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FDA approves first plant-derived cannabinoid (CBD) drug

Epidiolex (cannabidiol) is the first medication based on a purified drug substance, cannabidiol (CBD), derived from marijuana to gain approval from the US Food and Drug Administration (FDA).

The drug is indicated for patients aged two years and older with Lennox-Gastaut syndrome or Dravet syndrome, two uncommon but severe forms of epilepsy. The drug is also the first medication approved by the FDA for treating Dravet syndrome, a rare, lifelong genetic dysfunction of the brain that causes seizures and usually first manifests in infants.

“In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition,” said Billy Dunn, MD, director of the Division of Neurology Products at the FDA’s Center for Drug Evaluation and Research. 

Epidiolex is an oral solution containing CBD, a chemical component of the marijuana plant. The component should not be confused with tetrahydrocannabinol (THC), which is the primary psychoactive component of marijuana. It is the THC in cannabis that leads to intoxication and the euphoric “high” associated with the drug. 

Around half the states in the US have legalized medical marijuana, which is used for pain management, seizure disorders, and several other conditions. Among these are muscle spasms from multiple sclerosis, nausea caused by chemotherapy, poor appetite or weight loss related to chronic illnesses (such as HIV), and Crohn’s disease. 

The FDA has already approved man-made forms of THC, such as Cesamet (nabilone) or Marinol (dronabinol) for the treatment of nausea and to improve appetite. However, Epidiolex is the first plant-derived cannabinoid prescription medication to gain FDA approval. 

Commenting on the latest approval, the FDA’s Commissioner Scott Gottlieb, MD, said important medical therapies could be developed with further sound development programs to properly evaluate the active ingredients of marijuana. He highlighted the importance of controlled clinical trials to test safety and efficacy of drugs, asserting that this is the “most appropriate way to bring marijuana-derived treatments to patients”. 

Approval of Epidiolex was granted following three randomized, double-blind, placebo-controlled clinical trials involving more than 500 patients with Lennox-Gastaut syndrome or Dravet syndrome. The trials demonstrated the efficacy of the drug in reducing the frequency of seizures compared to those patient given a placebo.

Side Effects of Epidiolex

Common side effects experienced in the trial included: sleepiness; lethargy; elevated liver enzymes; a decrease in appetite; diarrhea; rash; fatigue; insomnia; poor quality sleep; and infections. 

Other risks associated with all epilepsy medications include suicidal thoughts and actions; feelings of agitation; and new or worsening depression, panic attacks or aggression. The medication was also found to cause liver injury, and while this was generally mild, there is the possibility it could lead to more severe liver injury. 

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