August 07, 2020

FDA Approves Epidiolex for Treatment of Seizures Caused by Rare Genetic Disease

The FDA announced on July 31 that it had approved Epidiolex (cannabidiol or CBD) oral solution for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age and older.  Epidiolex had previously been approved by the FDA for the treatment of seizures in patients 2 years of age and older diagnosed with Lennox-Gastaut syndrome and Dravet syndrome, two serious and rare forms of epilepsy.  Epidiolex, a marijuana-derived drug, is the first and only FDA-approved prescription CBD treatment.  The DEA had originally placed Epidiolex in schedule V of the Controlled Substances Act.  However, in April 2020, the DEA announced that it would be descheduling Epidiolex, and many states have announced that they have or will follow suit.