Nabiximols, known as Sativex outside of the U.S. and approved for use to treat MS spasticity in over 25 countries, is a complex botanical medicine formulated from extracts of the cannabis plant administered as an oral spray. Positive results from three previous European Phase 3 clinical studies show nabiximols was well-tolerated and provided continued reductions in patient-reported spasticity for individuals with MS.
This Phase 3 trial is one of five pivotal studies planned for nabiximols in MS spasticity, with the remaining studies on track to commence either later this year or in 2021. GW expects that a positive result in any one of these five studies will enable an NDA submission, potentially as early as mid- next year.
“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. 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.,” stated Justin Gover, GW’s Chief Executive Officer. “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.”
“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,” 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.”
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 and is expected to enroll 446 participants. The first patient is now screened and in baseline evaluation.
Beyond this initial study, the Company intends to commence the following additional Phase 3 trials of nabiximols for MS-associated spasticity:
- Phase 3 muscle tone studies – placebo-controlled cross-over design
- N=52; Expected start: Q4 2020 (subject to COVID)
- N=190; Expected start: Q1 2021
- N=36 (nabiximols responders); Expected start: Q1 2021
- Phase 3 spasm frequency studies – placebo-controlled parallel group
- N=~200 (nabiximols responders); Expected start: Q2 2021
Source: Company Press Release