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US experts support marijuana-based drugs for childhood seizures



WASHINGTON (AP) – A drug made from marijuana has come one step closer to US approval after federal health advocates have advocated treating severe seizures in children with epilepsy ,

If the Food and Drug Administration follows the group's recommendation, the GW Pharmaceuticals syrup would be the first drug derived from the cannabis plant to be approved in the US

The 13-member FDA panel voted unanimously in favor on the experimental medication made from a chemical found in cannabis – one that does not keep users high. Participants confirmed the drug on the basis of three studies that showed it significantly reduced seizures in children with two rare forms of childhood epilepsy.

"This is clearly a breakthrough drug for a terrible disease," said panel member Dr. John Mendelson from the Friends Research Institute in Baltimore, Maryland.

The drug carries a potential risk of liver damage, but panelists said doctors could monitor patients for any signs. Other common side effects included diarrhea, vomiting, fatigue and sleep disturbances.

FDA regulators will make their decision in late June. The approval would technically limit the drug Epidiolex in patients with difficult-to-treat forms of epilepsy. But doctors would have the opportunity to prescribe it for other uses, and it could spur new pharmaceutical research and interest into other cannabis-based products.

More than two dozen states allow marijuana for a variety of complaints, but the FDA did not approve it for any medical use. The FDA has approved synthetic versions of another cannabis ingredient for other medical purposes.

Several patients and parents spoke at the Thursday meeting about the benefits of Epidiolex. Sam Vogelstein, 16, said he experienced daily seizures – sometimes more than 100 a day – before enrolling in a study of the drug.

"I only went to South Africa for two weeks without my parents on a school outing," said Vogelstein, who lives in Berkeley, California. "I could not have done that if I had not tried this medicine."

It is not yet clear why the drug reduces seizures.

Epidiolex is essentially a pharmaceutical version of cannabidiol or CBD oil. which some parents have been using for years to treat children with epilepsy. CBD is one of more than 100 chemicals found in the cannabis plant and contains no THC that provides marijuana with its mind-expanding effects.

CBD oil is currently sold online and in specialty stores across the country Legal status remains bleak. Most manufacturers say their oil is made from hemp, a form of cannabis that contains little THC and can be legally grown in a number of countries for clothing, food and other uses.

It is unclear how the FDA approval of a CBD drug would affect products already on the market. Executives of the British pharmaceutical company GW Pharmaceuticals say that their goal is to deliver a standardized, research-based version.

"We do not want to influence the availability of other products on the market," said GW boss Steve Schultz before the meeting. "Our goal is to provide an additional option for patients and physicians who wish a purified version of CBD for the treatment of seizures."

The company did not want to comment on the price of the drug before the approval decision. Wall Street analysts estimate it could cost more than $ 25,000 a year.

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The Associated Press Health & Science Department receives support from the Department of Science Education of the Howard Hughes Medical Institute. The AP is solely responsible for all content.

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Matthew Perrone can be followed on Twitter: @ AP_FDAwriter


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