FDA Approves Clinical Trials For Cannabis-based Epilepsy Drug

DISTRICT OF COLUMBIA: The U.S.  Food and Drug Administration has approved clinical trials of a cannabis-based drug and its effects on epilepsy.  The treatment, Epidiolex, is 98 percent purified cannabidiol ( CBD ) made by GW Pharmaceuticals based out of the U.K.

There are around 60 known chemicals contained in cannabis called cannabinoids.  Tetrahydrocannabinol, also known as THC, is the main component responsible for the drug’s psychoactive nature.  CBD, however, is the second most abundant cannabinoid in the cannabis and provides medicinal benefits without the “high.”

Epidiolex will come in a viscous liquid form to be dispensed from syringes.  A 25 milligram per meter or 100 milligram per meter will be the two strengths made available to those in the trials.

The FDA has approved of intermediate-sized clinical trials sponsored by two doctors.  Dr.  Orrin Devinsky, a professor in the Department of Neurology, Neuroscience and Psychiatry in the New York University School of Medicine and director of the NYU Comprehensive Epilepsy Center, and Dr.  Roberta Cilio, a pediatric neurologist at the University of California, San Francisco, are set to follow 25 patients using Epidiolex as treatment for pediatric epilepsy.

On Oct.  4, at the NYU Langone Medical Center, Devinsky led a conference entitled, “Cannabidiols: Potential Use in Epilepsy & Other Neurological Disorders.” During the affair, Devinsky and Cilio led a presentation on planned trials on CBD in children with treatment resistant epilepsy.

The D.C.  – based Marijuana Policy Project’s Communications Director Mason Tvert responded to the news of the approved trials.  “We’ve long known that marijuana has a variety of medical benefits,” Tvert said.  Tvert added that the federal government clearly recognizes marijuana’s medicinal benefits and it’s a shame they hindered most research of it.

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