FDA Approval for First Marijuana-derived Drug

FDA Approval for First Marijuana-derived Drug

By Pharma Tech Outlook | Thursday, October 18, 2018

Marking a significant medical milestone, the U.S. Food and Drug Administration (FDA) has approved Epidiolex as the first marijuana-derived or cannabidiol-based drug for the treatment of pediatric seizure disorders such as Dravet syndrome and Lennox-Gastaut syndrome (LGS).

The symptoms of these pediatric seizure disorders include multiple seizures per day, developmental problems, and high risk for early mortality. These disorders are resistant to existing treatments and parents have even resorted to using marijuana oil (not guaranteed safe) for their children afflicted with these syndromes. While several states in the U.S. have legalized the use (medical and recreational) of marijuana, the high potential for abuse and no recognized medical application of the substance has impeded the legalization of marijuana.

In 2014, GW Pharmaceuticals, a UK-based company specializing in cannabinoid-based medicines, conducted research on the drug in more than 500 children and adults with treatment-resistant seizure disorders, battling the legal obstacles that have discouraged research into cannabis. The study results were assessed in April 2018 by an FDA advisory committee of experts from around the country, comprising a representative from NIDA’s Division of Therapeutics and Medical Consequences. The committee voted unanimously to recommend the approval of Epidiolex, given its effectiveness in reducing the frequency of seizures (compared to a placebo) with only mild or infrequent side effects.

The marijuana plant consists of the two primary compounds of cannabidiol (CBD) and tetrahydrocannabinol (THC), and Epidiolex has CBD as an active ingredient due to its anti-seizure properties. CBD does not cause the intoxication or the "high" that results from THC. Separating the psychoactive effects of THC from its potentially therapeutic properties, for instance, its antiemetic (anti-nausea) and analgesic (pain-fighting) properties, challenge the creation of safe medications that target the body’s endocannabinoid system (modulates functioning of brain, endocrine, and immune tissues).

Unlike the FDA approved drugs of dronabinol and banilone (antiemetics and appetite boosters) that use synthetic versions of THC, Epidiolex is made from the purified extract of the marijuana plant. The approval and use of this drug can genuinely prove revolutionary for seizure disorder treatment and redefine people's outlook towards the marijuana plant.

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