The FDA Approves First CBD Product
On April 19th, a panel at the Food and Drug Administration voted to unanimously approve the first CBD product. This is a landmark success due to CBD’s relationship with cannabis.
The CBD product, Epidiolex, is made by GW Pharmaceuticals. Based in London, the company has been developing Epidiolex for the last few years. Epidiolex was created to specifically treat seizures due to Lennox-Gastaut and Dravet syndrome, which are variations of epilepsy.
The FDA allowed for an expedited timeline for the review of Epidiolex. On April 19th, GW Pharma presented 3 clinical studies to the panel, all of which took place over the course of 14-weeks. Now that Epidiolex has been given a ‘thumbs up’ by the panel, the FDA will decide on June 27th if the drug will receive final approval.
Physicians affiliated with Epidiolex have been diligent about differentiating from products found in a dispensary. One of these doctors is Dr. Orrin Devinsky, the director of NYU’s Langone Epilepsy Center. He’s been quoted saying:
This is not something you can get from a dispensary today in the United States. It’s not something that you can get by smoking marijuana. It is a very specific pharmaceutical grade product derived from marijuana, but quite different than what is available anywhere else right now in the United States.
Unfortunately, as successful as Epiodiolex has been in clinical trials, it’s approved medical use is relatively limited; Lennox-Gastaut and Dravet syndrome are both incredibly dilapidating conditions, however, research has shown that CBD has a much wider range of medical potential.
While this is a huge victory for the CBD and cannabis community overall, it does sting those who use CBD to alleviate many other conditions. Epiodiolex, if given final approval on June 27th, will be the first medication of it’s kind but limited in use. Luckily, individuals will still be able to find relief due to the availability of other pure and lab-tested CBD products.
How do you feel about this development? What would you like to see from the next FDA CBD product?