FDA approves CBD treatment for seizures associated with tuberous sclerosis complex

pharmafile | August 3, 2020 | News story | Sales and Marketing CBD, tsc 

The FDA has approved Epidiolex (cannabidiol) as a treatment for seizures associated with tuberous sclerosis complex (TSC) in patients over one.

This follows after a clinical trial containing 224 TSC patients, where 148 took the oral CBD treatment. The study showed a greater reduction in the frequency of seizures compared to those who took a placebo, with the effect being seen within eight weeks which remained consistent throughout the trial period of 16 weeks.

Douglas Throckmorton, Deputy Center Director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, commented on the approval and said: “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. 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.”

Some patients experienced side effects including decreased appetite, sleepiness, diarrhea, fever, vomiting and elevated liver enzymes. Some also experienced weight gain and increased creatinine.

TSC is a rare genetic disease that causes non-cancerous tumours to grow in the brain and other parts of the body, while it also affects the central nervous systems. It affects roughly one in 6,000 Americans.

Conor Kavanagh

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