A strawberry-flavored oral solution containing cannabidiol (CBD) derived from cannabis plants is one step closer to being approved by the U.S. Food & Drug Administration for treating two rare forms of epilepsy in children. The drug would be the first of its kind to enter the U.S. market, opening the door to a new era of cannabis-derived medicines.
FDA scientists concluded in a report released on April 17 that the drug, Epidiolex, produced by GW Pharmaceuticals and its U.S. subsidiary Greenwich Biosciences, is safe and effective. A panel of outside experts agreed, voting unanimously in favor of the drug’s approval on April 19.
Epidiolex contains CBD extracted from cannabis plants bred to contain high levels of the compound. The solution does not contain the primary psychoactive compound in cannabis, ∆9-tetrahydrocannabinol (THC), which is responsible for the euphoria and high associated with cannabis products.
FDA previously authorized GW Pharmaceuticals to distribute Epidiolex as an investigational drug to help control seizures in more than 1,100 children with rare, treatment-resistant forms of epilepsy. FDA’s approval of the drug would expand access to Epidiolex for patients with two forms of the disease and possibly for patients with other disorders through off-label prescriptions.
FDA approval would also put more pressure on the Drug Enforcement Administration to reclassify CBD under the Controlled Substances Act. All cannabis-derived compounds are currently considered schedule I controlled substances, meaning they have no accepted medical use.
“This favorable outcome marks an important milestone in our company’s unwavering commitment to address the significant unmet need for patients with Lennox-Gastaut syndrome and Dravet syndrome and our resolve to study Epidiolex under the highest research and manufacturing standards,” GW’s Chief Executive Officer Justin Gover said in a statement.
FDA is expected to decide in June whether to approve Epidiolex.