FDA-approved Epidiolex can now be prescribed in the U.S.
Following approval by the Food & Drug Administration (FDA) this past June, the first cannabis-based drug for treating epilepsy is now officially available. The drug, which was created by GW Pharmaceuticals, went on sale as of yesterday and is approved for patients two years old or older who suffer from Dravet syndrome or Lennox-Gastaut syndrome.
The introduction of a drug that is approved by a federally-backed organization in the U.S. should prove vital to further acceptance, both socially and legally. The FDA’s Dr. Scott Gottlieb pointed out that the drug was approved after only being submitted to stringent regulatory oversight. He explained, “Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery.”
GW Pharmaceuticals CEO Justin Gover explained that the two syndromes targeted by Epidiolex approval were designated specifically due to their resistance to other treatments. He said, “Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures.”
GW conducted a number of tests and clinical trials to ensure the legitimacy of Epidiolex in fighting the epilepsy symptoms. The results were staggering, with a drop of up to 42% in seizures among a study of 225 patients. Even better, only seven dropped out because of side effects. Dr. Orrin Devinsky, who led the study for GW, stated, “Compared to other drugs used to treat epilepsy, I think Epidiolex, which is 99-percent pure cannabidiol, has a better side-effect profile than many of the available drugs.”
The results of the studies were published this past May in the online version of the New England Journal of Medicine.