For those hoping that Big Pharma could still be blocked from the medical cannabis scene there is bad news: the deal is done. Big Pharma is knocking on cannabis’s door, looking for the first naturally-derived, Big Pharma-produced cannabis product to be on the market by the first half of 2016, perhaps even sooner.
Epidiolex is a liquid formulation of pure, plant-derived cannabidiol (CBD) manufactured by the British company, G.W. Pharmaceuticals. It is currently on the FDA Fast Track and has entered its final Phase 3 study for pediatric epilepsy disorders such as Dravet’s and Lennox-Gastaut’s syndromes with results scheduled for the first quarter of 2016.
Barring an unlikely catastrophic finding, there are plenty of signs that Epidiolex will breeze through this final stage and will thus have cleared the FDA’s testing requirements. For any other drug the remaining details would be purely administrative but Epidiolex is derived from cannabis and that puts a few more hurdles in the way before marketing can begin. There are, however, plenty of signs that government officials are literally paving the way for this new player.
Article Link: http://www.huffingtonpost.com/alice-oleary-randall/medical-cannabis-issue-th_b_7925956.html