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.
An FDA advisory panel recommended the approval of Epidiolex last April, specifically for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, two serious and rare forms of epilepsy that appear at an early age.
An estimated 30,000 children and adults suffer from Lennox-Gastaut syndrome, and fewer from Dravet syndrome.
The drug, Epidiolex, is derived from cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant, and contains less than 0.1 percent of tetrahydrocannabinol (THC), the psychoactive component that makes people high.More news: Uruguay make their best start to a World Cup since 1954
"Sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies", FDA Commissioner Dr. Scott Gottlieb said in a statement released Monday by the agency.
Once the DEA gets the FDA recommendation for how CBD should be scheduled, it has 90 days to decide. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician's care.
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. Once the FDA approves the drug, expected by the end of June, doctors will be able to prescribe it legally.
A drug made from a derivative of marijuana has been approved for patients with certain forms of epilepsy. And Epidiolex could well be the first in a wave of marijuana-based therapies; agency officials said they have implemented regulatory processes to help drug developers test marijuana or its components in their own clinical trials. Patel said the drug trials generated good information about safety and side effects of CBD use, and the FDA approval opens doors for more research on the benefits and effectiveness of CBD on other conditions.
Gottlieb hinted at additional enforcement actions against companies that sell unregulated CBD products with medical claims that aren't backed up by evidence.More news: James Harden wins 2018 NBA MVP over Anthony Davis, LeBron James
That's according to Steve Fox, the director of VS Strategies, which was retained by GW Pharmaceuticals to assist with lobbying and public relations efforts.
Shauna Garris, a pharmacist, pharmacy clinical specialist and adjunct assistant professor at the University of North Carolina's Eshelman School of Pharmacy, said the drug is effective and works somewhere between "fairly" and "very well".
Epidiolex will be marketed by Greenwich Biosciences, a subsidiary of GW Pharmaceuticals.
A new drug derived from marijuana just became the first of its kind to get the green light from the U.S. government.More news: Harley, stung by tariffs, shifts some production overseas
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