FDA Approves First Marijuana-Derived Drug

FDA approves first ever drug derived from marijuana | TheHill

The FDA paid attention, and Monday approved Epidiolex, the first-ever prescription drug derived from marijuana. Humboldt marijuana growers tighten belts for legalizationThe strawberry-flavored syrup is a purified form of a chemical in the cannabis plant - but not the one that gets users high.

Dr. Anup Patel, neurology section chief at Nationwide Children's Hospital in Columbus, said Monday's announcement is good news for epilepsy patients who have been waiting for relief from the state's 2016 medical marijuana law or have been experimenting with unregulated products claiming to contain CBD.

GW Pharmaceuticals, the British company responsible for the drug, said now approved AEDs (anti-epileptic drugs) are not always effective in the majority of patients with Lennox-Gastaut Syndrome (LGS) and Dravet syndrome - severe forms of childhood-onset epilepsy.

Most patients with LGS and DS require multiple seizure medications and the majority are resistant to now approved anti-epileptic drugs. What's more, the DEA will reportedly reschedule CBD in light of the FDA's decision, greatly loosening restrictions on research.

"This approval serves as a reminder that sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies", Gottlieb told reporters.

The FDA took pains to specify that clearing Epidiolex for use is not an approval of marijuana or any of its components.

Gover said the approval signals "validation of the science of cannabinoid medication".

"I hope patients have conversations with their physicians about whether this product (Epidiolex) provides them with treatment they have been looking for with other unapproved products", said Douglas Throckmorton, deputy director of regulatory programs at the FDA's Center for Drug Evaluation and Research. The medication has been approved for patients aged two years or older and marks the first time the agency has approved a drug derived from cannabis.

GW Pharmacueticals is expected to announce the US launch for Epidiolex as soon as the DEA reclassifies CBD.

The FDA is approving this new drug, despite it still being considered a Schedule 1 drug by the Drug Enforcement Agency. Other companies working with cannabidiol include AXIM Biotechnologies and Cure Pharmaceutical. GW won't be able to market Epidiolex until the DEA reclassifies CBD.

Several researchers are studying the potential of CBD to treat psychiatric conditions.

"We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant", Armentano continued.

It's meant to treat severe seizures in children caused by two rare forms of epilepsy.

The FDA is not required to follow the advisory panel's advice but usually does. 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. Another 20 states allow medical marijuana, but the US government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.

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