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First FDA Approved Cannabis-based Drug - EPIDIOLEX

July, 2018

The US Food and Drug Administration (FDA) has approved the use of the first cannabis-based drug - Epidiolex, legalizing in the United States. Epidiolex is an oral drug, which is developed by GW Research Ltd., will be used to treat Lennox-Gastaut syndrome - one form of epilepsy - in patients over the age of two. In addition to being the first cannabis-based drug to be approved in the US, Epidiolex is now the first FDA-approved drug to treat Dravet syndrome too.

Epidiolex is a syrup-like medicine, which contains an active ingredient from weed called CBD, or cannabidiol. CBD has been credited with an array of medical benefits, from treating autism and anxiety to depression and cancer, but many of these claims remain unsupported by evidence. Recent data, however, suggests it’s effective for treating seizures, including Dravet syndrome and Lennox-Gastaut syndrome. In the case of Epidiolex, the drug’s efficacy was studied in three clinical trials involving 516 patients. Taken along with other medications, Epidiolex was shown to be effective in reducing the frequency of seizures when compared to placebo.

However, CBD is still considered a Schedule I substance in the US under the Controlled Substances Act. According to the Drug Enforcement Administration (DEA), Schedule I drugs are substances or chemicals defined as “drugs with no currently accepted medical use and a high potential for abuse,” a classification that includes drugs such as heroin, LSD, and ecstasy. Hence, despite the FDA’s go-ahead, Epidiolex won’t be available to patients until CBD is rescheduled by the DEA, which is expected to happen within few months.

“Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients.” - Scott Gottlieb, FDA Commissioner.

– Victor Mukherjee
Assitant Manager (Healthcare Market Research)
Infoholic Research