Usability of an Application Device for Nabiximols Oromucosal Spray in Patients With Upper Limb Impaired Multiple Sclerosis

Abstract

Aim: This study aimed to assess the usability of a specific EU-available application device for Sativex^® (US adopted name: nabiximols) cannabinoid-based oromucosal spray in patients with multiple sclerosis (MS) and spasticity-related upper limb and hand impairment in routine daily practice. Methods: MS patients with upper limb and hand impairment evaluated the usability of the device using an ad hoc 18-item questionnaire. Results: 60 patients were included. The comprehensibility of the instructions for use, practical handling and ergonomics of the device were rated as optimal (mean scores ≥8.9/10 across questions). Assisting trained nurses also rated the device as easy to use and helpful for drug administration (mean scores 10/10). Conclusion: The application device may assist MS patients with upper limb impairment self-administer nabiximols oromucosal spray.

Plain language summary

Many patients with multiple sclerosis lose some function in their upper limbs (arms) and hands because of spasticity, which can make it difficult to take their medication at the required times each day. Patients taking nabiximols oromucosal spray may not have the strength or coordination needed to press the spray nozzle into their mouth. To support delivery of the medicine in these patients, a specific application device has been developed that reduces the strength necessary to administer the spray. 60 patients with upper limb/hand impairment tested the device and completed an 18-item questionnaire. Patients rated the instructions for use, ease of use and ergonomic features of the device as optimal, with average scores of ≥8.9/10 across questions.

Keywords:

• application device
• multiple sclerosis
• nabiximols oromucosal spray
• upper limb impairment
• usability

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at:www.tandfonline.com/doi/full/10.2217/nmt-2022-0014

Author contributions

D Centonze conceived and designed the study. A Creta, L Gilio and R Fantozzi performed the experiments, and A Creta and R Fantozzi acquired the data. All authors analyzed and interpreted the data, prepared and made corrections and modifications to the manuscript and read and approved the final version.

Financial & competing interests disclosure

D Centonze is an Advisory Board member or has given advice to Almirall, Bayer Schering, Biogen, GW Pharmaceuticals, Merck Serono, Novartis, Roche, Sanofi-Genzyme and Teva; has received honoraria for speaking or consultation fees from Almirall, Bayer Schering, Biogen, GW Pharmaceuticals, Merck Serono, Novartis, Roche, Sanofi-Genzyme and Teva; and is the principal investigator in clinical trials for Bayer Schering, Biogen, Merck Serono, Mitsubishi, Novartis, Roche, Sanofi-Genzyme and Teva. His pre-clinical and clinical research was supported by grants from Bayer Schering, Biogen Idec, Celgene, Merck Serono, Novartis, Roche, Sanofi-Genzyme and Teva. A Creta, L Gilio and R Fantozzi have no conflicts of interest to report. The study was funded by Almirall, S.A. The funders had no role in the design of the study; in the collection, analyses or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Editorial assistance was provided by M De Simone and A Shah (Polistudium SRL, Milan, Italy). Additional editorial assistance was provided by Content Ed Net (Madrid, Spain). All editorial assistance was supported unconditionally by Almirall.

Data sharing statement

Data are available upon request to the corresponding author.