Home » FDA Grants Priority Review to Cannabidiol-Derived Seizure Drug
FDA Grants Priority Review to Cannabidiol-Derived Seizure Drug
Drugs Submissions and Approvals
The FDA granted priority review to GW Research’s cannabidiol oral solution Epidiolex.
The product is indicated for treatment of seizures associated with Dravet Syndrome or Lennox-Gastaut Syndrome. Cannabidiol is derived from marijuana but does not produce the high caused by THC.
The FDA based the move on a series of well-controlled clinical trials and Commissioner Scott Gottlieb said the agency remains committed to its gold standard for product development and review, to ensure that “any new therapies from marijuana and its constituents are safe, effective and manufactured to a high and consistent quality.