ibusinesslines.com September 21, 2018

FDA Green Lights Marijuana-Based Pharmaceutical Drug

26 June 2018, 03:26 | Melissa Porter

US health regulators approve seizure drug made from marijuana

FDA approves first cannabis-based drug

Called Epidiolex, the GW Pharmaceuticals drug is created to treat two rare forms of childhood epilepsy using a marijuana compound called CBD. One in five patients is estimated to die before they are 20 years old.

GW Pharmaceuticals said it expected to make the product available by the fall, pending expected action by the Drug Enforcement Administration to reclassify the drug.

Nasdaq-listed GW Pharmaceuticals, which grows its own marijuana plants in glass houses in Britain, hopes the drug will be approved in the United Kingdom next year.

As the FDA itself notes, "this is the first FDA-approved drug that contains a purified drug substance derived from marijuana". 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.

"This approval serves as a reminder", Scott Gottlieb, the FDA commissioner, said in a statement on Monday, "that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies".

The FDA approval for Epidiolex is technically limited to patients with Dravet and Lennox-Gastaut syndromes, two rare forms of epilepsy for which there are few effective treatments.

With Epidiolex meeting FDA standards, the drug will "finally be made available to the thousands that may benefit from it", he said.

According to Dr. Angel Hernandez, of the Helen DeVos Children's Hospital in Grand Rapids, Mich., these results prove that pharmaceutical-grade CBD helps suppress seizures and "increases our options to treat many of these patients with very, very difficult-to-control epilepsies". 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. Most producers say their oil is made from hemp, a plant in the cannabis family that contains little THC and can be legally farmed in a number of states for clothing, food and other uses.

Some experts believe the anticipated approval will likely open the floodgates for product demand of other CBD products, and place further pressure on the FDA to move it along and approve other CBD-based medications. Marijuana and its components, including CBD, are Schedule 1 controlled substances - meaning they are banned because they are thought to have a high abuse potential, no medical value and serious safety implications.

The U.S. approval for Epidiolex was largely expected after an FDA advisory panel endorsed it with a 13-0 vote in April.

That's because these kids did not experience as many side effects from the cannabidiol, which can include tiredness, decreased appetite, diarrhea and signs of possible liver damage, Devinsky explained.

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 FDA previously cracked down on CBD companies for claiming their products could treat cancer and other conditions.

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