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FDA Approves Epidiolex for Rare Epilepsy Forms
FDA news release: 2018 Jun 25
The US Food and Drug Administration (FDA) recently approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with 2 rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients ≥2 years. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome. The FDA granted approval of Epidiolex to GW Research Ltd., which has operations in both the US and the UK.
CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC).
Dosage/administration: Serum transaminases (ALT and AST) and total bilirubin levels should be obtained in all patients prior to starting treatment. Epidiolex is to be administered orally. The recommended starting dosage is 2.5 mg/kg taken twice daily (5 mg/kg/day). After 1 week, the dosage can be increased to a maintenance dosage of 5 mg/kg twice daily (10 mg/kg/day). Based on individual clinical response and tolerability, Epidiolex can be increased up to a maximum recommended maintenance dosage of 10 mg/kg twice daily (20 mg/kg/day).
Adverse reactions: The most common adverse reactions (≥10% for Epidiolex and > than placebo) are somnolence; decreased appetite; diarrhea; transaminase elevations; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder, and poor quality sleep; and infections.
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. FDA Web site. June 25, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm?utm_campaign=06252018_PR_FDA%20approves%20marijuana-derived%20drug%20to%20treat%20two%20forms%20of%20epilepsy&utm_medium=email&utm_source=Eloqua. Accessed June 26, 2018.