US approves marijuana-based drug for seizures

But it's not quite medical marijuana.

A flowering marijuana plant is pictured at the Canopy Growth Corporation facility in Smiths Falls, Ontario, Canada, January 4, 2018. 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. He added that the drug offers families "the first and only FDA-approved cannabidiol medicine to treat two severe, childhood-onset epilepsies". "And, the FDA is committed to this kind of careful scientific research and drug development".

"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", said Food and Drug Administration Commissioner Scott Gottlieb. "I am delighted that my physician colleagues and I will now have the option of a prescription cannabidiol that has undergone the rigor of controlled trials and been approved by the FDA to treat both children and adults". GW won't be able to market Epidiolex until the DEA reclassifies CBD. CBD is one of more than 100 chemicals found in marijuana. It contains only trace amounts of the psychoactive element THC and does not induce euphoria.

Side effects with the drug include diarrhea, vomiting, fatigue and sleep problems. A bill was introduced to the House past year to legalize the use of marijuana, but it has yet to reach the floor for vote.

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.

Carson says he will likely prescribe Epidiolex going forward. And, as NPR has reported, CBD supplements are available widely online and in dispensaries in the form of oils or tinctures.

FDA's Gottlieb warned about the use of CBD products with "unproven medical claims".

It is estimated there are up to 18,500 patients with LGS, and 20,000 of Dravet Syndrome in the United states. The FDA has previously sent warning letters to companies that hyped their products as cancer or Alzheimer's fighters. It is the fourth marijuana-based medicine to receive US FDA approval - joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros).

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The FDA seal is nonetheless seen to be a boon for the broader industry. "We're the world-leaders in cannabinoid science, and I think we expect to stay there for quite some time".

Jackson's group estimates the typical family using CBD to treat childhood epilepsy spends about $1,800 per year on the substance.

That's according to Steve Fox, the director of VS Strategies, which was retained by GW Pharmaceuticals to assist with lobbying and public relations efforts.

For their part, GW Pharmaceuticals executives say they are not trying to disrupt products already on the market.

This drug is a treatment option of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

Although several states have legalized the medical and recreational use of marijuana, the federal agency had yet to do so until today.

Despite increasing acceptance, there is little rigorous research on the benefits and harms of marijuana.

"The FDA prepares and transmits... a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the [Controlled Substances Act]", the FDA stated, indicating that it will recommend that CBD be rescheduled but the act of shifting the substance's legality is ultimately in the DEA's hands. "The role of DEA at this point is to be involved in determining the appropriate schedule for Epidiolex". The decision caps decades of work by the company to gain approval in the US for a medicine derived from the cannabis plant.

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