Cannabinoid Spray Effectively Relieves MS-Related Spasticity

BARCELONA—When added to other antispasticity treatments, an oromucosal spray containing approximately equal amounts of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) provides effective symptomatic relief of treatment-resistant MS spasticity, according to a study presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The drug also is well tolerated in clinical practice.

“The results for spasticity evolution and tolerability in this patient cohort … compare favorably with results reported in randomized controlled trials and other observational studies of THC:CBD oromucosal spray,” said Maria Trojano, MD, Director of the Department of Basic Medical Sciences, Neurosciences, and Sensory Organs at the University of Bari in Italy, and her colleagues.

Randomized controlled trials indicate that THC:CBD oromucosal spray significantly reduces MS spasticity, compared with placebo, and does not raise significant tolerability concerns. German investigators initiated the prospective, noninterventional Mobility Improvement (MOVE) 2 study to examine the spray’s efficacy and tolerability in everyday clinical practice. Patients received treatment with the spray according to its approved use label in the outpatient setting in Europe.

Several Italian centers joined the MOVE 2 study, and Italy became the first country to reach the recruitment target of 300 or more patients for a preplanned interim analysis. Specialist MS centers in Italy are collecting data on MS spasticity from electronic case record forms and patients’ diaries at baseline and after one month (ie, Visit 1) and three months (ie, Visit 3) of treatment with THC:CBD oromucosal spray. The researchers are measuring effectiveness by rates of treatment continuation and changes from baseline in scores on the spasticity numerical rating scale (NRS) and modified Ashworth scale. The researchers also are inquiring about tolerability and adverse events.

In all, 322 patients (58.3% female, mean age 51.1) with treatment-resistant MS spasticity were recruited at 34 Italian MS centers. Baseline antispasticity medicines included baclofen (71.1%), gabapentin–pregabalin (10.9%), benzodiazepines (6.8%), and tizanidine (5.9%). About half of patients were receiving concomitant physiotherapy.

Mean doses of the spray were 6.1 sprays/day at Visit 1 and 5.1 sprays/day at Visit 3. At Visit 1, 82.9% of patients had an initial response to the THC:CBD oromucosal spray (ie, an improvement from baseline NRS score of at least 20%) and continued with treatment. At Visit 3, 24.6% of patients with available data had a clinically relevant response to the spray (ie, improvement from baseline NRS score of at least 30%) and continued with treatment. An additional 53.2% of patients continued to use the spray after Visit 3 although their improvement on the spasticity NRS was less than 30%.

Mean spasticity NRS score was 6.8 at baseline. The score decreased to 5.5 in patients with available data at Visit 3, representing a significant 19.1% improvement. Mean modified Ashworth scale score was 2.6 at baseline. The score decreased to 2.2 at Visit 1 and was 2.3 in patients with available data at Visit 3.

Rates of treatment discontinuation were 8.7% at Visit 1 and 22.2% at Visit 3. The main reasons for treatment discontinuation were lack of effectiveness (42%), lack of tolerability (42%), and pregnancy or other reasons (16%). Approximately 13% of patients reported at least one adverse event. All nonserious adverse events were mild to moderate. Adverse events with an incidence of 1% or greater included dizziness, confusion, nausea, and somnolence. Two serious adverse events, mental impairment and suicidal ideation, were considered as possibly related to treatment. One death was considered unrelated to treatment.