- GW Pharmaceuticals and its subsidiary Greenwich Biosciences have launched Epidiolex, the first FDA-approved drug derived from cannabis, in the U.S. for the treatment of two rare childhood-onset epilepsy diseases.
- The launch comes after Epidiolex gained FDA approval in June and a several month wait for rescheduling by the Drug Enforcement Administration from Schedule 1 to Schedule 5. Epidiolex is now marketed for Lennox-Gastaut syndrome and Dravet syndrome in patients aged two years and older.
- The launch pushed up the U.K. company's share price by over 7%, and also boosted a rival pharma, Zogenix, which has a cannabis drug in late stage development.
Epidiolex is the first prescription pharmaceutical formulation of highly purified, plant-derived cannabidiol, also known as CBD.
The absence of the psychoactive ingredient tetrahydrocannabinol means that the drug doesn't have the high typically associated with cannabis use.
Its launch puts GW Pharmaceuticals ahead of rival Zogenix, which plans to submit a New Drug Application for ZX008 (fenfluramine) in the fourth quarter of 2018. Fenfluramine was originally developed as a diet drug, but cardiovascular safety concerns led to the drug being pulled from market.
Epidiolex provides an option for two hard-to-treat forms of childhood-onset epilepsy, which can continue into adulthood and have a long term impact on health.
"Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures," GW Pharmaceuticals CEO Justin Gover said in a statement.
The next challenge for the company will be to build a market for the drug. Lennox-Gastaut syndrome affects somewhere roughly 40,000 to 50,000 children and adults in the U.S., and Dravet syndrome is seen in one in 15,700 people across the U.S. population.
In order to reach these individuals, GW's subsidiary Greenwich Biosciences has put launch preparations in place, including a sales organization of two national directors, eight regional managers and 66 neurology account managers.
GW is also working with U.S. payers, and cementing a supply chain that will distribute the drug through five specialty pharmacy providers through a closed distribution network.
The tallest hurdle, however, may not be education and distribution, but rather the drug's cost.
At $32,500 a year, the drug's price is steep even with a program in place to lower out-of-pocket costs or provide free product to eligible patients.