Could Epidiolex Launch In 2017?

GW Pharmaceuticals (NASDAQ: GWPH) presented three studies at the American Epilepsy Society’s 69th Annual Meeting in Philadelphia that highlight the safety and effectiveness of its cannabidiol-based drug, Epidiolex. Some analysts predict FDA approval as early as 2017.

If approved, Epidiolex might offer another treatment option for parents of children with treatment-resistant forms of epilepsy, such as Lennox-Gastaut Syndrome and Dravet Syndrome. The larger political implications Big Pharma’s entrance into the world of medical cannabis are somewhat more mixed, however.

Since its founding in 1998, GW Pharma has focused on discovering, developing and commercializing therapeutic drugs from specially-bred cannabis plants. Its high-THC drug, Sativex, used in the treatment of muscle spasms associated with multiple sclerosis, has been approved for use in 28 countries and fast-tracked for FDA approval in the United States.

Epidiolex, a high-CBD drug was approved for an expanded access Investigational New Drug program. Of the 261 patients who were the subjects of the most recent studies, nearly half saw a reduction in total seizures of greater than or equal to 50 percent after 12 weeks of treatment. GW has announced that it expects to have results from larger Phase 3 safety and efficacy studies during the first half of 2016.

GW Pharma has long positioned itself as a regular pharmaceutical company that coincidentally uses compounds derived from the cannabis plant. It has opposed full legalization because of the potential for negative impact on its share price, even going so far as to hire a high-profile marijuana critic to help it distinguish its products from medical marijuana. The profitability of drugs like Epidiolex and Sativex depends, quite directly, on the continued federal barriers to medical marijuana research in this country as well as the continued illegality of cannabis use under federal law.