Marijuana-based drug for childhood seizures moves closer to approval in US

Marijuana-based drug for childhood seizures moves closer to approval in US

GW Pharmaceuticals Plc's cannabis-derived drug to treat a severe form of childhood epilepsy was unanimously backed on Thursday by an advisory panel to the U.S. Food and Drug Administration. The company's medicine is made from a chemical found in the cannabis plant - one that does not get users high. FDA staff were also positive on the treatment, saying in a report ahead of the meeting that the United Kingdom -based drugmaker provided "substantial evidence" of Epidiolex's effectiveness.

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 13-0 in favour of approving Epidiolex (cannabidiol), for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients two years of age and older.

In studies, CBD oil from GW Pharmaceuticals has been shown to reduce seizures dramatically.

FDA regulators are due to make their decision by late June.

In fact, the federal government now lists it alongside other drugs such as heroin and cocaine as a Schedule I substance, indicating that it is more unsafe than opioids.

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The FDA's approval would limit the treatment to a small group of epilepsy patients, but doctors would have the option to prescribe it for other uses.

The acceptable safety risks included liver injury, which it said can be managed and monitored.

GW stock was halted just ahead of the announcement.

A study involving children with Dravet's syndrome saw five percent becoming seizure free while taking Epidiolex. "In this case, if FDA approves this and sends over a request that we schedule it. we are bound by the science provided to us by [the Department of Health and Human Services], whether it's FDA, [National Institute on Drug Abuse], whoever - all that science would come over to us and we would use that science to determine which schedule to put it in".

While the panel of experts who met Thursday determined the drug "appears to support approval", they were concerned about the potential side effects, which include diarrhea, vomiting, fatigue and sleep problems.

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