January 22, 2019

For first time ever, FDA approves marijuana-derived medicine

27 June 2018, 01:31 | Randall Craig

Marissa Parsons who has Lennox Gastaut syndrome visits the Grand Canyon with her family in 2016

Marissa Parsons who has Lennox Gastaut syndrome visits the Grand Canyon with her family in 2016

United States regulators on Monday approved the first marijuana-derived drug ever to hit the USA market, Epidiolex, which will be used to treat two rare and severe forms of childhood epilepsy.

Humboldt marijuana growers tighten belts for legalizationThe strawberry-flavored syrup is a purified form of a chemical in the cannabis plant - but not the one that gets users high.

CBD acts on different parts of the nervous system compared with THC.

"And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition", he continued. 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.

GW Pharmaceuticals, the British company responsible for the drug, said now approved AEDs (anti-epileptic drugs) are not always effective in the majority of patients with Lennox-Gastaut Syndrome (LGS) and Dravet syndrome - severe forms of childhood-onset epilepsy. Carreno says that a leader drug like Epidiolex often paves the way for other less expensive-and untested-CBD products. It's not yet clear why the ingredient, known as CBD, reduces seizures in some people. "Yet we were surprised at how robust the response was in this study", Dr. Anup Patel, a pediatric neurologist at Nationwide Children's Hospital in OH and one of the lead authors of the study, told ABC News.

Dravet syndrome is a rare genetic condition that causes frequent fever-related seizures, involuntary muscle spasms and a potentially life-threatening state of continuous seizure activity requiring emergency medical care. In clinical trials, patients administered Epidiolex, on average, obtained a 40 percent reduction in seizure frequency.

A doctor talks to a patient in this undated stock photo.

Epidiolex's effectiveness was studied in three randomized clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome, comparing Epidiolex to a placebo.

There are side effects, the most common being sleepiness, Gover said. "I really don't think it's going to affect us much". In contrast to THC, the far more popular cannabinoid CBD does not produce strong psychoactive effects when consumed.

"The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", Gottlieb said. It may also have far-reaching implications for US marijuana policy. A prescription drug provides a workaround to this issue. But federal regulations classify CBD as a Schedule 1 drug, similar to heroin and cocaine, because it is a chemical component of the cannabis plant. The agency is expected to do so within 90 days.

"We don't expect to know the price until the fall, but over the coming weeks, we'll work with setting a price with the insurance providers".

What should parents be aware of now?

A government-regulated version of the oil will ease some doubts about the amount of CBD in the product, which can vary based on its origin, said Dr. Elaine Wirrell, director of the Mayo Clinic's child epilepsy program.

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