On Monday, the FDA approved the cannabis-based drug, Epidiolex, for use. “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.”1
The drug was made by GW Pharmaceuticals, a UK-based biopharmaceutical company. (One wonders why GW Pharma is allowed to make something that’s illegal to use in the UK?)
Quite frankly, it’s about time. FDA Commissioner Dr. Scott Gottlieb said in a statement, “This is an important medical advance. 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.”2 (But did you know that growers have been successfully making CBD oil for these issues for years now? And they are organic and created in sterile, controlled environments.)
Justin Gover, chief executive officer of GW Pharmaceuticals, said that Epidiolex would be available in the fall but didn’t give any information on cost. According to the Epilepsy Foundation, up to one-third of Americans who have epilepsy have found no therapies that will control their seizures.3 The European Medical Society is also considering approval of Epidiolex and expects to announce a decision in the first quarter of 2019.
“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.
There are side effects, the most common being sleepiness, Gover said. But Garris highlighted that many of the side effects occur when it is taken with other medications, which she said is a concern because most patients are on other medications.
There are likely to be drug interactions, she said, but “that’s not uncommon for antiepileptic medications,” and she noted that this could affect the effectiveness of the medication.”4
Currently, “a phase three clinical trial is underway for a third seizure-related condition called tuberous sclerosis complex, which begins in infancy and causes a sudden stiffening of the body, arms and legs, with the head bent forward.”5 If the results are positive, the company will apply for supplemental approval for this condition. It’s also possible that Epidiolex could be prescribed for off-label use.
While it’s nice to finally have cannabinoid science validated, I’ll take CBD oil from anyone else but Big Pharma, any day.