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A drug made from a marijuana derivative has been approved for patients with certain forms of epilepsy.
Blaine Harrington III / Getty Images
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Blaine Harrington III / Getty Images
A drug made from a marijuana derivative has been approved for patients with certain forms of epilepsy.
Blaine Harrington III / Getty Images
The US Food and Drug Administration approved a marijuana derivative drug for the treatment of two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, which begin in childhood but may persist in adulthood.
The drug is made from purified cannabidiol, or CBD, a compound found in the cannabis plant. The drug will be marketed under the brand Epidiolex.
CBD has medicinal effects, but it does not result in the psychotropic effects of THC, the main psychoactive component of marijuana.
The FDA says it's the first drug approved in the United States that contains a purified substance derived from marijuana. The agency has already approved drugs made from synthetic versions of THC and other constituents of marijuana.
"This endorsement reminds us that promoting strong development programs that properly value the active ingredients in marijuana can lead to important medical therapies," said FDA Commissioner Scott Gottlieb, at a meeting today. an appeal to journalists.
Several states have legalized CBD oil specifically for the treatment of refractory epilepsy or seizure disorders. And, as reported by NPR, CBD supplements are widely available online and in dispensaries in the form of oils or tinctures. CBD oil has gained popularity among consumers as a cure for a variety of other ailments. However, the legal status of these products is uncertain, as is their quality. They are not regulated as pharmaceutical drugs, so the consistency and dosage can vary widely.
According to Robert Carson, pediatric neurologist at Vanderbilt University, who treats patients with epilepsy, the use of an FDA-approved pharmaceutical grade drug CBD will open a new route of treatment for epileptic patients by administering a constant dose of high quality.
"Our biggest concerns with craftsmanship [or supplement] The versions of CBD were related to consistency, "says Carson. We can not guarantee consistency. "
Carson says he's probably going to prescribe Epidiolex to go from the front. "I am always excited about the potential of a new therapy that has been well researched and has great potential for benefit," he says.
Several researchers are studying the potential of CBD to treat psychiatric disorders. For example, a clinical trial is underway to test whether CBD can be an effective treatment for people with post-traumatic stress disorder and alcohol use disorder. Another clinical trial will determine whether CBD could help prevent relapse among opioid users.
The approval of Epidiolex can help open the door to more CBD research because it helps to remove a regulatory hurdle. Until now, the Drug Enforcement Administration has classified CBD as a Schedule 1 substance. Like other drugs in this category, which include heroin and cocaine, these drugs are considered as having no medical use and presenting a high risk of abuse.
But now, with the approval of a CBD drug, the DEA will change that, according to Dr. Douglas Throckmorton, Deputy Director of Regulatory Programs at the FDA's Center for Evaluation and Drug Discovery. ,
"The DEA will have to make a different decision regarding the programming of the CBD … because it now has an accepted medical use," he said during a conference call with reporters.
He says the reclassification is underway now.
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