Health Care

GW Pharma's Epidiolex Becomes First Cannabis-Based FDA-Approved Drug (NASDAQ:GWPH)

GW Pharma's Epidiolex Becomes First Cannabis-Based FDA-Approved Drug (NASDAQ:GWPH)”

The Food and Drug Administration approved the medication from GW Pharmaceuticals on Monday to treat two rare forms of childhood epilepsy.

A new drug derived from marijuana just became the first of its kind to get the green light from the United States government. GW won't be able to market Epidiolex until the DEA reclassifies CBD.

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.

Epidiolex contains cannabidiol, one of the chemicals found in marijuana, however, it will not produce a high that is commonly seen in THC.

"This approval serves as a reminder that sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies", Gottlieb told reporters.

The drug, administered as an oil, could significantly improve the quality of life for patients with two types of childhood epilepsy: Dravet syndrome, a genetic illness that kills up to 20 percent of sufferers before age 20, and Lennox-Gastaut syndrome, a form that begins between ages 3 and 5 and causes intellectual disability. Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade CBD. The move could open the doors to other marijuana-derived medications as well as ease heavy restrictions on marijuana-related research. According to the agency's website, the FDA "is aware that there is considerable interest in [marijuana's] use to attempt to treat a number of medical conditions, including, for example, glaucoma, AIDS wasting syndrome, neuropathic pain, cancer, multiple sclerosis, chemotherapy-induced nausea, and certain seizure disorders".

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Justin Gover, chief executive officer of GW Pharmaceuticals, described the approval in the statement as "a historic milestone". In April, an expert advisory panel for the FDA voted unanimously to recommend Epidiolex's approval and determined that "CBD has a negligible abuse potential". That decision is expected within 90 days.

Another 20 states allow medical marijuana, but the USA government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.

Carson says he will likely prescribe Epidiolex going forward.

Patients are concerned that changes to state laws to allow for the first cannabis-derived medication in pharmacies could limit their access to cannabis medicine at dispensaries.

The drug should provide a more reliable alternative than the homemade cannabis oil parents for years have made for the children, said Devinsky, who once treated Vivian Wilson of Scotch Plains, a toddler with Dravet syndrome.

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



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