FDA Approves First Cannabis CBD Drug to Treat Severe Epilepsy

FDA approves first cannabis-based drug

FDA approves first cannabis-based drug

The FDA approved the cannabidiol to treat patients aged two and older with rare and severe forms of epilepsies namely, Lennox- Gastaut syndrome and Dravet syndrome.

There are other drugs inspired by compounds in marijuana on the market - like Marinol, a synthetic cannabinoid that's used to treat nausea and vomiting from chemotherapy - but Epidiolex is the first that's been approved by the FDA and created from an actual marijuana plant and not made synthetically. Although medicinal use of cannabis is not legal in all U.S. states, the market for CBD is now estimated to be worth $200m, having doubled in size over the last two years as more investors look to cash in on the buzz around CBD.

The US regulator said that Epidiolex is also the first approved drug for the treatment of patients with Dravet syndrome.

Dravet syndrome appears in early childhood causing frequent seizures, impaired motor skills, and hyperactivity.

FDA commissioner Scott Gottlieb said the drug was an "important medical advance" but cautioned that approval did not cover medicinal cannabis, which is legal in some USA states but not in others. Outside the US, this medicine is now under review by the European Medicines Agency (EMA) for the treatment of seizures associated with Dravet Syndrome and LGS. Neither Nebraska nor South Dakota allows medical use of marijuana, and activists accused the company of trying to shut down future access to products containing cannabidiol but lacking FDA approval.

It has high mortality rate than other types of epilepsy and do not respond to any other drugs available.

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Marijuana has always been known to be effective in reducing the frequency of seizures in some patients; and many patients buy medical grade marijuana in states where it is legal as treatment.

It was observed that in combination with other medications, Epidiolex reduced the frequency of seizures as compared to placebos.

Epidiolex is now classified as a Schedule I substance because it is a chemical component of the cannabis plant. However, with Epidiolex, patients will be able to get a high-grade, medically regulated dosage each time they take it.

The decision follows a unanimous vote in favour of the approval by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee. The FDA's warnings reminded these producers that only FDA-approved products that have gone through rigorous clinical trials can make such claims. A milestone for the medical cannabis community, news of the approval sent GW's prices skyrocketing, with the company closing the day up 1.21 percent, and up a whopping 6.34 percent in after-hours trading. He also reaffirmed that "the FDA is committed to this kind of careful scientific research and drug development".

FDA Commissioner Dr. Scott Gottlieb said in a statement, "This is an important medical advance".

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