Published: Tue, June 26, 2018
Health Care | By Oscar Goodwin

FDA approves cannabis-derived medicine; DEA must weigh in


The drug, administered as an oil, could significantly improve the quality of life for patients with two types of childhood epilepsy: Dravet syndrome, a genetic illness that kills up to 20 percent of sufferers before age 20, and Lennox-Gastaut syndrome, a form that begins between ages 3 and 5 and causes intellectual disability. "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".

The FDA news signals that the DEA will likely adjust its scheduling for CBD, which is now a Schedule I substance, denoting high potential for abuse and no medical applications.

First, the FDA must confer with the Drug Enforcement Administration to decide when to "reschedule" cannabidiol, better known as CBD, Devinsky said.

He added, "This is how sound medical science is advanced". The drugmaker is testing other CBD treatments for glioblastoma and schizophrenia. But it's not quite medical marijuana. "And, the FDA is committed to this kind of careful scientific research and drug development", said Gottlieb.

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"Compared to other drugs used to treat epilepsy, I think Epidiolex, which is 99-percent pure cannabidiol, has a better side-effect profile than numerous available drugs", Devinsky said. Shinnar said he will welcome approval of a medicine that had undergone stringent FDA review for safety and effectiveness.

That's because these kids did not experience as many side effects from the cannabidiol, which can include tiredness, decreased appetite, diarrhea and signs of possible liver damage, Devinsky explained.

In the meantime, it is possible that once on the market, Epidiolex could be prescribed for conditions other than the ones it's approved for.

Medical marijuana is available in about half of the states.

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The drug is derived from the cannabidiol of cannabis, and, as the plant is yet to be decriminalized by federal regulators, its approval gives GW Pharma a lead among cannabis-exposed companies in the USA financial markets.

"Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", he said. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.

Some have said that they have no intention of switching to the new prescription CBD drug because the products they're using are helping their children.

The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the US subsidiary of GW Pharmaceuticals. That decision is expected within 90 days. Others said they are anxious to try an FDA-approved product.

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"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.

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