Maker of First FDA-Approved Cannabis Drug Updates Roll-out Plans
GW Pharmaceuticals, the manufacturer of CBD drug Epidiolex, is making plans to bring its THC drug Sativex to the United States, pending regulatory approval. Epidiolex became the first medicine derived directly from cannabis to be approved by the FDA.
Sativex is an oral spray medication with 1:1 ratio of THC to CBD. GW Pharmaceuticals, a UK firm, first received approval for Sativex in the United Kingdom in 2010 as a treatment for spasticity caused by multiple sclerosis. Currently, the drug is approved for use in more than 30 countries worldwide to treat symptoms of multiple sclerosis and pain. But until now, the company has “never engaged with the FDA to get it approved in the US,” GW CEO Justin Gover recently told Business Insider.
“We now plan to meet with the FDA and determine a path forward,” he added.
Because Sativex has already been used successfully by patients around the world, approval in the US presents “a very late-stage opportunity for which we’ve generated a lot of data,” Gover said. “And it has a lot of potential, both for MS and neuropathic pain and potentially for other neurological conditions as well.”
Sativex Already Approved in 30 Countries
Although GW is just beginning the