Greenwich Biosciences will be presenting its analysis regarding Nabiximol treatment at the American Academy of Physical Medicine and Rehabilitation (AAPM&R) Annual Assembly.
Greenwich Biosciences, U.S. subsidiary of GW Pharmaceutical (NASDAQ:GWPH), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, will present data from an analysis of three Phase 3 clinical trials of nabiximols in spasticity among persons with multiple sclerosis (MS) at the American Academy of Physical Medicine and Rehabilitation (AAPM&R) Virtual Annual Assembly.
The research will be presented live during the November 14 Research Spotlight session on Neurological Rehabilitation. The analysis showed that the statistically significant improvement in spasticity observed with nabiximols in all three trials was not accompanied by an increase in muscle weakness or decrease in preferred walking speed.
"Muscle weakness in MS is more than feeling weak; it represents genuine difficulty in moving and can make even daily activities like walking and dressing challenging," said the Director of Rehabilitation Services, The Mellen Center for Multiple Sclerosis Treatment and Research, The Cleveland Clinic Foundation, and a consultant to GW Pharmaceuticals Francois Bethoux.
We are encouraged that the data from these trials showed that nabiximols not only improved patient-reported spasticity but also did not appear to increase muscle weakness or negatively affect preferred walking speed."MD & GW Pharmaceuticals consultant, Francois Bethoux.
"Between 60 and 90 percent of people with multiple sclerosis report experiencing spasticity; and muscle weakness can be a serious side effect with current anti-spasticity medications," said Bethoux.
Data from three randomized, placebo-controlled trials of nabiximols (GWMS0106, GWSP0604, and SAVANT) conducted in Europe were analyzed to assess the relationship between measures of spasticity and muscle strength in lower extremities or walking speed. Spasticity was evaluated using the Numerical Rating Scale (NRS) in all three trials, muscle strength using Motricity Index (MI) in GWMS0106 and GWSP0604, and mobility using timed 10-Meter Walk Test (10MWT) in GWSP0604 and SAVANT. All three trials enrolled persons with MS-related spasticity inadequately managed by current medications.
- GWMS0106: Nabiximols significantly improved the mean NRS spasticity score vs. placebo (-0.52 points; p=0.048), without significantly affecting the MI for legs (3.86, p=0.054).
- GWSP0604: Nabiximols significantly improved mean NRS spasticity score from baseline vs. placebo (-0.84, p=0.0002), without significantly affecting the MI for legs (0.97, p=0.439) or the 10MWT results (-3.34, p=0.069).
- SAVANT: Nabiximols significantly improved mean NRS spasticity vs. placebo (-1.9, p<0.0001), without significantly affecting the 10MWT results (-1.71, p=0.11).
The analysis included data from 184 participants in GWMS0106, 241 participants in GWSP0604, and 106 participants in SAVANT.
Nabiximols is approved by regulatory bodies in 28 countries outside the United States to treat MS spasticity. GW recently initiated the first global Phase 3 clinical trial studying nabiximols for MS spasticity that will engage patients and investigators in the United States. The first trial is one of five new pivotal studies planned for nabiximols in MS spasticity globally, with the remaining studies on track to commence later in 2020 or in 2021.
"These studies, which served as the basis for nabiximols regulatory approvals outside the U.S., provide important insights into the potential of nabiximols for people with MS-related spasticity," said Justin Gover, GW's Chief Executive Officer. "We are now recruiting participants for the first nabiximols Phase 3 clinical trial in the U.S. 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."
To learn more about GW Pharmaceuticals visit the Company HQ here.
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