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FDA Approved Cannabis-Based Drug

Kayli Mak, Staff Writer

Epidiolex is the first cannabis-based drug to be approved by the Food and Drug Administration (FDA). It is now available in the entire U.S. Epidiolex and is used to treat two different varieties of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome.

Dravet and Lennox-Gastaut syndrome both often manifest severely in early childhood. Dravet syndrome is rare, and the brain dysfunction typically appears within the first year of life. On the other hand, Lennox-Gastaut syndrome is a form of epilepsy that encompasses several different kinds of seizures, and it typically appears between the first three and five years of life.

The drug was produced to treat these two conditions by GW Pharmaceuticals. CEO Justin Gover said, “Because [patients with these syndromes] have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures.” Cannabis has certainly been a controversial topic in the media and in politics, with the plant only becoming legalized for use in certain states in very recent years. However, the medical promise of marijuana has been far less disputed.

After being approved, Epidiolex was classified as a Schedule V substance, despite its parent substance, cannabidiol (CBD), which remains as a Schedule I substance. Schedule I substances have no currently accepted medical uses and have a high potential for abuse. On the other hand, Schedule V has a lower potential for abuse and are readily available by prescription.

Epidiolex contains highly purified, plant-derived CBD, which does not cause the delirium typically associated with marijuana. The American Epilepsy Society has supported the FDA-approved drug, stating that while it does contain cannabis, it is not the same as medical marijuana, which contains tetrahydrocannabinol (THC) and thus causes that “high”.

As for its effects, the drug has been shown to reduce convulsive seizures by about 25% to 28% when compared to a placebo. Some common side effects of Epidiolex include sleepiness, diarrhea, decreased appetite, and an increase in liver enzymes. It is estimated to cost approximately $32,500 per year, which is similar to the cost of other antiepileptic drugs currently approved by the FDA. Even though it is targeted toward Dravet syndrome and Lennox-Gastaut syndrome, doctors are allowed to prescribe it “off-label” for other similar conditions.

In spite of its measure effectiveness, pharmacist Shauna Garris stated that the approval of the cannabis-based drug “signals validation of the science of cannabinoid medication.”

Photo courtesy of NBCNEWS.COM

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FDA Approved Cannabis-Based Drug