Following the keenly anticipated June approval of its cannabis-derived Epidiolex, GW Pharmaceuticals $GWPH has finally launched the rare epilepsy drug in the United States.
The drug comprises cannabidiol (CBD) with a minuscule 0.1% of tetrahydrocannabinol (THC), the component renowned for its ability to get people high. Epidiolex is sourced from natural cannabis grown by the British drugmaker in the United Kingdom. In America, marijuana is strictly controlled on the federal level in the same schedule LSD and heroin is. Therefore, even though Epidiolex won FDA approval in June for two forms of childhood epilepsy — Lennox-Gastaut syndrome and Dravet syndrome — GW had to get the drug rescheduled to a lower category before it could be launched for sale. Most patients that suffer from these disorders require a host of seizure medications, and a majority are resistant to existing anti-epileptic therapies.
GW has set a list price of $1,235 per 100 ml bottle for the oral seizure treatment, GW spokesperson Stephen Schultz told Endpoints News. “Based on anticipated dosing and patient weight assumptions, we believe that this translates to a weighted average gross price in the first year of $32,500, which is in line with other branded anti-epileptic drugs used to treat these conditions,” he said, adding that this pricing approach had received support from the payor community and that the company was developing a patient support program that could lower patients’ out-of-pocket costs, or provide the product for free to eligible patients.
Epidiolex is also currently being evaluated for other epilepsy conditions, including tuberous sclerosis complex. Founded in 1998, GW is also the maker of the world’s first cannabis-plant derived prescription medicine, Sativex, which it has long sold in Europe and other territories outside the United States for the treatment of spasticity due to multiple sclerosis. GW is planning to test Sativex in a phase III trial in the United States.