GW Pharmaceuticals (GWPH) announced today that it is starting up its phase 3 trial for nabiximols, an oral spray for patients who have spasticity associated with multiple sclerosis (MS). Nabiximols is a botanical medicine derived from cannabis plants. The drug, sold as Sativex outside the U.S., has already been approved in over 25 countries around the world for this indication, including in the U.K. and Canada.
In a press release, CEO Justin Gover said that he sees "a clear path to [a New Drug Application] submission, potentially as soon as next year, and a significant second product opportunity for GW in the U.S." Two years ago, GW saw its first cannabis-derived drug, Epidiolex, approved for use in the U.S. for patients who have rare forms of epilepsy. The Food and Drug Administration has recently expanded its approval for that drug.
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MS is a progressive neurological disease estimated to affect 2.3 million people worldwide. At least 400,000 Americans have MS, and roughly 320,000 of them have some form of spasticity, which involves painful muscle stiffness or involuntary muscle spasms.
Nabiximols is made up of CBD and THC, the active ingredient in marijuana that gives users a high. "Now is the ideal time to develop nabiximols in the U.S.," Gover said, "as research shows a significant percentage of spasticity patients are today self-medicating using unapproved cannabis products to relieve their spasticity."
GW shareholders have seen the value of their stock go up over 1,000% since the company's IPO in 2013. The stock was up almost 21% in early trading on Tuesday.
