On June 25th 2018, the US FDA approved the first medicine comprised of an active ingredient derived from marijuana: Epidiolex® (cannabidiol). Epidiolex® has been approved for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older.
Both of these conditions are rare forms of epilepsy that both begin in childhood, and while there are other medicines approved for Lennox-Gastaut syndrome, Epidiolex® is the first medicine approved to treat Dravet syndrome.
What were the approval of Epidiolex® based upon?
The approval of Epidiolex® (cannabidiol) was based on a Phase 3 clinical trial involving 516 patients. The trial results showed how Epidiolex® in combination with other antiepileptic therapies greatly reduced the number of seizures in patients with both conditions.
Some of the trial results, published in the New England Journal of Medicine, showed a 37.2 percent decrease in the monthly number of seizures for the 10mg solution, while for the 20mg solution, the percentage was 41.9 compared to placebo.
The approval was furthermore backed in April 2018 with 13-0 vote from the FDA advisory panel.
What is so special about the approval of Epidiolex® (cannabidiol)?
The short answer is the active ingredient. The active ingredient of Epidiolex® is called cannabidiol or simply CBD. Cannabidiol is a chemical component found in the cannabis sativa plant. Cannabidiol is not, however, the component that causes intoxication or euphoria – that is tetrahydrocannabinol or THC. This active ingredient makes Epidiolex® the very first medicine made from marijuana approved in the US.
While the societal debate about the use of marijuana for medical purposes is still running high, this new approval might make way for other companies and has at least shown the potential for other pharmaceutical companies developing new medicines with marijuana-components. It will be exciting to see what the future will bring for this market.
If you have any question regarding Epidiolex® (cannabidiol) or any questions in general, please contact us here
Epidiolex® is a registered trademark of GW Pharmaceuticals.