FDA Approves First Cannabis Based Drug

The drug's approval permits its use in patients aged two years and older with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), rare childhood-onset forms of epilepsy that are among the most resistant to treatment. "Epidiolex has been studied and proven to significantly reduce seizures so, in a few short months, it will be a new and welcome product for doctors to consider for their patients in need". Though CBD doesn't induce the high associated with marijuana use-THC does that-it's now classified as Schedule I, a category that covers drugs with no therapeutic value and high probability of abuse. Until now, the Drug Enforcement Administration has classified CBD as a Schedule 1 substance.

"This is an important medical advance", Gottlieb said.

Fox hailed Monday's FDA action as a win for the broader medical marijuana community, in that it will facilitate more clinical research into the drug's medical benefits. The CBD oil derived from the marijuana plant has been administered to relieve insomnia, anxiety and chronic pain, as well as to treat multiple sclerosis and Parkinson's disease, among conditions, wrote Harvard Medical School professor Dr. Peter Grinspoon.

Shlomo Shinnar, president of the American Epilepsy Society and a neurologist at Montefiore Medical Center in NY, has said the drug will be "a very valuable addition" to the limited options for treating severe childhood-onset epilepsy.

Currently, some state laws prevent any cannabis-derived drug from being sold in pharmacies.

Epidiolex won't require a special certification to prescribe, Patel said, and it's likely physicians will prescribe it for off-label uses.

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Although THC can induce paranoia, anxiety and hallucinations, CBD has the opposite effect and has been cited by scientists as a potential treatment for mental health issues. "There's no time line or clock that starts ticking on us".

Another 20 states allow medical marijuana, but the US government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.

That's according to Steve Fox, the director of VS Strategies, which was retained by GW Pharmaceuticals to assist with lobbying and public relations efforts. 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 that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.

"For a maligned substance like cannabis, I think the vindication tour will ultimately be years long", said Ricardo Baca, a former marijuana editor at the Denver Post, and the founder of Grasslands, a cannabis PR agency. The decision caps decades of work by the company to gain approval in the US for a medicine derived from the cannabis plant. That decision is expected within 90 days.

For their part, GW Pharmaceuticals executives say they are not trying to disrupt products already on the market.

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