Tuesday, 17 July, 2018

The FDA May Approve Its First Cannabis-Based Drug This Week

Anna Jefferson | 26 June, 2018, 09:26

A new drug derived from marijuana just became the first of its kind to get the green light from the USA government.

Before sales of Epidiolex can begin, the Drug Enforcement Administration must formally reclassify CBD into a different category of drugs that have federal medical approval.

Epidiolex is manufactured by the British firm GW Pharmaceuticals, which funded the clinical trial. Many individuals report experiencing relief from epilepsy symptoms after smoking a high CBD strain of cannabis or consuming CBD pills, which exclusively or primarily contain cannabidiol.

While the FDA had not previously approved any drug directly deriving from marijuana, it has marketed some containing a synthetic version of THC.

"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".

In fact, this was the third clinical trial to show that Epidiolex is useful in treating two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, Devinsky said. Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade CBD.

A GW Pharmaceuticals spokeswoman said the company would not immediately announce a price for the drug, which it expects to launch in the fall.

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"For a maligned substance like cannabis, I think the vindication tour will ultimately be years long", said Ricardo Baca, a former marijuana editor at the Denver Post, and the founder of Grasslands, a cannabis PR agency. She has not used Epidiolex in her own clinical practice and was not involved in the development of the drug but said she's not sure it will live up to "all of the hype" that has surrounded it.

"I'm really happy we have a product that will be much cleaner and one that I know what it is", Wirrell told the Associated Press.

Commenting on the agency's decision, NORML Deputy Director Paul Armentano said: "The FDA's approval of this plant-derived medicine provides an additional option to patients seeking the therapeutic benefits of cannabis".

Treatments available for both disorders are far from flawless and some patients resort to buying "self-prescribed" CBD online or from unregulated vendor sites, Dr. Pavel Klein, founder of the Mid-Atlantic Epilepsy and Sleep Center, said.

"The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", Gottlieb said. Dravet syndrome is estimated to effect about 1 in 40,000 people.

The FDA is not required to follow the advisory panel's advice but usually does. The company has not yet set a price for the drug and said it would work with insurance providers to ensure the medicine would be covered under health plans. Those taking 20 mg of Epidiolex a day had 42 percent fewer seizures, on average, compared with 37 percent fewer seizures in the group taking 10 mg of the drug, and a 17 percent reduction in the placebo group.

The FDA's decision is historic but it is not unexpected. European approval is expected in early 2019.

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