Sunday, 22 July, 2018

FDA approves first marijuana-based epilepsy medication

FDA approves first cannabis-based drug KIVI via CNN
Johnnie Parks | 26 June, 2018, 15:26

The U.S. Food and Drug Administration approved Epidiolex, a cannabidiol oral solution for the treatment of seizures related to epilepsy.

An estimated 30,000 children and adults suffer from Lennox-Gastaut syndrome, and fewer from Dravet syndrome.

The drug is derived from the cannabidiol of cannabis, and, as the plant is yet to be decriminalized by federal regulators, its approval gives GW Pharma a lead among cannabis-exposed companies in the US financial markets. This drug does not contain THC, which is the part of the marijuana plant that would get someone high.

"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", FDA Commissioner Scott Gottlieb said.

Now with the approval of Epidiolex, a drug that will not produce an euphoric "high" feeling in the user - Devinsky said he expected CBD would be moved down to a schedule 4 or 5 drug, which is one that poses a low potential for abuse and dependence.

"For those living with intractable seizures caused by LGS and Dravet syndrome, Epidiolex represents a true medical advancement", said Philip Gattone, president and CEO of the Epilepsy Foundation.

Patients are concerned that changes to state laws to allow for the first cannabis-derived medication in pharmacies could limit their access to cannabis medicine at dispensaries. The agency has previously approved drugs made from synthetic versions of THC and other marijuana constituents.

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A drug made from a derivative of marijuana has been approved for patients with certain forms of epilepsy.

In a statement accompanying Monday's approval announcement, the FDA hastened to note that it's not signing off on the safety or medical utility of marijuana in general ― just this one compound and only for this limited use. The British drugmaker studied the drug in more than 500 patients with hard-to-treat seizures, overcoming numerous legal hurdles to conducting research with cannabis.

Ohio's medical marijuana program was expected to be operational in early September but now has no definite start date, and none of the approved cultivation centers has begun growing the plant. However, it isn't clear whether such a reclassification would involve CBD products in general, the CBD formulation used specifically in Epidiolex or something else.

"Clinical development for these rare and severe conditions is essential, and today's news brings hope for these patients and their families that a new treatment option may have the potential to help better control their seizures".

The Drug Enforcement Administration must reclassify cannabidiol before GW Pharma can market Epidiolex.

Shauna Garris, a pharmacist, pharmacy clinical specialist and adjunct assistant professor at the University of North Carolina's Eshelman School of Pharmacy, said the drug is effective and works somewhere between "fairly" and "very well". Past year a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health.

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