Contributions
Abstract: P1873
Type: Poster
Abstract Category: Late breaking news
Background: Up to 10% of users of Sativex (a cannabinoid based oromucosal spray of 1:1 ratio 9-delta-tetrahydrocannabinol/cannabidiol approved for resistant moderate to severe multiple sclerosis (MS) spasticity symptoms) stop its use due to taste/oral cavity tolerability. As the formulation cannot be modified without complex processes, measures to address the issues are needed.
Aim: Explore the use of sugar-free chewing gum (CG) after each Sativex intake and/or having the Sativex bottle cold (CB) to improve the taste tolerability in patients already on treatment who had complaints on taste while maintaining treatment effectiveness.
Methods: Open-label, prospective, multicenter, non-pharmacological, randomized, minor interventional pilot study. Patients' overall impression of taste (categorical scale), associated complaints (dry mouth, dysgeusia, oral mucosa discomfort (irritation, pain)), 0-10 NRS MS spasticity score and other parameters collected weekly for 1 month. 6 sites in Italy involved. Key selection criteria: informed consent, age ≥18y, stable Sativex doses for at least 3 months, use according to label, presence of Sativex related mild-to-moderate taste complaints/associated symptoms. Smokers were excluded.
Results: 52 patients enrolled (ITT, PP: 46), mean age 52y, 61.5% female, 13.2y with MS (52% on SPMS), EDSS mean score 6.2, 63.5% on Baclofen + Sativex, 25% on other anti-spasticity drugs + Sativex, 86% on physiotherapy. Mean time on Sativex: 27 months (SD 24.8), mean dose: 5 sprays/d. Overall Sativex taste perception evolution bad taste (sample %, CG-CB-Both), ITT, V0: 87%-90%-100%, V1 (+4 weeks): 40%-80%-18%. PP results similar. Changes perceived from second week onwards. Bad taste associated symptoms also improved: 0-10 NRS means (ITT): dry mouth: 4.73 to 3.05, dysgeusia: 4.4 to 2.6, irritation/pain: 2.8 to 1.7, higher changes in CG groups. Spasticity NRS from V0 6.1 (SD 2.2) to V1 5.4 (SD 2.1), no differences between CG/CB/Both groups. Spasms count from V0: 4.1 to V1 3.9/d. No adverse events. No changes in spray/d dose. CG/CB/Both use: 90% intakes. -8%/-12% reduction in mood disorders. Other MS symptoms unchanged. No adverse events. CG cost 1.5€/week.
Conclusion: The use of chewing gum shows to improve the perception of taste positively in more than half of Sativex users with mild to moderate taste and associated complaints w/o affecting MS spasticity control. Using a cold bottle of Sativex helps further. Treatment adherence may benefit.
Disclosure: Study sponsored by Almirall S.A., Barcelona, Spain
Abstract: P1873
Type: Poster
Abstract Category: Late breaking news
Background: Up to 10% of users of Sativex (a cannabinoid based oromucosal spray of 1:1 ratio 9-delta-tetrahydrocannabinol/cannabidiol approved for resistant moderate to severe multiple sclerosis (MS) spasticity symptoms) stop its use due to taste/oral cavity tolerability. As the formulation cannot be modified without complex processes, measures to address the issues are needed.
Aim: Explore the use of sugar-free chewing gum (CG) after each Sativex intake and/or having the Sativex bottle cold (CB) to improve the taste tolerability in patients already on treatment who had complaints on taste while maintaining treatment effectiveness.
Methods: Open-label, prospective, multicenter, non-pharmacological, randomized, minor interventional pilot study. Patients' overall impression of taste (categorical scale), associated complaints (dry mouth, dysgeusia, oral mucosa discomfort (irritation, pain)), 0-10 NRS MS spasticity score and other parameters collected weekly for 1 month. 6 sites in Italy involved. Key selection criteria: informed consent, age ≥18y, stable Sativex doses for at least 3 months, use according to label, presence of Sativex related mild-to-moderate taste complaints/associated symptoms. Smokers were excluded.
Results: 52 patients enrolled (ITT, PP: 46), mean age 52y, 61.5% female, 13.2y with MS (52% on SPMS), EDSS mean score 6.2, 63.5% on Baclofen + Sativex, 25% on other anti-spasticity drugs + Sativex, 86% on physiotherapy. Mean time on Sativex: 27 months (SD 24.8), mean dose: 5 sprays/d. Overall Sativex taste perception evolution bad taste (sample %, CG-CB-Both), ITT, V0: 87%-90%-100%, V1 (+4 weeks): 40%-80%-18%. PP results similar. Changes perceived from second week onwards. Bad taste associated symptoms also improved: 0-10 NRS means (ITT): dry mouth: 4.73 to 3.05, dysgeusia: 4.4 to 2.6, irritation/pain: 2.8 to 1.7, higher changes in CG groups. Spasticity NRS from V0 6.1 (SD 2.2) to V1 5.4 (SD 2.1), no differences between CG/CB/Both groups. Spasms count from V0: 4.1 to V1 3.9/d. No adverse events. No changes in spray/d dose. CG/CB/Both use: 90% intakes. -8%/-12% reduction in mood disorders. Other MS symptoms unchanged. No adverse events. CG cost 1.5€/week.
Conclusion: The use of chewing gum shows to improve the perception of taste positively in more than half of Sativex users with mild to moderate taste and associated complaints w/o affecting MS spasticity control. Using a cold bottle of Sativex helps further. Treatment adherence may benefit.
Disclosure: Study sponsored by Almirall S.A., Barcelona, Spain