FDA’s approval of new cannabis-based drug will pave the way for similar meds, says CEO

FAN Editor

Justin Gover, the CEO of GW Pharmaceuticals, told CNBC his company’s new drug will pave the way for other medications derived from marijuana.

On Monday, the Food and Drug Administration approved the company’s new epilepsy drug, Epidiolex, the first cannabis-based drug the U.S. regulator has approved.

“This is an approval, not just a landmark for Epidiolex and for patients who may benefit from this specific medication, but also a strong belief from this company that cannabinoids have a bright future in the form of other drug candidates derived from the cannabis plant across a range of other disease areas,” Gover said Tuesday on “Power Lunch.”

The medication is made from cannabidiol (CBD), one of hundreds of molecules found in marijuana plants. However, it is not known to produce a high. In fact, the drug concoction contains less than 0.1 percent of tetrahydrocannabinol (THC), the substance that induces a high.

Epidiolex has been developed to treat seizures in people 2 years and older with Dravet Syndrome and Lennox-Gastaut Syndrome, two rare forms of epilepsy that begin in childhood. Both diseases have high rates of mortality and few alternative options for treatment.

Gover said GW has been conducting research on cannabinoids, a group of closely related compounds that include cannabinol and the active constituents of cannabis, for about 10 years. The company is continuing to do research on other cannabinoid drug candidates in a range of disease areas, particularly within neurology.

However, since the U.S. government classifies marijuana as a Schedule 1 substance, meaning it has high potential for abuse, the medicine must also be approved by the Drug Enforcement Administration.

The DEA is evaluating the drug to determine if it has medical properties appropriate for selling. The DEA has 90 days to complete this process, Gover said.

The CEO said he doesn’t anticipate any delays and that GW is planning to launch the medication as early as this fall. No price has been set for the drug.

Cowen analysts said if Epidiolex is approved, sales could reach $1.3 billion annually by 2022.

— Reuters contributed to this report.

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