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CBD-Based Epidiolex Gets FDA Approval for Seizure Disorders

The United States Food and Drug Administration (FDA) made a bold move last month as they gave approval to a CBD based medicine called Epidiolex, which was created by GW Pharmaceuticals. The British pharmaceutical company has been working on cannabis-based medicines overseas for years – but Epidiolex went through extensive clinical trials that were subjected to review by the FDA.

The trials looked specifically at Epidiolex ability to treat intractable forms of epilepsy, Dravet Syndrome and Lennox-Gastaut Syndrome – and for both conditions there were undeniable benefits. Impressively, Epidiolex is also the first ever approved medication for Dravet syndrome.

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D.

Getting approval from the FDA means a few things – but most importantly, it gives patients with severe epilepsy a new treatment option that was only available to them in limited states before that. Now, any doctor will be able to prescribe Epidiolex to treat these and other rare forms of Epilepsy, regardless of whether CBD oil or medical marijuana has been legalized by state law.

It could also mean a wave of change coming to the United States government – where other agencies like the Drug Enforcement Administration (DEA) have continuously denied petitions to reschedule cannabis in the Controlled Substances Act (CSA).

However, as it stands right now, the CSA deems that cannabis has no medicinal value – yet another government agency, the FDA, is now saying this is untrue.

CBD is a cannabis derivative, and if the FDA has found that it has medicinal value, then the DEA’s determination on cannabis – which dates back to the 70s and even further for politically motivated reasons – now conflicts with the governments own findings.

“We’ll continue to support rigorous scientific research on the potential  medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products.”

While the FDA approving Epidiolex is not going to immediately create access for all patients needing access to CBD, it is certainly a huge step in the right direction. It is going to take time, and other clinical trials on the same scale for other medicines like Epidiolex to make their way into pharmacies – but this is the start many patients have been waiting for.

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*The statements have not been evaluated by the Food and Drug Administration. The products are not intended for the cure, diagnosis, mitigation, treatment, or prevention of disease in man or animal.