FDA Committee Recommends Approval For GW Pharmaceuticals (GWPH) Cannabis-Derived Drug

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The larger implications for cannabis-based drugs are less clear, and researchers were measured about this opening the floodgates because of US restrictions on researching the compounds, as well as other illegal drugs that might have medical uses. Dronabinol, sold under the brand name Marinol, comes close, but is based on synthetic THC, and not cannabis plant-derived cannabinoids.

GW has gathered some impressive efficacy data on their drug, pitched to prevent seizures in children suffering from rare cases of Lennox-Gastaut syndrome and Dravet syndrome. The agency has indicated it would act by late June on the application from GW Pharmaceuticals, a British company that would market the drug. And, as Bloomberg, Reuters and other outlets reported, the drug seems to be working.

"It's an enormous milestone", Orrin Devinsky, who specializes in epilepsy at the New York University Langone Medical Center, said in an interview before the advisory panel meeting.

GW Pharmaceuticals offered "substantial evidence" to back Epidiolex's effectiveness, according to the FDA panel's report.

The timing is remarkable for a few reasons.

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Analysts had expected a positive advisory committee recommendation, and they also expect the drug to be prescribed off-label for other types of epilepsy if it is approved.

The Drug Enforcement Administration continues to classify marijuana as a Schedule I drug, meaning it has no proven medical value and a high risk of abuse.

Epidiolex is a plant-derived CBD extract, with some additives for flavor, that's taken orally in syrup form. It has less than 0.1 percent THC, and is now being considered to treat Dravet syndrome and Lennox-Gastaut syndrome, two very rare and usually untreatable forms of childhood epilepsy.

In trials, patients taking Epidiolex saw their monthly seizures reduced by about 40 percent. Several conservative states with draconian drug laws, including Texas, now allow severely ill people to access CBD oil, though with significant restrictions. The drugs, which are approved to treat nausea from chemotherapy and other conditions, are listed at Schedule III and Schedule II, respectively.

But it's also good for cannabis, which appears to be a medicine, according to agents of the USA federal government. Just as we all knew. "America clearly is moving, more so, and embracing cannabis as something that can be used medicinally".

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