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Washington, DC — The Food and Drug Administration (FDA) has approved a drug that contains an active ingredient derived from the cannabis plant. The drug, Epidiolex, an oral solution containing cannabidiol (CBD), will be the first and only FDA-approved CBD drug on the market. The FDA has approved Epidiolex for use only in the treatment of two rare seizure disorders (Dravet Syndrome and Lennox-Gastaut Syndrome), and is the first FDA-approved treatment for patients suffering from Dravet syndrome. While there have been other medications that mimic the natural cannabinoids found in cannabis that have received FDA approval, Epidiolex is the first non-synthetic medication to be derived directly from the cannabis plant. The FDA’s approval of Epidiolex shows that it is possible to make medications from complex plant extracts.
Although 85% of Americans live in states with state-approved medical cannabis programs, the medicine provided by these programs is not federally approved, which means doctors cannot prescribe it (only recommend), insurance will not cover it, and patients must buy it from dispensaries or grow their own. However, because Epidiolex is FDA-approved, this means that it can be prescribed by doctors, purchased in pharmacies, and likely will be covered by insurance.
It is important to recognize that this medication will only be available to help a small percentage of the population; Dravet Syndrome affects 1:15,700 infants born in the U.S and Lennox-Gastaut has an annual incidence in children of 2 per 100,000. However, there are many other patients that currently rely on other cannabinoids such as THC, and whole plant cannabis-based medicines to treat their symptoms.
“FDA approval of other cannabis derived medicines could help expand access to patients that couldn’t otherwise afford it as well as help more doctors feel comfortable prescribing it to their patients knowing that patients will receive a safe, standardized dosage of medicine.” said Steph Sherer, Founder and President of Americans for Safe Access. “Until this medicine is made available and affordable to all who need it, ASA will continue to address the needs of medical cannabis patients.”
Despite the approval of Epidiolex, CBD remains a Schedule I substance and all other CBD products remain federally illegal. To be prescribed by doctors, Epidiolex will need to be placed in a Schedule other than I, because the other schedules by definition, recognize medical potential of a substance, while Schedule I does not. Scheduling of Epidiolex will be determined at a later date.
ASA applauds the FDA and their approval of the cannabis-based medicine Epidiolex. This cannabis extract approval could open a pathway for more appropriate scheduling of cannabis and cannabinoids but also opportunity for policy makers, regulators, and the medical cannabis industry to take steps to close the gap between FDA approval and expectations for products produced in medical cannabis programs. While federal laws make pre-clinical and clinical trials a challenge, under most medical cannabis programs, the industry can standardize their products and ensure that they are safe from contaminants.