Health Care

FDA approves cannabis-based drug for epilepsy

FDA approves cannabis-based drug for epilepsy

Right now in Texas under the Texas Compassionate Use Act, epilepsy patients are the only one allowed to get a prescription for CBD oils from three state-approved dispensaries.

In a statement accompanying Monday's approval announcement, the FDA hastened to note that it's not signing off on the safety or medical utility of marijuana in general ― just this one compound and only for this limited use.

Several researchers are studying the potential of CBD to treat psychiatric conditions.

Cannabis, including CBD, is a "schedule 1" drug, meaning it has no medicinal value and poses a high risk for abuse.

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In clinical trials, children with Dravet syndrome who took Epidiolex experienced 39 percent fewer seizures; those with Lennox-Gastaut syndrome saw a 37 percent decrease. Nevertheless, we're encouraged that the Epidiolex approval will bring more and more research interest and funding to cannabinoid based therapies that have the potential to provide significant changes to consumers' lives. 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.

Before sales of Epidiolex can begin, the Drug Enforcement Administration must formally reclassify CBD into a different category of drugs that have federal medical approval.

The FDA said Monday that the drug doesn't cause the high that comes from the chemical tetrahydrocannabinol, or THC, which is the main psychoactive component of marijuana.

The agency, he added, remains concerned about "the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims". While there are other drugs approved to treat Lennox-Gastaut, there had previously been none for Dravet.

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The goal is have it available in pharmacies by the end of the year, said Orrin Devinsky, a pediatric neurologist and director of the New York University-Langone and Saint Barnabas Comprehensive Epilepsy Center in Livingston, who co-authored the research.

An FDA advisory committee in April had recommended unanimously that Epidiolex be approved.

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. 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. Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy. "I really don't think [the FDA approval is] going to affect us much". GW Pharmaceuticals grows the plants in the United Kingdom. But GW said it expects that the DEA will reschedule CBD within 90 days. 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. "This is how sound medical science is advanced".

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