FDA Approves The First Marijuana-Derived Drug For Childhood Epilepsy

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Previous year a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health.

GW Pharma won't be able to launch the drug right away, however, because its active ingredient, CBD, needs to be rescheduled by the DEA. 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.

The FDA previously cleared medications containing synthetic versions of THC for nausea for patients getting chemotherapy and for other uses, but it had not approved any drug derived from the plant itself.

The federal thumbs-up comes on the heels of several months of promising research results and a positive preliminary vote from the Food and Drug Administration this spring.

In clinical trials, children with Dravet syndrome who took Epidiolex experienced 39 percent fewer seizures; those with Lennox-Gastaut syndrome saw a 37 percent decrease. "And the FDA is committed to this kind of careful scientific research and drug development", Gottlieb concluded. The conditions typically begin in childhood, with frequent or prolonged seizures, and patients have a high risk of death from seizure-related causes and infections. Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade CBD. While CBD has purely medicinal purposes, the other compound, tetrahydrocannabinol (THC), is what gives marijuana users the psychoactive effects commonly associated with the plant. It is currently a Schedule 1 drug, along with heroin, because of abuse potential, but GW expects Epidiolex to have a less restrictive DEA scheduling because of studies showing minimal abuse potential and now an approved medical use. But it's not quite medical marijuana.

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CBD is the common abbreviation for cannabidiol, a chemical derived from cannabis.

"I'm really happy we have a product that will be much cleaner and one that I know what it is", said Dr. Ellaine Wirrell, director of the Mayo Clinic's program for childhood epilepsy.

"I preferred this to some of those other options because it's is a commercial product that has gone through rigorous testing", said Hendershot, who lives in Rochester, New York.

The FDA's decision is historic but it is not unexpected.

For their part, GW Pharmaceuticals executives say they are not trying to disrupt products already on the market. According to the agency's website, the FDA "is aware that there is considerable interest in [marijuana's] use to attempt to treat a number of medical conditions, including, for example, glaucoma, AIDS wasting syndrome, neuropathic pain, cancer, multiple sclerosis, chemotherapy-induced nausea, and certain seizure disorders". "There's no time line or clock that starts ticking on us". "Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases".

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