Epidiolex, a new drug to treat seizures is the first-ever FDA approved cannabis-based drug.

Imagine being a parent with a child who has hundreds of uncontrollable seizures each week. This is the heartbreaking fate of people who suffer from two rare forms of epilepsy — Dravet syndrome and Lennox-Gastaut syndrome (LGS). Both disorders appear at a very early age, and both include “drop” seizures. Children with these disorders experience a much higher mortality rate, developmental issues and intellectual disabilities. The disorders are incredibly rare: about 6,000 Americans have Dravet, while around 30,000 suffer from LGS.

Unfortunately, both disorders are typically not responsive to standard epilepsy drugs. But as of June 25, these patients have new hope. Why? Because the U.S. Food and Drug Administration (FDA) just approved a drug called Epidiolex, the first natural cannabis-based drug created to treat both forms of epilepsy.

Epidiolex, America’s First Cannabis-Based Drug

GW Pharmaceuticals tremendous body of research, including its clinical trial of over 500 epilepsy patients (both children and adults), helped the FDA in its decision. Results of the clinical trial were published in the New England Journal of Medicine and showed that Epidiolex when used alongside conventional anti-seizure medications, reduced seizures by more than 40 percent.

GW treated many children free of charge through its compassionate access program. The company hopes to have the medication available in the U.S. by the fall, and says it has enough medication to treat all 36,000 Americans who suffer from Dravet and LGS.

GW’s first launch of cannabis-based medicine was a product called Sativex, a sublingual spray for treating the spasticity that often accompanies multiple sclerosis (MS). Sativex became the first cannabis-based medicine licensed in the UK, and after its success, GW began work on a cannabis-based seizure treatment. Early in the product’s development stages, the parents of 11-year-old Sam Vogelstein approached GW, desperate for a cure for Sam’s severe epilepsy. Under the compassionate use program, the boy was given a purified cannabis oil product, the precursor to Epidiolex. It worked, and Sam has been free of the debilitating seizures for more than two years, and happily testified to the FDA to tell of the drug’s success.

Epidiolex’s main active ingredient is a substance called cannabidiol, or CBD, one of over 100 active compounds called cannabinoids that researchers have isolated from the Cannabis sativa plant. GW Pharmaceuticals specifically breeds its plants to have very high CBD concentrations for medical purposes, then uses the extracted CBD to create Epidiolex, a pharmaceutical-grade CBD oil. CBD has no hallucinogenic effect, unlike THC, the well-known cannabinoid known for producing the characteristic marijuana “high.”

The Legal Status of Cannabis

In the U.S. thus far, 20 states have approved some form of medical cannabis use, and nine states like California and Colorado, as well as the District of Columbia, have legalized cannabis for recreational use. However, the drug remains illegal at the federal level, classified as a Schedule 1 drug under the Drug Enforcement Agency’s (DEA) Controlled Substances Act (CSA). The Schedule 1 classification deems the drug of high risk and no medical benefit. Cannabis is classified alongside other Schedule 1 drugs like heroin and LSD, and is more regulated than either opium or cocaine.

The Schedule 1 status greatly restricts research that can be performed on medical benefits of cannabis. In fact, research is limited to studying the addictive behavior of cannabis or the negative impacts of the drug.

It seems that more and more federal influencers are changing their minds. Last year, a government-commissioned group of experts concluded that the U.S. is creating a risk to public health by not engaging in more research about CBD’s potential medical benefits. Certainly, this week’s FDA approval of Epidiolex marks a major milestone as well.

Now that the FDA has approved Epidiolex, the DEA must formally reclassify CBD into a different category other than Schedule 1, because the drug now has federal medical approval. The reclassification must occur before the product can be sold in the U.S.

GW expects that will occur, and expects to soon have the drug on U.S. pharmacy shelves, ready for doctors to prescribe. While GW Pharmaceuticals has not yet set a price for the drug, Wall Street analysts have estimated that the drug may cost as much as $25,000 per year.

Epidiolex is poised to be GW Pharmaceuticals’ blockbuster drug, and since doctors have the leverage to prescribe the drug for other uses, the company will perhaps experience annual sales that could exceed $1 billion in the U.S. alone.

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