On June 25, 2018 the FDA issued a press release announcing their approval of the first drug made from cannabis approved for use in the U.S.: Epidiolex®. The drug will be manufactured by Greenwich Biosciences, a subsidiary of GW Pharmaceuticals.
Epidiolex® has been approved for the treatment of two very rare but devastating forms of childhood epilepsy: Lennox-Gastaut syndrome and Dravet syndrome in patients that are two years or older.
The move is great news for parents of children with these disorders, some of whom have been using CBD oil to treat their children for years. This, despite facing legal consequences, in some cases as serious as losing custody of their children to the state.
The active ingredient in Epidiolex is cannabidiol. Currently it is classified as a schedule I drug at the federal level because it is derived from cannabis. The DEA will have to reschedule CBD in order for the drug to become available to patients in desperate need of this treatment.
Greenwich Biosciences has released a public statement stating that the drug is expected to be rescheduled and available to patients by prescription by fall of 2018. Rescheduling cannabidiol may have significant consequences for the CBD industry, the full effects of which are hard to predict.
More CBD Pharmaceuticals in the Pipeline
GQ Pharmaceuticals markets itself as the world leader in developing pharmaceuticals derived from cannabis.
In fact, they have already been approved in several countries outside of the U.S. for Sativex®. This drug contains both THC and CBD and is being used to successfully treat spasticity (uncontrollable muscle tightening), neuropathic pain and bladder control in patients with Multiple Sclerosis.
The FDA has not yet approved Sativex® for use in the United States. Other cannabis based drugs in development at GW Pharmaceuticals include those that may one day have treatment value for patients with autism, glioblastoma (a form of brain cancer), and schizophrenia.
FDA Warns Manufacturers of CBD Oil
Contained in the official announcement for the approval of Epidiolex, the FDA also issued a warning to manufacturers of CBD oil:
… we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.
The FDA has emphasized the importance of government regulated pharmaceuticals to ensure quality, dosing, and physician directed medical use. In fact, such warnings have been issued directly to some manufactures of CBD as early as 2017.
At CBD Oil Geek, I agree that it is irresponsible for manufacturers to claim their products cure cancer or treat serious medical conditions. The cannabinoids from the hemp plant are not fully understood, and even those doing cutting edge research are in the beginning stages of learning how these compounds operate with the endocannabinoid system in the human body.
When I conduct research for my product and company reviews, I always let my readers know if a CBD oil manufacturer makes unsubstantiated medical claims promising cures for serious medical conditions. It’s a red flag for sure!
Want to stay tuned to the latest CBS related news? Be sure to sign up for my newsletter.
Have something to say about the FDA approval of Epidiolex? Please leave a comment below to get a conversation started.