Cannabidiol, or CBD, is one of over eighty active compounds found in cannabis. Unlike some other compounds like tetrahydrocannabinol (THC), CBD does not produce a mind altering effect in individuals, and studies have shown it can improve the symptoms of patients suffering from a range of medical conditions. The FDA has already approved its use for some medical purposes, including cancer and pain relief.
For some time, patients suffering from some types of epilepsy have been calling for it to be approved to manage their symptoms. According to the Epilepsy Foundation, one in three Americans suffering from epilepsy have yet to find an effective treatment to control their seizures. This affects an estimated one million families in the US.
However, a new drug called Epidiolex is now a step closer to being approved by the FDA. The drug, which is delivered to patients orally, is intended to treat certain types of severe epilepsy in a small group of patients. An FDA advisory committee has already unanimously recommended that the drug should be approved and available to prescription in the US The agency is due to vote on the matter in June this year.
The company that produces Epiliolex is GW Pharmaceuticals PLC. It’s one of their leading products for treating severe, early onset forms of epilepsy, including Dravet syndrome, Lennox-Gastaut syndrome and tuberous sclerosis complex and infantile spasms.
CEO Justin Gover commented: “We’re obviously very pleased by the unanimous recommendation in support of the approval of Epidiolex. It’s a very important milestone in the approval process. It’s a breakthrough in the field of epilepsy. It’s the first cannabis-based pharmaceutical to be approved by the FDA. It’s the first in a new class of treatments with a new mechanism of action against epilepsy.”
According to Shauna Garris, pharmacist and clinical specialist at the University of North Carolina’s Eshelman School of Pharmacy, those in the industry would be very surprised if the new drug failed to obtain approval by the FDA. She said “there’s so much publicity and so much hype” surrounding the product, adding that in trials it’s shown to work between “fairly” and “very well” in managing symptoms.
She added: There have been side effects associated with it, and it appears a lot of the side effects were in conjunction with other medications, which is a concern, because most of those patients are on other medications,” however, “that’s not uncommon for antiepileptic medications. Most of our antiepileptic medications have terrible side effects and interact with each other.”