For the first time ever, the U.S. Food and Drug Administration (FDA) has put its seal of approval on an oral cannabidiol (CBD) solution that will be prescribed to patients suffering from rare and severe cases of epilepsy. The actual list price of Epidiolex has not been set, but has been estimated at $2,500 to $5,000 a month, significantly more expensive than other CBD-based medication made available through state-legal medical cannabis programs. Where is weed legal? The drug reduced seizures by half in 40 percent of Dravet patients participating in the trials.
"This is clearly a breakthrough drug for an very bad disease", John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug.
A major milestone Monday for use of marijuana for treatment of health ailments.
Although marijuana remains illegal at the federal level, that hasn't stopped one drug company from bringing its cannabis-based seizure medicine to the American market.
Physicians say it's important to have a consistent, government-regulated version.
Dr. Anup Patel, neurology section chief at Nationwide Children's Hospital in Columbus, said Monday's announcement is good news for epilepsy patients who have been waiting for relief from the state's 2016 medical marijuana law or have been experimenting with unregulated products claiming to contain CBD.
Once the DEA gets the FDA recommendation for how CBD should be scheduled, it has 90 days to decide. Rescheduling cannabidiol paves the way for other advanced cannabinoid formulations, like the ones now being researched and developed by scientists on staff at my Colorado-based cannabinoid science business, ebbu.
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Shlomo Shinnar, president of the American Epilepsy Society and a neurologist at Montefiore Medical Center in NY, has said the drug will be "a very valuable addition" to the limited options for treating severe childhood-onset epilepsy.
Still, Jackson is glad that her family's experience could now provide new treatment options for other childhood seizure sufferers.
The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle. Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy. Shinnar said he will welcome approval of a medicine that had undergone stringent FDA review for safety and effectiveness.
This means the Drug Enforcement Administration (DEA) will have to reclassify it before GW can begin marketing Epidiolex.
The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the USA subsidiary of GW Pharmaceuticals.
Epidiolex was recommended for approval by an advisory committee in April, and the agency had until this week to make a decision. For instance, 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.
The FDA's first approval of a cannabis-derived compound happened thanks to sound science, and it must proceed that way.