FDA Approves Marijuana-Based Epilepsy Drug

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The U.S. Food and Drug Administration (FDA) has approved the first medication containing a purified substance derived from marijuana to treat rare, severe forms of epilepsy. This medicine, called Epidiolex (cannabidiol [CBD]) oral solution is approved to treat Lennox-Gastaut and Dravet syndromes in adults and children over age 2. It’s the first drug approved by the FDA for the treatment of Dravet syndrome.

The component of marijuana used in Epidiolex – cannabidiol – doesn’t induce feelings of euphoria, or “high,” typically associated with cannabis, which is caused by a chemical in marijuana called tetrahydrocannabinol (THC).

Lennox-Gastaut syndrome and Dravet syndrome – conditions that both begin in childhood – cause frequent seizures and severely impact patients’ quality of life. In three randomized, double-blind, placebo-controlled clinical trials involving 516 patients, Epidiolex, with other medications, effectively reduced seizure frequency. Common side effects include sleepiness, elevated liver enzymes, decreased appetite, diarrhea, rash, and weakness.

Sourced from: FDA