FDA Approves First Drug Derived From Marijuana Plant (wsj.com)
The U.S. Food and Drug Administration on Monday approved the first prescription drug derived from the marijuana plant, as a treatment for rare forms of epilepsy that primarily afflict children. From a report: The FDA said Monday that it cleared GW Pharmaceuticals's Epidiolex, also known as cannabidiol, to reduce seizures associated with forms of epilepsy known as Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 years of age and older. Cannabidiol is derived from the cannabis plant, also known as marijuana. U.K.-based GW Pharmaceuticals says the solution, taken by mouth, is made from a proprietary strain of cannabis designed to maximize a therapeutic component while minimizing components that produce euphoria. GW Pharmaceuticals grows the plants in the U.K.
The FDA said Monday that the drug doesn't cause the high that comes from the chemical tetrahydrocannabinol, or THC, which is the main psychoactive component of marijuana. FDA officials also said the drug doesn't appear to have abuse potential, citing minimal reports of euphoria in patients who took the drug in clinical studies. Further reading: StatNews, The Guardian, and FDA.
The FDA said Monday that the drug doesn't cause the high that comes from the chemical tetrahydrocannabinol, or THC, which is the main psychoactive component of marijuana. FDA officials also said the drug doesn't appear to have abuse potential, citing minimal reports of euphoria in patients who took the drug in clinical studies. Further reading: StatNews, The Guardian, and FDA.
The active ingredient in this drug (cannabidiol, CBD) is still listed as a Schedule 1 controlled substance (Cannabis Extracts), and rescheduling it would be a public admission that the plant it is derived from also has medical applications, and itself would then be disqualified for Schedule 1 status.
Will be really interesting how the inter-agency pissing contest over this plays out, now that Big Pharma has some skin in the game...
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