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The Cost of FDA-Approved CBD

The Cost of FDA-Approved CBD

As CBD Journal reported back in June, the FDA has approved the use of a CBD-based drug called Epidiolex for the treatment of two of the hardest-to-treat forms of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome. According to a story in the New York Times, makers of the drug, British-based GW Pharmaceuticals, says the drug will cost roughly $32,500 per year. A spokesperson for the company said the price was based on feedback from insurance companies and is in line with the cost of other epilepsy drugs.

Although the figure seems quite high at first glance, it is actually on the lower end of what analysts projected the drug would cost back in 2016. At that time it was estimated that the price of Epidiolex, the first drug based on phytocannabinoids to be approved by the FDA, might range from between $30,000 to $60,000 per year according to the Times.

A Green Light From The FDA

The FDA gave the drug the green light as a result of three large clinical trials in which researchers presented strong evidence that the medicine significantly curbs some of the worst symptoms of Lennox-Gastaut syndrome and Dravet syndrome. In one such study, published in the New England Journal of Medicine in May, patients continued to take their conventional anti-seizure medications, many of which are ineffective at controlling all the seizures but also took either a 10mg or 20mg dose of Epidiolex.

Results showed that patients using the drug experienced fewer epileptic seizures. At the end of the 28-day trial, patients had reported a 42 percent reduction in seizures. By comparison, the placebo group experienced a 17 percent drop.

Before doctors are allowed to prescribe Epidiolex to their patients, it’s main ingredient, CBD, must be rescheduled by the Drug Enforcement Administration (DEA). Back in early July, DEA public affairs representative Barbara Carreno claimed that the agency had 90 days to drop CBD down to a Schedule II or III drug. And, according to Forbes, the change is already in progress. "We don't have a choice on that," DEA public affairs officer Barbara Carreno told Business Insider in June. "It absolutely has to become Schedule 2, 3, 4, or 5."

Medical Cannabis Proponents Are Hopeful

Proponents of medical cannabis are hopeful that the approval will unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds. However, given the high cost, patients whose treatment is not covered by insurance will likely turn to less expensive sources of CBD.

Gangolli says that once patients do obtain prescriptions, the expected wait time to receive the medication will be, on average, three weeks.