A 16-year-old Californian with debilitating epilepsy for 10 years joined a study for a new drug containing cannabidiol or CBD, the non-hallucinatory chemical found in marijuana plants. That teen, Sam Vogelstein, reported having up to 100 seizures a day at one time. Two-and-a-half years after taking the new drug, Epidiolex, he hasn’t had a single seizure.
Sam’s dad Fred Vogelstein wrote for Wired that “the manufacturer, GW Pharmaceuticals, knew little about epilepsy back then. But Sam’s response was so extraordinary, their executives decided they needed to learn more about the disease, and quickly embarked on clinical trials. Sam actually tried the medicine in London under a doctor’s supervision. Such a trial in the UK was straightforward, whereas conducting it in the U.S. would have been impossible because of our cannabis laws. Since then nearly 1,800 patients have tried it at U.S. hospitals, with about 40 to 50 percent seeing greater than 50 percent reductions in seizures. That sounds small until you consider that admission to the trials required patients to have exhausted all other medicinal options. Officially, Epidiolex will be approved only to treat two of the most severe types of epilepsy, Dravet and Lennox Gastaut syndromes. But doctors will likely have the flexibility to prescribe it for other epilepsies too. Many epilepsy drugs are prescribed this way, known as off label. (Many patients, including Sam, are on more than one drug.)
A Food and Drug Administration panel of scientists and doctors voted 13-0 to recommend approval. The FDA is expected to render a final decision on the drug by June. According to Fred, if the drug is fully approved, it could change the lives of 3 million people suffering from epilepsy in the U.S., and 73 million worldwide.
You can read more about the process and its potential here.
