FDA Recommends Approval of First Marijuana-Based Drug

On Thursday, a Food and Drug Administration (FDA) advisory council recommended approval for an epilepsy drug that would be the first plant-derived cannabidiol medicine for prescription use in the US.

The drug, Epidiolex, was developed to treat severe, early onset epilepsy syndromes. The chemical derived from the marijuana plant, cannabidiol, in contrast to tetrahydrocannabinol (THC), does not produce a high to the user.

FDA approval would limit the drug’s use to patients who have epilepsy, though doctors would have the option to prescribe the drug off-label for other uses.

GW Pharmaceuticals, the maker of Epidiolex, said two experimental trials showed significant reductions in seizure types compared to patients taking placebos.

​The FDA is set to vote for the drug’s approval in June.