharmacy, said the drug is effective and works somewhere between "fairly" and "very well." She has not used Epidiolex in her own clinical practice and was not involved in the development of the drug but said she's not sure it will live up to "all of the hype" that has surrounded it....
As part of the FDA's review of the medication, the potential for abuse was assessed and found to be low to negative, according to Gover. 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. Gover said the approval signals "validation of the science of cannabinoid medication."
As the title of this post highlights, this news serves as still further proof of the misguided placement of marijuana as a Schedule I drug under the Controlled Substances Act defined as having "no currently accepted medical use in treatment in the United States." But, it should also be realize that this news serves as proof that the federal government, even without any reform to the CSA, can and will approve a cannabis-based medicine which has been "thoroughly studied in clinical trials [and] manufactured to assure quality and consistency." Thus, the catch-22 comes from the fact that marijuana's placement on Schedule I precludes US-based companies from doing the types of clinical trials that the FDA demands. (If we had a well-functioning federal government, marijuana surely would have been at least re-scheduled to Schedule II or III under the CSA many years ago. But I digress....)