Medical marijuana has been used to treat epilepsy in patients for years, but so far, it’s efficacy and safety hasn’t been supported by a regulatory green light from the Food and Drug Administration (FDA). Based on recently reported results for Epidiolex, a cannabidiol epilepsy medicine, that could be about to change.
Updated trial results released last month show that Epidiolex helps patients with rare epilepsy on its own, and treatment results may improve with long-term use. That news caused shares of Epidiolex’s drug developer, GW Pharmaceuticals (NASDAQ:GWPH), to jump 15.3% in November, according to S&P Global Market Intelligence.
After demonstrating that Epidiolex can reduce the rate of monthly seizures by around 40%, GW Pharmaceuticals recently filed Epidiolex for FDA approval in Dravet syndrome and Lennox-Gastaut syndrome, two rare forms of pediatric-onset epilepsy.
In November, the medical-marijuana company strengthened the likelihood of an FDA green light by unveiling additional trial results showing that 35% of Lennox-Gastaut syndrome patients responded to Epidiolex monotherapy, but only 13% of patients responded to a placebo. There has been some debate over how much of Epidiolex’s efficacy was tied to its use alongside clobazom, a common epilepsy medicine, and the risk of drug interactions, so the monotherapy data is important.
Results from Epidiolex’s long-term extension study also show that patient response to Epidiolex continues to be impressive. In Dravet syndrome patients, Epidiolex reduced total monthly seizures by 57% to 59% from baseline at week 60. In Lennox-Gastaut syndrome patients, it reduced monthly seizures by 62% to 70% from baseline at week 60.
GW Pharmaceuticals only markets one marijuana medicine currently, and sales of that drug, Sativex, are a rounding error. Therefore, an approval of Epidiolex in Dravet syndrome and Lennox-Gastaut syndrome is critical to improving this company’s financials.
There aren’t many patients