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America Has Its First FDA-Approved Cannabis Medicine

By David Jenison on June 25, 2018

Cannabis history was made in the U.S. today. 

The Food and Drug Administration (FDA) officially approved the use of EPIDIOLEX, creating the first federally legal medication made with a component of psychoactive cannabis, in this case cannabidiol (CBD). The GW Pharmaceuticals-produced drug treats seizures associated with two rare forms of pediatric epilepsy that tend to resist traditional forms of treatment: Lennox-Gastaut syndrome and Dravet syndrome. According to briefing documents released earlier this year, the FDA found no safety risks.

In a statement, GW's Chief Executive Justin Gover said, "Today’s approval of EPIDIOLEX is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies. This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care."

"This is an important medical advance," added FDA Commissioner Scott Gottlieb in a statement. "But it's also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use."

Some in the cannabis community fear the approval of EPIDIOLEX will benefit GW Pharmaceuticals but not the overall effort to legalize CBD, especially if the company lobbies against legalization efforts that could hurt its profit potential. Nevertheless, activists certainly hope the approval will affect some sort of change in the drug schedules

In December 2016, the Drug Enforcement Administration (DEA) made it clear that CBD remains a fully prohibited Schedule I drug whether it's derived from hemp or psychoactive cannabis, and in a more recent DEA report, the FDA continued its support for fully prohibiting cannabis and CBD as drugs with no medical value. However, a reporter spoke with a DEA spokeswoman who said the agency would "absolutely" reschedule CBD if the FDA approves EPIDIOLEX, adding "There's no ifs, ands, or buts about it." 

The truth is, the DEA should have rescheduled it already based on all the clinical findings, including these three recent studies that reaffirm the efficacy of cannabis-based epilepsy treatment. 

The Journal of Neurology, Neurosurgery, and Psychiatry published a study that examined "cannabinoids as adjunctive treatments for treatment-resistant epilepsy" utilizing data from six controlled trials and 30 observational studies. In 17 of the studies, nearly half of the patients with treatment-resistant epilepsy saw their seizures cut by more than half, and 8.5 percent of the patients across eight studies stopped experiencing seizures altogether after adding CBD to their care. 

Epilepsy Currents published the awesomely titled "Reefer to the Rescue" that found "cannabidiol (CBD) effectively reduced seizures and autistic-like social deficits in a well-validated mouse genetic model of Dravet syndrome…. The duration and severity of thermally induced seizures and the frequency of spontaneous seizures were substantially decreased. Treatment with lower doses of CBD also improved autistic-like social interaction deficits in DS mice."

Finally, a New England Journal of Medicine study conducted a double-blind, placebo-controlled trial with 225 Lennox–Gastaut syndrome patients at 30 clinical centers. GW Pharmaceuticals funded the study, it should be noted, the researchers found that patients given CBD experienced significant seizure reductions: 42 percent for patients treated with 20mg and 37 percent for those given 10mg, compared to 17 percent in the placebo group. 

The approval of EPIDIOLEX puts pressure on the agency to change the schedule status of CBD and hopefully for cannabis as well. 

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