FDA Approves the Cannabis Based Drug Epidiolex to Treat TSC Seizures

As published by the Food and Drug Administration; The U.S. FDA has just approved the first FDA approved therapy derived from cannabis (Epidiolex, a CBD solution) to treat tuberous sclerosis complex (TSC) patients for their symptomatic seizures.  The drug will be available for patients a year or older, and will become the second available treatment option for the TSC triggered seizures.

Tuberous Sclerosis Complex (TSC)

Tuberous sclerosis complex (TSC) is a rare disorder in which patients experience benign tumor growths in the brain, organs, skin, or more. These growths cause a range of symptoms that differ from patient to patient, but often include seizures along with cognitive disabilities and behavioral issues. The hereditary disease varies widely in severity from patient to patient.

A Cannabis Based Treatment

While in the past the use of cannabis has been controversial, the medical world has been increasingly finding new ways to use CBD, a non-psychoactive ingredient in cannabis. In a press release by the FDA,  Dr. Douglas Throckmorton, deputy center director at the FDA’s Center for Drug Evaluation and Research regulatory programs, 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.”

Epidiolex Proves Effective

The study measured how Epidiolex affected the frequency that patients experienced seizures compared to a control group. The drug passed through a randomized, double-blind study that tested 224 patients over 16 weeks. The evidence proved Epidiolex to be extremely effective at reducing the rates of seizures.
While the treatment has proven effective at curbing seizures, it has side effects that are common with treatments for seizures. This includes fever, diarrhea, tiredness, vomiting, liver injury, weight loss, anemia, depression, or suicidal thoughts.

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