Medical

U.S. okays marijuana-based drug for seizures

U.S. okays marijuana-based drug for seizures

Having an FDA-approved, pharmaceutical-grade CBD drug will open up a new treatment option for epilepsy patients by delivering a high-quality, consistent dose of CBD, says Robert Carson a pediatric neurologist at Vanderbilt University who treats patients with epilepsy.

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. Like other drugs in this category, which include heroin and cocaine, these drugs are considered to have no medical use and a high potential for abuse.

GW Pharma won't be able to launch the drug right away, however, because its active ingredient, CBD, needs to be rescheduled by the DEA.

A government-regulated version of the oil will ease some doubts about the amount of CBD in the product, which can vary based on its origin, said Dr. Elaine Wirrell, director of the Mayo Clinic's child epilepsy program.

On a call with reporters on Monday, FDA Commissioner Scott Gottlieb, M.D., cautioned that Epidiolex's green light is not an approval for marijuana but an approval for "one specific CBD medication for a specific use" based on well-controlled clinical trials.

Cannabidiol is derived from the cannabis plant, also known as marijuana.

"This is clearly a breakthrough drug for an 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.




There are side effects, the most common being sleepiness, Gover said.

Why? Because their product and company status will no longer exist in the legal gray area, and hopefully the mass confusion over which CBD products are legal and which are not will come to an end.

Dravet syndrome is a rare genetic condition that causes frequent fever-related seizures, involuntary muscle spasms and a potentially life-threatening state of continuous seizure activity requiring emergency medical care. On the other hand, CBD derived from cannabis is a schedule I drug, and only 28 states and Washington, DC have so far legalized it; 15 states have only legalized CBD by itself.

"Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", he said.

A GW Pharmaceuticals spokeswoman said the company would not immediately announce a price for the drug, which it expects to launch in the fall. The FDA is willing to help companies that want to pursue such research programs, he said, but they need to prove their products work and are safe with data from clinical trials.

It's not clear how quickly the drug will be available for prescription. A year ago a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health.

Prior to the FDA decision, a press officer for the DEA confirmed to Leafly that the FDA decision will prompt action from the DEA.


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