The FDA Approves the First Cannabis-Based Medicine

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As noted in a prior posting on this Website, an FDA Advisory Committee issued the first ever positive recommendation for a plant-based pharmaceutical cannabidiol product in April of 2018, when the committee recommended approval of the investigational cannabidiol oral solution known as Epidiolex® to treat seizures in patients with severe forms of epilepsy.

Epidiolex is approved to treat Lennox-Gastaut and Dravet syndromes in patients age two or older. Therefore, patients will not be able to access Epidiolex until CBD is rescheduled by the DEA, which is expected to take place within 90 days, according to GW Research Ltd. Epidiolex is the first cannabis-based drug to be legalized in the United States.

The US regulator said that Epidiolex is also the first approved drug for the treatment of patients with Dravet syndrome. 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. The trials included 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome.

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Epidiolex is made from purified cannabidiol (CBD), an ingredient found in marijuana. Alan also expects that there will be more CBD products and other medications derived from cannabinoids on the market. "These patient populations desperately need new treatment options to help control their seizures and the results of the clinical trial in both disorders are very promising".

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. As of last week, the company hadn't determined the price but was in preliminary talks with insurance companies to make them aware Epidiolex is coming, he said.

The FDA has previously approved synthetic versions of another cannabis ingredient for medical use, including severe weight loss in patients with HIV. "And, the FDA is committed to this kind of careful scientific research and drug development", said FDA Commissioner Scott Gottlieb, M.D.

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Gottlieb went on to say that the FDA will support further scientific studies involving the therapeutic potential of marijuana-derived products.

"I believe there is going to be an even larger emergence of CBD [and other marijuana] companies touting their [products] as beneficial and using this approval as their basis, " said Kelvin Harrylall, the CEO of the CBD Palace, which audits CBD companies and creates a list of vendors it deems safe for customers. FDA has determined that CBD has negligible abuse potential.

Industry supporters downplayed the impact of the FDA approval. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.

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