Data from 3 European randomized placebo-controlled clinical trials of nabiximols (Sativex; GW Pharmaceuticals, Carlsbad, CA) for spasticity in multiple sclerosis (MS) were presented at the American Academy of Physical Medicine and Rehabilitation (AAPMR) Annual Assembley. Nabiximols is derived from extracts of the Cannabis plant.
The analysis included data from 184 participants in the GWMS0106 study, 241 participants in the GWSP0604 study, and 106 participants in the SAVANT study. Spasticity was evaluated using the Numerical Rating Scale (NRS) in all 3 trials. Muscle strength was tested with the Motricity Index (MI) in GWMS0106 and GWSP0604; and mobility was evaluated with the timed 10-Meter Walk Test (10MWT) in GWSP0604 and SAVANT.
Treatment with nabiximols significantly improved mean NRS spasticity score vs placebo in the GWMS0106 and GWSP0604 studies (-0.52 points; P=.048 and -0.84 points; P=.0002, respectively) without significantly affecting the MI for legs (3.86, P=.054 and -3.34, P =0.069, respectively).
The 10MWT scores were not affected significantly by nabiximols treatment in any of the 3 trials.
Justin Gover, CEO, GW Pharmaceuticals said “These studies, which served as the basis for nabiximols regulatory approvals outside the US, provide important insights into the potential of nabiximols for people with MS-related spasticity. We are now recruiting participants for the first nabiximols Phase 3 clinical trial in the US in pursuit of our goal of bringing to market the first FDA-approved medicine derived from the whole cannabis plant for the treatment of spasticity in MS.”
Ganesh M. Babulal, PhD, OTD, and Catherine M. Roe, PhD
Henrik Zetterberg, MD, PhD; Deborah O.T. Alawode, BSc; Ashvini Keshavan, MRCP, PhD; Antoinette O’Connor, MRCPI; Philip S. J. Weston, MRCP, PhD; Ross W. Paterson, MRCP, PhD; Amanda Heslegrave, PhD; Nick C. Fox, MD, FRCP, FMedSci; Michael P. Lunn, FRCP, PhD; and Jonathan M. Schott, MD, FRCP
Cyrus A. Raji, MD, PhD; Somayeh Meysami, MD; and Mario F. Mendez, MD, PhD