FDA approves cannabis-derived medicine; DEA must weigh in

FDA approves cannabis-derived medicine; DEA must weigh in

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.

The U.S. Food and Drug Administration has approved a marijuana-deriveddrug for the treatment of two rare and serious forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, that begin in childhood but can persist in adulthood.

Following a successful trial in May that proved the drug reduced seizure frequency by 40 percent, Epidolex will become the first FDA-approved medicine to include cannabidiol, or CBD, a non-psychoactive chemical found in the marijuana plant. Where is weed legal? "Epidiolex has been studied and proven to significantly reduce seizures so, in a few short months, it will be a new and welcome product for doctors to consider for their patients in need".

A major milestone Monday for use of marijuana for treatment of health ailments. It's in phase 3 testing for a potential approval in the U.S. The company is also working on cannabinoid programs against glioblastoma, schizophrenia and more.

"For those living with intractable seizures caused by LGS and Dravet syndrome, Epidiolex represents a true medical advancement", said Philip Gattone, president and CEO of the Epilepsy Foundation.

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Nine states plus Washington, D.C., have legalized medical marijuana, and the FDA said even more are considering it, particularly after it approved Epidolex. Others said they are anxious to try an FDA-approved product. "However, it remains to be seen whether physicians will be comfortable prescribing this new agent to those patients who may benefit from it, and whether it will be priced in a range that patients may afford". The administration would then presumably reclassify cannabidiol in a less restrictive schedule (the DEA has five drug schedules, with Schedule I being the most restrictive and Schedule V being the least restrictive).

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.

Some experts believe the anticipated approval will likely open the floodgates for product demand of other CBD products, and place further pressure on the FDA to move it along and approve other CBD-based medications. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions. "I really don't think it's going to affect us much". GW Pharmaceuticals grows the plants in the United Kingdom. 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 agency is expected to do so within 90 days.

The European Medicines Agency is expected to rule on the therapy in early 2019.

The FDA's first approval of a cannabis-derived compound happened thanks to sound science, and it must proceed that way.