FDA approves first prescription drug made from marijuana


In one study of 120 children and young adults with Dravet syndrome, cannabidiol reduced the median frequency of convulsive seizures to 5.9 a month from 12.4 before treatment, while patients getting a placebo saw minimal reductions, according to results published a year ago in the New England Journal of Medicine.

A new epilepsy medicine derived from cannabis could be in the hands of patients before any medical marijuana reaches the shelves in Ohio.

But before the medicine can hit the market in those areas, the Drug Enforcement Administration must reclassify marijuana, now a Schedule I drug, along with heroin and Ecstasy, that is described as a substance with "no now accepted medical use and a high potential for abuse".

Now that Epidiolex is approved by the FDA, cannabidiol is expected to be reclassified by the Drug Enforcement Administration within 90 days.

"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", Gottlieb said.

It's an option for those patients who have not responded to other treatments to control seizures.

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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. "And, the FDA is committed to this kind of careful scientific research and drug development", FDA Commissioner Scott Gottlieb, M.D, said. It's just a gray area, and many are erring on the side of caution and not doing business in those states. But unlike tetrahydrocannabinol, or THC, it does not produce a high.

Carson says he will likely prescribe Epidiolex going forward.

Why? Because their product and company status will no longer exist in the legal gray area, and hopefully the mass confusion over which CBD products are legal and which are not will come to an end.

In some cases, patients have moved to states that have legalized medical marijuana in order to have access to the drug. "There's no time line or clock that starts ticking on us". United Kingdom -based GW Pharmaceuticals says the solution, taken by mouth, is made from a proprietary strain of cannabis created to maximize a therapeutic component while minimizing components that produce euphoria.

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. Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy. The company has not yet set a price for the drug and said it would work with insurance providers to ensure the medicine would be covered under health plans.

The FDA's decision is historic but it is not unexpected. Experts expect to see an uptick in cannabidiol-related products out of Canada, particularly with this week's nationwide legalization of marijuana.