Published: Tue, June 26, 2018
Medical | By Marta Holmes

FDA Approves The First Marijuana-Derived Drug For Childhood Epilepsy

FDA Approves The First Marijuana-Derived Drug For Childhood Epilepsy

Following a successful trial in May that proved the drug reduced seizure frequency by 40 percent, Epidolex will become the first FDA-approved medicine to include cannabidiol, or CBD, a non-psychoactive chemical found in the marijuana plant.

For the first time, the FDA approved a drug derived from the marijuana plant, and it could help patients with rare forms of epilepsy. But some parents worry it could hurt Colorado's cannabidiol (CBD) industry already helping children who are suffering from seizures. Where is weed legal?

GW Pharmaceuticals said it expected to make the product available by the fall, pending expected action by the Drug Enforcement Administration to reclassify the drug.

A drug made from a derivative of marijuana has been approved for patients with certain forms of epilepsy.

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In three large clinical trials which the FDA considered before giving Epidiolex the official green light, researchers presented strong evidence that the pharmaceutical-grade CBD in the medicine had the power to significantly curb some of the worst symptoms of two of the hardest-to-treat forms of epilepsy, known as Lennox-Gastaut syndrome and Dravet syndrome.

Since receiving Epidiolex, Hendershot says her daughter has been able to concentrate more and has had fewer "drop" seizures - in which her entire body goes limp and collapses. Most producers say their oil is made from hemp, a plant in the cannabis family that contains little THC and can be legally farmed in a number of states for clothing, food and other uses. And like other drugs that treat epilepsy, Epidiolex will come with a special warning that use may be tied to a higher odds of depression, aggression and suicidal thoughts.

In a statement accompanying Monday's approval announcement, the FDA hastened to note that it's not signing off on the safety or medical utility of marijuana in general ― just this one compound and only for this limited use.

"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. Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy.

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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.

Despite increasing acceptance, there is little rigorous research on the benefits and harms of marijuana.

But doctors will have the option to prescribe it for other uses. A prescription drug provides a workaround to this issue. A year ago a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health. Experts are hopeful that the approval will unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds.

As a result, Epidiolex's launch remains at the discretion of the DEA which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, which would allow GW to begin selling it. European approval is expected in early 2019.

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