FDA Approves First Cannabis Based Drug
Epidiolex was recommended for approval back in April by an advisory committee and this week, the FDA has finally approved the first cannabis based drug.
This is an important medical advance," FDA Commissioner Dr. Scott Gottlieb said in a statement on 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."
Epidiolex is intended for use 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.
"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," said Justin Gover, chief executive officer of GW Pharmaceuticals. 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 GW Pharmaceuticals.
The drug does have side effects, but the most common one is sleepiness. Shauna Garris, a pharmacist, pharmacy clinical specialist and adjunct assistant professor at the University of North Carolina's Eshelman School of Pharmacy, clarified that many of the side effects occur when it is taken with other medications. Although combining Epidiolex with other drugs could risk experiencing side effects, Garris claims, "that's not uncommon for antiepileptic medications," because most antiepileptic patients are on other medications.
Epidiolex will become available in the fall, Justin Gover told CNN. He would not give any information on cost, saying only that it will be discussed with insurance companies and announced later.