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U.S. Health regulators approved Monday the first marijuana-based prescription drug, a step that could further stimulate research on a drug that remains illegal under federal law, despite increasing legalization for recreational use and medical.
approved the drug, called Epidiolex, to treat two rare forms of epilepsy that begin in childhood. But it's not quite medical marijuana.
Strawberry flavored syrup is a purified form of a chemical ingredient found in the cannabis plant – but not the one that attracts users. It is not yet known why the ingredient, called cannabidiol, or CBD, reduces seizures in some people with epilepsy.
British pharmacist GW Pharmaceuticals has studied the drug in more than 500 children and adults with epileptic seizures that are difficult to treat. Barriers that have long hindered cannabis research
FDA officials said the drug reduced seizures when it was badociated with older antiepileptic drugs. "19659003" "It represents a new Devinsky chapter, from NYU Langone Health's comprehensive epilepsy center, told CBS News." Many of these children and young adults have had significant reductions in their most severe crises and "
The FDA has already approved synthetic versions of another medicinal ingredient for cannabis, including severe weight loss in HIV-positive patients." Epidiolex is essentially a pharmaceutical-grade CBD oil, that some parents already use to treat children with epilepsy.CBD is one of the over 100 chemicals found in marijuana.But it does not contain THC, the ingredient that gives to marijuana its psychotropic effect.
Doctors say that it is important to have a consistent version, regulated by the government.
"I am really happy that we have a product q "It will be much cleaner and one that I know what it is," said Dr. Ellaine Wirrell, program director of the Mayo Clinic for Infantile Epilepsy. "In artisbad products, the doses often vary from one bottle to the next, depending on where you get it."
Side effects of the drug include diarrhea, vomiting, fatigue and sleep problems.
Allison Ms. Hendershot considered relocating her family to Colorado, one of the first states to legalize marijuana and to house a large network of CBD producers and suppliers. His 13-year-old daughter, Molly, has suffered severe seizures since the age of 4 months. But Hendershot has learned of the existence of an Epidiolex trial at New York University.
"I preferred this to some of these other options because it's a commercial product that has undergone rigorous testing," says Hendershot, who lives in Rochester. York
Since she's been given Epidiolex, Hendershot says her daughter was able to concentrate more and that she had fewer "falling" fits – in which her whole body becomes limp and collapse
. "The first three years of her life, I would say, were devastating, I did not know anything about crises, I did not know what life would look like," Natalie, Lili's mother. Gilmore, told CBS News
He got to the point where Lili, now 17, had hundreds of seizures a week. After her parents enrolled her at the Epidiolex trial at NYU, her conscience increased and seizures decreased.
"For us, any little relief we could have with the seizures is huge," said Natalie. is currently sold online and in specialty stores throughout the United States, although its legal status remains cloudy. Most growers say that their oil is made from hemp, a plant of the cannabis family that contains little THC and can be legally grown in several states for clothing, food and others. uses.
FDA Commissioner Scott Gottlieb suggested that the agency would review CBD products with "uncertain dosages and formulations".
"We are ready to act when we see the illegal marketing of products containing CBD
The FDA had already issued warnings to CBD producers who claimed that their products could treat specific diseases , such as cancer or Alzheimer's disease.Only products that have received official FDA approval can make such claims, generally requiring clinical trials costing millions.
Most CBD producers avoid the problem by only making general allegations about general health and well-being. "I do not know a mother or father in his good sense who will change what already works," said Heather Jackson, CEO of Realm of Caring, a charitable affiliate affiliated with Colorado-based CW Hemp, one of the country's largest CBD companies. "I really do not think it affects us will be a lot. "
Jackson's group estimates that the typical family using CBD to treat infantile epilepsy spends about $ 1,800 a year on the merits.
A spokeswoman for GW Pharmaceuticals not immediately announce a price for the drug, which he expects to launch in the fall. Wall Street badysts have already predicted that it could cost $ 25,000 a year, with annual sales eventually reaching $ 1 billion.
For their part, GW Pharmaceuticals executives say that they are not trying to disrupt the products already on the market. The company has pushed legislation in several states to make sure its drug can be legally sold and prescribed.
The FDA approval for Epidiolex is technically limited to patients with Dravet and Lennox-Gastaut syndromes, two rare forms of epilepsy for which some treatments. But doctors will be able to prescribe it for other uses
The new drug enters an increasingly complex legal environment for marijuana.
Nine states and the District of Columbia have legalized marijuana for recreational purposes. Twenty other states allow medical marijuana, but the US government continues to clbadify it as a controlled substance without medical use, in the same category as heroin and LSD.
Despite growing acceptance, there is little rigorous research on the pros and cons of marijuana. Last year, a government-mandated group concluded that the lack of scientific information on marijuana and CBD was threatening public health.
Before starting sales of Epidiolex, the Drug Enforcement Administration must officially reclbadify CBD into a different category of drugs.
GW Pharmaceuticals manufactures the drug in the UK from cannabis plants specially bred to contain high levels of CBD. And the company plans to continue importing the drug, bypbading expensive US regulations on the manufacture of controlled substances.
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