The Federal Drug Administration is poised to make history should it approve a new drug for treating epilepsy called Epidiolex. What makes this oral solution unique is its active ingredient – cannabis. This shouldn’t come as a surprise to Missouri residents as the state has already recognized the value of medical marijuana in helping patients with intractable epilepsy. But that’s currently the only condition for which the state allows medicinal cannabis treatments.
The Missouri Patient Care Act seeks to bring a reasonable, regulated medical cannabis industry to the voters on the 2018 ballot. This petition requires certification from a licensed physician prior to receiving treatment but goes beyond epilepsy to include any other qualifying conditions. Today, physicians are willing to recommend brain surgeries to their epileptic patients even though success ranges from 20% to 90%, but for those with intractable epilepsy, surgery is not effective.
Now, a FDA-approved panel of 13 experts has unanimously agreed that Epidiolex is both safe and effective. The main ingredient, cannabidiol (CBD), does not contain THC, known to provide the “high” associated with smoking marijuana. In two large clinical trials, the new drug improved conditions significantly. The first study of 225 patients with Lennox-Gastaut Syndrome saw a 42% reduction in seizure occurrence. The second trial was comprised of 120 children with Dravet syndrome. Convulsive seizures were cut in half among 43% of those taking the drug with 5% achieving complete freedom from seizures.
To date, no antiepileptic drug has been approved in the United States for patients with Dravet syndrome. As exciting as this news is to parents, patients and physicians, this preliminary approval by the expert panel does not guarantee that the FDA will officially approve the drug when they convene on June 27. To do so would require the Drug Enforcement Administration to remove cannabis from their list of Schedule 1 drugs. To date, the DEA holds fast to their belief that marijuana (cannabis) has no currently accepted medical use.