GW Pharma set to enter Phase III trials of cannabis for multiple sclerosis

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The research into using cannabis to treat MS has been progressing for more than a year

There is new hope coming out of Europe showing positive results in the treatment of the spasticity associated with multiple sclerosis (MS) using a cannabis-based drug called Nabiximois, known outside the US as Sativex. Now a California-based company, GW Pharmaceuticals, is about to launch the first Phase III trial to study Nabiximois in the USA with the intention of manufacturing and marketing the treatment here in the country, which has already achieved approval in some 25 countries around the world.

Positive results from previous studies in Europe have shown that Nabiximois was “well-tolerated and provided continued reductions in patient-reported spasticity for individuals with MS,” according to a representative of GW Pharmaceuticals.

The CEO of GW Pharmaceuticals, Justin Gover, is excited about starting the Phase III studies in the US and says that he has had ‘positive discussions’ with the U.S. Food and Drug Administration and now believes his company has a clear path to the introduction of a New Drug Application as early as 2021. He said in a recent statement, “Now is the ideal time to develop Nabiximois in the U.S. as research shows a significant percentage of spasticity patients are self-medicating using unapproved cannabis products to relieve their spasticity.”

Nabiximois, which is administered as an oral spray, is formulated from extracts of the cannabis plant, which contain the principal cannabinoids THC and CBD as well as other minor constituents from the cannabis plant. It is also being tested on spinal cord injury spasticity. GW already has another FDA approved cannabis-based product on the market, Epidiolex, which is used in treatment for seizures associated with rare forms of epilepsy.