However, Epidiolex does not contain THC, the component of marijuana that gets people high, Jamie Alan, an assistant professor of pharmacology and toxicology at Michigan State University, tells Yahoo Lifestyle.
"The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients' quality of life", said Billy Dunn, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. She has not used Epidiolex in her own clinical practice and was not involved in the development of the drug but said she's not sure it will live up to "all of the hype" that has surrounded it.
He said the FDA would review legitimate applications for approval but said the agency needed solid scientific studies that demonstrate whether a product actually works and is safe.
"This is an important medical advance".
In 2013, the FDA gave GW Pharmaceuticals of the United Kingdom permission to use the cannabidiol-derived drug, in clinical trials. The company is also looking beyond CBD at uses for marijuana compounds that range from neurological conditions to diseases like multiple sclerosis and cancer to other issues like pain. The U.S. Food and Drug Administration approved Epidiolex, a cannabidiol oral solution for the treatment of seizures related to epilepsy. But six years ago, she started giving him oil, potent with CBD, made from a strain of marijuana grown in Teller County by the Stanley brothers.More news: Sara Netanyahu, Israeli Prime Minister's Wife, Is Charged With Fraud
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CBD is considered a Schedule I substance under the Controlled Substances Act because it's a chemical component of marijuana, placing it alongside drugs like heroin and MDMA. The floodgate effect is known as "sea change", as described by Barbara Carreno, public affairs officer for the U.S. Drug Enforcement Administration (DEA).
An estimated 30,000 children and adults suffer from Lennox-Gastaut syndrome, and fewer from Dravet syndrome. The British drugmaker studied the drug in more than 500 patients with hard-to-treat seizures, overcoming numerous legal hurdles to conducting research with cannabis.
And Epidiolex's approval doesn't mean other CBD substances are OK to sell, Gottlieb said.
The European Medicines Agency is now reviewing Epidiolex for treating seizures associated with LGS and Dravet Syndrome, with a decision on whether or not to recommend approval expected early next year.
USA health regulators have approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law. But GW said it expects that the DEA will reschedule CBD within 90 days. And the company plans to continue importing the medicine, bypassing onerous USA regulations on manufacturing restricted substances.
Treatments available for both disorders are far from flawless and some patients resort to buying "self-prescribed" CBD online or from unregulated vendor sites, Dr. Pavel Klein, founder of the Mid-Atlantic Epilepsy and Sleep Center, said.