Nabiximols (Greenwich Biosciences, Carlsbad, CA) is approved for use as Sativex in over 25 countries, but not the US, for treatment of spasticity in multiple sclerosis (MS). Nabiximols is a chemically complex extract of the cannabis plant, consistently produced under controlled conditions and administered in consistent doses as an oral mucosal spray. Efficacy has been shown in multiple clinical trials. Post hoc analysis of clinical trial data, recently presented at the MSVirtual 2020 Meeting September 11-13, 2020, provides additional evidence of efficacy and tolerability as well as showing that nabiximols does not affect cognition or cause depression or suicidality.
After 4 weeks of treatment (Phase A), responders to nabiximols (n=266) had a mean 44% decrease on the spasticity numeric rating scale (NRS) vs 3% for nonresponders (n=366). Of the responders, 241 participants were randomly assigned to receive nabiximols (n=124) or placebo (n=117) for an additional 12 weeks (Phase B) and had, respectively a 46% vs 36% decrease in weekly mean NRS scores (P=.011) from the Phase A baseline. Those treated with nabiximols also had a 44% mean decrease in muscle spasm frequency compared with 24% of those treated with placebo (P=.006).
Post hoc analysis also showed there was no difference in symptoms of depression as measured by the Beck Depression Inventory-II (BDI-II) or suicidality for those treated with nabiximols vs placebo. There was no difference in cognition, as measured by the Paced Auditory Serial Addition Test (PASAT) in those treated with nabiximols (n=62) vs placebo (n=59) for up to 48 weeks.
“Concerns related to the mental health impact of unregulated cannabinoid therapies remain and this analysis sought to determine whether nabiximols had any such risks within the MS populations studied,” said Dr. John DeLuca, senior vice president for research, Kessler Foundation, and professor, Department of Physical Medicine & Rehabilitation and of Neurology, Rutgers New Jersey Medical School. “The results are promising and show that nabiximols, a well-studied cannabinoid therapy, did not increase the risk of cognitive impairment, depression, or suicide.”
Also presented at the VirtualMS 2020 meeting, a new survey by the North American Research Committee on Multiple Sclerosis (NARCOMS) shows that two-thirds of people with MS experience spasticity, pain, and sleep difficulties and that many use cannabis products to treat these symptoms. In this survey of over 3,000 individuals with MS, 20% reported current use of cannabis and approximately 12% reported previous use. Of those who used cannabis, 51% reported using it to treat spasticity, 44% for pain, and 38% for sleep.
Justin Gover, chief executive officer of Greenwich Pharmaceuticals said, "There is an unmet need for spasticity treatments for people with MS, who are finding their way to unregulated cannabis products. We know from addressing unmet needs in epilepsy that having an FDA-approved option provides a world of difference when seeking treatment. There is peace of mind that comes with a known safety profile, proven efficacy, and consistent dosing of a treatment you can get through a physician and have reimbursed by insurance. Patients with spasticity in MS deserve to have such an option and we remain committed to supporting the MS community as they look for relief from spasticity.”
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
James Geyer, MD, and Thomas Patton, MD