FDA Approves Medicine Containing Cannabis for the First Time

FDA approves first cannabis-based drug	 	 	 			Courtesy CNN

The chemical used in Epidiolex, cannabidiol, is a component of the cannabis sativa plant, but does not carry the same psychoactive effects or "the high" that results from pure tetrahydrocannabinol (THC) consumption.

"Today's approval of EPIDIOLEX is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies", said Justin Gover, GW's Chief Executive Officer.

The move marks several firsts.

The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle.

New approved drug is syrup-like medicine, which contains cannabidiol (CBD) as an active ingredient.

FDA Commissioner Scott Gottlieb issued a separate statement stressing the importance of proper research on medical uses of marijuana and cautioning other companies that might try to push their pot treatments.

"This is the first time the government has approved a compound derived from the cannabis plant to treat any disorder - in this case, severe epilepsy due to Dravet and Lennox Gastaut syndromes".

The drug's effectiveness was studied in clinical trials with 516 patients and when taken with other medications, Epidiolex was shown to be effective in reducing the frequency of seizures when compared with placebo.

"This research process - from early development through preclinical and clinical research - gives us a comprehensive understanding of a new drug", he said.

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If experts are to be believed, Epidiolex is key breakthrough by GW Pharmaceuticals - one that is likely to aid hundreds of children suffering from epilepsy.

Epidiolex is reportedly an oral solution meant to treat seizures that are known to be associated with two particular types of epilepsy, the Lennox-Gastaut syndrome, and Dravet syndrome, for children 2 years old and above.

More than 90 percent of patients with LGS or Dravet syndrome have multiple seizures per day, which puts them at constant risk for falls and injury.

It's an option for those patients who have not responded to other treatments to control seizures. But Garris highlighted that numerous side effects occur when it is taken with other medications, which she said is a concern because most patients are on other medications.

The most common side effects of Epidiolex include diarrhea, rash, insomnia, and infections.

"And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition", he continued.

The company has not announced pricing for the drug, but Wall Street analysts previously predicted it could cost as much as $25,000 per year.

"The DEA will need to make a different scheduling decision for CBD.because it now has an accepted medical use", he said during a conference call with reporters.

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