Cannabis Extract Treatment for MS Spasticity, Sativex, Opens in US for Phase 3 Trial

A Phase 3 trial is in the works in the U.S. for Sativex (nabiximols), an oral spray that contains cannabis extracts, in treating spasticity — muscle stiffness or spasms — associated with multiple sclerosis (MS).

Sativex, by GW Pharmaceuticals, is available in 25 countries as an add-on therapy for MS patients with moderate-to-severe spasticity who fail to respond to other anti-spastic treatments. It contains cannabidiol (CBD) and tetrahydrocannabinol (THC), two of the most abundant cannabinoids found in the cannabis plant, according to a release.

Postive results have been reported from three previous European Phase 3 clinical studies. The results show nabiximols was well-tolerated and provided continued reductions in patient-reported spasticity for individuals with MS.

“We are excited that the U.S. Phase 3 clinical program evaluating nabiximols in Multiple Sclerosis spasticity is now recruiting patients, after a delay due to COVID-19," says Justin Gover, GW’s CEO, in the release. "Given the rigorous studies already conducted on the medicine outside of the U.S., and positive discussions with the FDA, we believe that we have a clear path to an NDA submission, potentially as soon as next year, and a significant second product opportunity for GW in the U.S. Now is the ideal time to develop nabiximols in the U.S. as research shows a significant percentage of spasticity patients are today self-medicating using unapproved cannabis products to relieve their spasticity.”

Stephen Krieger, MD, associate professor of neurology at the Mount Sinai Hospital, also says in the release "there is a significant need for new treatments to address spasticity in MS patients, a challenging condition with little therapeutic innovation in decades in the United States.”

“Nabiximols has the potential to be a rigorously tested and FDA-regulated cannabis-derived medicine for people living with MS. I look forward to participating as an investigator in this study which will evaluate the effect of nabiximols on the frequency of muscle spasms,” he adds.

The study will evaluate the safety and efficacy of nabiximols for spasm frequency over a 12-week period and is expected to enroll 446 participants. The first patient is now screened and in baseline evaluation where they will record their number of daily muscle spasms as they take their anti-spasticity medication.