Posted by Michael Wonder on 01 Aug 2020
FDA approves new indication for drug containing an active ingredient derived from cannabis to treat seizures in rare genetic disease
31 July 2020 - Today, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with tuberous sclerosis complex in patients one year of age and older.
Epidiolex was previously approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. This is the only FDA approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with tuberous sclerosis complex.
Epidiolex’s effectiveness for the treatment of seizures associated with tuberous sclerosis complex was established in a randomised, double-blind, placebo-controlled trial where 148 patients out of a total of 224 in the study received Epidiolex.
