FDA APPROVES EPIDOLEX®, A PURIFIED FORM OF CBD: HOW IS IT DIFFERENT FROM OTHER CBD PRODUCTS?

 

 

The last week of June, the U.S. Food and Drug Administration (FDA) approved Epidolex®, a cannabidiol (CBD) oral solution to treat seizures associated with epilepsy, including Lennox-Gastaut syndrome and Dravet syndrome, for patients two years of age and older. CBD is a chemical component of the Cannabis sativa plant, also known as marijuana. CBD does not cause intoxication or euphoria (a.k.a. the “high”) that comes from tetrahydrocannabinol (THC), which is the psychoactive substance in marijuana.

 

This is the first drug approved by the FDA that contains a purified substance derived from marijuana. FDA Commissioner Scott Gottleib, M.D. said “the FDA is committed to this kind of careful scientific research and drug development…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.” Dr. Gottleib went on to say “prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients.”1

 

Conversely, many unregulated CBD products are legal in a number of states, including Tennessee, even though they have not been approved by the FDA as safe or effective. Recently, 52 people were poisoned in Utah by an unregulated CBD product, causing an alert to be issued by both FDA and Centers for Disease Control and Prevention (CDC) warning people of the hazards of consuming unregulated products labeled as CBD.2

 

A comparison between Epidolex® and other CBD products shows significant variation. While doctors are legally allowed to prescribe Epidolex®, they are only allowed to recommend CBD products. Patients would purchase Epidolex® at a pharmacy and have specific dosing instructions whereas CBD is purchased through a dispensary without specific dosing instructions. Epidolex® is a purified extract of marijuana, containing 99% CBD and less than 1% THC: unregulated CBD products were found to be unpurified and contain up to 20% CBD. Many unregulated CBD products were found to contain THC and other contaminents.3

 

The FDA has previously approved Marinol® (approved in 1985), Cesamet® (approved in 1985), and Syndros® (approved in 2017), each formulations of THC which have been prescribed to treat nausea and vomiting associated with cancer chemotherapy and anorexia and weight-loss associated with AIDS.For more information on Epidolex®, visit https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf.

 

 

1 “FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy.” FDA News Release—June 25, 2018. DOI: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements /ucm611046.htm.
2 Horth RZ, Crouch B, Horowitz BZ, et al. Notes from the Field: Acute Poisonings from a Synthetic Cannabinoid Sold as Cannabidiol — Utah, 2017–2018. MMWR Morb Mortal Wkly Rep 2018;67:587–588. DOI: http://dx.doi.org/10.15585/mmwr.mm6720a5.
3 “The Marijuana Report.” National Families in Action. June 27, 2018.
4 “Pharmaceutical Products already exist; they are called Marinol & Cesament.” DEA Bulletin. DOI: https://www.dea.gov/divisions/sea/in_focus/marinol-cessmet.pdf.

 

 

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