Abstract Details

Title Post Hoc Analysis of Nabiximols Efficacy by Concomitant Medication Use in 2 Enriched Placebo-Controlled Randomized Clinical Trials (RCTs)

Topic Neuro-rehabilitation

Presentation(s) P16 - Poster Session 16 (8:00 AM-9:00 AM)

Poster/Presentation
Number 7-002

Objective To assess treatment outcomes for people with multiple sclerosis (PwMS) spasticity taking nabiximols with or without concomitant antispasticity medications (ASMs), such as baclofen.

Background Spasticity, a common symptom of MS, is undertreated, and standard treatment options often fail to provide adequate control. Nabiximols, a cannabinoid oromucosal spray, improved spasticity in PwMS measured by a spasticity 0–10 numeric rating scale (NRS) in 2 placebo-controlled RCTs: SAVANT and GWSP0604.

Design/Methods SAVANT and GWSP0604 used a single-blind lead-in Part A followed by randomization of eligible participants in Part B. In SAVANT only, patients were allowed to optimize the dose of their ASM(s). Participants reported Spasticity NRS score and spasm frequency daily. Mean 7-day average daily Spasticity NRS score and mean 28-day average daily spasm frequency were assessed. The treatment effect by concomitant ASM was evaluated. Incidence of AEs was assessed.

Results In SAVANT, 53 participants were randomized to placebo (89% on baclofen) and 53 to nabiximols (81% on baclofen). In GWSP0604, 117 participants were randomized to placebo (63% on baclofen) and 124 to nabiximols (53% on baclofen). In both studies, improvement in Spasticity NRS scores and reduction in spasm frequency significantly favored nabiximols versus placebo in the overall population. Improvement in Spasticity NRS scores or decreased spasm frequency was unaffected by baclofen use, with no evidence of a difference between the treatment effects in each group (p=0.8204 and p=0.4412 in SAVANT; p=0.6192 and p=0.1792 in GWSP0604). In GWSP0604, no significant difference between treatment effects in groups was observed when the number of ASMs was evaluated (0, 1, 2+). The safety profile of nabiximols was manageable and consistent with the known safety profile of the approved medication in the European Union.

Conclusions Nabiximols showed significant and sustained treatment effect on Spasticity NRS score and spasm frequency in PwMS regardless of use of concomitant ASMs, such as baclofen.

Authors/Disclosures
Faria S. Amjad, MD (Medstar Georgetown University Hospital) PRESENTER	Dr. Amjad has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Amjad has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi Genzyme. An immediate family member of Dr. Amjad has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myer Squibb. Dr. Amjad has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche Genentech. Dr. Amjad has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Piramal.
Aaron L. Boster, MD (Ohiohealth)	Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for sanofi. Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for roche. Dr. Boster has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for novartis. Dr. Boster has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Serono. The institution of Dr. Boster has received research support from Sanofi. The institution of Dr. Boster has received research support from Roche.
Francisco J. Carod-Artal, MD, FAAN (NHS Highlands)	Dr. Carod-Artal has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Meyers. Dr. Carod-Artal has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bial. Dr. Carod-Artal has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GW. Dr. Carod-Artal has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Carod-Artal has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck Serono. Dr. Carod-Artal has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis. Dr. Carod-Artal has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Meyers Squip. Dr. Carod-Artal has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Merz. Dr. Carod-Artal has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Ipsen. Dr. Carod-Artal has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen.
Robert Chinnapongse, MD	Dr. Chinnapongse has received personal compensation for serving as an employee of Greenwich Biosciences. Dr. Chinnapongse has stock in Greenwich Biosciences.
	No disclosure on file
	No disclosure on file
Joshua R. Steinerman, MD	Dr. Steinerman has received personal compensation for serving as an employee of Greenwich Biosciences. Dr. Steinerman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Click Therapeutics. Dr. Steinerman has received stock or an ownership interest from Greenwich Biosciences. Dr. Steinerman has received stock or an ownership interest from Click Therapeutics. Dr. Steinerman has received intellectual property interests from a discovery or technology relating to health care.

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