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Expert Rev Med Devices. 2019 Aug 8. doi: 10.1080/17434440.2019.1653182. [Epub ahead of print]

Application device for THC:CBD oromucosal spray in the management of resistant spasticity: pre-production testing.

Author information

1
a Neurology Service, Hospital Clínico Universitario San Carlos , Madrid , Spain.
2
b Global Medical Affairs, Almirall S.A ., Barcelona , Spain.

Abstract

Background: Patients with multiple sclerosis spasticity (MSS) and upper limb/hand impairment who are taking 9-delta-tetrahydrocannabinol:cannabidiol (THC:CBD) oromucosal spray (Sativex®) may have difficulty self-administering their medication, possibly limiting adherence and treatment effectiveness. A Class I EU device is available to support administration of THC:CBD spray. Pre-production testing was undertaken in a patient sample. Methods: Current users of THC:CBD spray were recruited to review the instruction leaflet and test the device. Patients and observing healthcare professionals (HCP) completed a purpose-designed questionnaire which captured user experience and HCP opinion. Results: Fifteen patients participated. Mean treatment time with THC:CBD spray was 4 (range: 0.1-6.1) years. 87% of participants 'always', 'often' or 'sometimes' had hand impairment, and 53% reported difficulty administering THC:CBD spray. Participants reported better application using the device (73%), with less strength required (54%). Most participants (93%) considered the instruction leaflet to be clear and many (66%) expressed interest in using the device. Most HCPs (93%) did not foresee any difficulties in use of the device. Conclusion: The proposed adherence device was useful to address self-application difficulties with THC:CBD spray in our sample. Providing the device to MSS patients with upper limb/hand spasticity impairment may restore autonomy and support adherence to THC:CBD spray.

KEYWORDS:

THC:CBD oromucosal spray; medical device; multiple sclerosis; upper limb/hand spasticity

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