The first phase 3 clinical trial (NCT04203498) studying the cannabis-derived medicine nabiximols (Sativex; GW Pharmaceuticals, Carlsbad, CA) for spasticity in multiple sclerosis (MS) has been initiated. Previous European phase 3 clinical studies showed nabiximols was well-tolerated and provided reductions in participant-reported spasticity in the context of MS. Nabiximols is approved for use to treat MS spasticity in over 25 countries outside of the US but is still an investigational treatment within the US.
The study is a phase 3 double-blind parallel placebo-controlled study that will evaluate the safety and efficacy of nabiximols for spasm frequency over a 12-week period. Anticipated enrollment is 446 adults and the first participant has been screened and is in the baseline evaluation period.
“We are excited that the US phase 3 clinical program evaluating nabiximols in MS spasticity is now recruiting patients, after a delay due to COVID-19. Given the rigorous studies already conducted on the medicine outside of the US, 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 US,” stated Justin Gover, GW’s chief executive officer. “Now is the ideal time to develop nabiximols in the US as research shows a significant percentage of spasticity patients are today self-medicating using unapproved cannabis products to relieve their spasticity.”
“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 US,” said Dr. Stephen Krieger, associate professor of Neurology at the Mount Sinai Hospital. “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.”
Omar Bushara, BA; Rimas V. Lukas, MD; and Jessica W. Templer, MD
Adam M. Staffaroni, PhD; Elena Tsoy, PhD; Jack Taylor, BS; Adam L. Boxer, MD, PhD; and Katherine L. Possin, PhD
Carlos E.V. Sollero, MD; Hsin-Pin Lin, MD; Miguel Chuquilin, MD; James Wymer, MD; and Aaron M. Carlson, MD