FDA Approves Marijuana-Based Epidiolex Drug in Historic First

This weed extract won't get patients high, but it will help prevent seizures.

Flickr / Brett Levin Photography

Medical marijuana is already legal in 29 states, but on Monday, the Food and Drug Administration moved toward nationwide access for the health benefits associated with cannabis.

Once the weed derivative cannabidiol (CBD) is reclassified from a Schedule I drug, the medication Epidiolex can be prescribed to epilepsy patients across the country.

Epidiolex treats two types of rare and serious epilepsy, but it doesn’t get users high. CBD oil has been revered for its success in healthcare, and in clinical trials, it was shown to reduce the number of seizures in users with Dravet or Lennox-Gastaut syndrome by 40 percent. Prior to today’s announcement, support for the drug was expected, thanks to a unanimous recommendation from an advisory panel. The only notable risk is potential effects on the patient’s liver, but that can be monitored by a doctor when necessary.

Why the Drug Isn’t Legal

People with Dravet or Lennox-Gastaut syndrome experience up to dozens of seizures a day. One in five patients die before they turn 20. And until CBD oil is rescheduled by the Drug Enforcement Agency, which currently lists it as having no medical value and a high risk for abuse, there are no available medications for those with Dravet syndrome. There are six other drugs approved to treat Lennox-Gastaut syndrome. Signs of both appear in early childhood in the form of epileptic seizures.

Cannabis can be grown to be high in CBD and low in THC, the component that delivers a high. Synthetic forms of THC have been approved by the DEA as a schedule II or III drug, meaning they have medicinal purposes but still show the potential for abuse. But until naturally-occurring CBD is distributed federally, parents of children with Dravet and Lennox-Gastaut syndromes have moved to states with legal recreational weed to treat their kids on the sly — but companies selling legal pot still can’t market their product as medicinal in any way, or the FDA can interfere, which has been in the form of warning letters in the past.

How the Drug Works

Since CBD isn’t the psychoactive component of marijuana, it doesn’t target the part of the brain that results in getting blazed. Instead, in Epidiolex, an oral dosage of CBD targets the brain elsewhere to deliver relief to patients whose seizures result in a sudden inability to stand or control their own movement. And unlike other medications and treatments for seizures, Epidiolex doesn’t just stop seizures, but prevents them, especially in higher dosages. The other drugs on the market, called Dronabinol and Nabilone, are derived from synthetic weed, and are less effective.

Which States Have Legal Weed? The 2018 Guide for All 50 States

The strain of weed parents are buying for their epileptic kids in states like Colorado is called “Charlotte’s Web,” named after the favorite book of its first young patient who was successfully treated with it. The THC content is low enough that it doesn’t produce euphoria, but that doesn’t account for the way desperate families feel to finally find hope in a medication that can alleviate devastating side effects.

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