FDA approves first marijuana-based epilepsy medication

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The drug contains cannabidiol, or CBD, a substance derived from marijuana, but causes no intoxication, euphoria or "high", the FDA said.

"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.

Doctors hope it will be available in pharmacies by 2019. ABC News also confirmed this expected timeline with Christy Curran, spokesperson for GW Pharmaceuticals.

That could accelerate the process of outlawing or allowing new drugs as they pop up. What's more, the DEA will reportedly reschedule CBD in light of the FDA's decision, greatly loosening restrictions on research.

He said there are thousands of parents with children having daily seizures who want all medical treatments explored, even those involving cannabis.

Most patients with LGS and DS require multiple seizure medications and the majority are resistant to now approved anti-epileptic drugs.

News that recreational marijuana will be legal in Canada starting October 17th, 2018 has seemingly made a positive impact on the United States' Food and Drug Administration.

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"The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific channels", FDA Commissioner Scott Gottlieb said in a Monday press release. A study at the end of past year found that almost 70 percent of CBD products sold online were mislabeled. 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.

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 FDA still hasn't given its blanket approval to marijuana as a "safe and effective drug", though it has OK'd three medications that contain synthetic compounds similar to those found in the marijuana plant.

Epidiolex will be marketed by Greenwich Biosciences, a subsidiary of GW Pharmaceuticals. Despite the medication's approval, cannabis remains a Schedule I substance, which, according to the federal government, means it has "no accepted medical uses". There are only a few pharmaceutical treatments for patients living with Lennox-Gastaut, no pharmaceutical options for those living with Dravet syndrome.

The U.S. approval for Epidiolex was largely expected after an FDA advisory panel endorsed it with a 13-0 vote in April.

Gottlieb emphasized that the approval of Epidiolex does not have any implications for the approval of marijuana as a medicine more broadly, but the move is still widely seen by the industry as a significant step towards acceptance of the cannabis plant.

Treatments available for both disorders are far from flawless and some patients resort to buying "self-prescribed" CBD online or from unregulated vendor sites, Dr. Pavel Klein, founder of the Mid-Atlantic Epilepsy and Sleep Center, said.

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