FDA Approved CBD to Treat Tuberous Sclerosis Complex

The FDA-approved drug Epidiolex just received the FDA green-light to add the disease to its clinical indications.
Luca Marani
Written by Luca Marani, Cannabis Educator
Last Updated
FDA

As announced in a press release by GW Pharmaceuticals on July 31st, the U.S. Food and Drug Administration gave its approval for the company’s CBD-based drug Epidiolex to be used in the treatment of seizures associated with tuberous sclerosis complex (TSC), in patients that are at least 1 year old. Epidiolex was already approved for the treatment of seizures associated with two rare epileptic diseases, Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS).

What is tuberous sclerosis complex?

TSC is a rare (1 in 6000 people) genetic disease that triggers the growth of benign tumors in the brain and other parts of the body like the eyes, heart, kidneys, lungs, and skin. This disease usually imapairs the central nervous system, and this can bring along a plethora of symptoms including seizures, developmental delay, and behavioral problems. However, the disease’s symptomatology, as well as the its severity, can vary a lot.

Epidiolex’s efficacy as a treatment of the seizures associated with TSC was determined in a randomized, double-blind, placebo-controlled trial where 148 patients out of a total of 224 in the study received the drug. The study measured the change from baseline in seizure frequency. Participants treated with Epidiolex had a significant reduction in the frequency of seizures than those who were administered placebo.

Meeting the FDA’s standards

As the statement on the government agency’s website reads, “the FDA continues to believe the drug approval process represents the best way to make new medicines, including any drugs derived from cannabis, available to patients in need of appropriate medical therapy such as the treatment of seizures associated with these rare conditions. This paradigm ensures new therapies are safe, effective, and manufactured to a high quality that provides uniform and reliable dosing for patients.” These are the words of Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “The agency is committed to supporting rigorous scientific research on the potential medical uses of cannabis-derived products and working with product developers who are interested in bringing patients safe and effective, high quality products.”

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Luca Marani
Luca Marani
Cannabis Educator
Luca Marani is an educator and content creator from Italy. He graduated in 2017 from Universitat Pompeu Fabra in Barcelona, Spain, with a Master of Arts in Political Philosophy, writing a dissertation on what was the state of the medical cannabis legislative framework in Spain at the time, and how it affected the rights of the Spanish medical cannabis users community to dignity and quality of life.

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