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

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 the 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 health-care 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:

• Multiple sclerosis
• THC:CBD oromucosal spray
• upper limb/hand spasticity
• medical device

Article highlights

• Patients with spasticity-related upper limb/hand impairment who are taking THC:CBD oromucosal spray may have difficulty self-administering the medication, possibly limiting adherence and treatment effectiveness.

• An application aid has become available in the EU to facilitate self-administration of THC:CBD oromucosal spray for individuals who have difficulty actuating the spray bottle.

• Pre-production testing was undertaken in current users of THC:CBD spray to evaluate validity of the instructions, ease of use of the device, and overall user satisfaction.

• Among 15 participants of the survey study, three-quarters had hand impairment and half reported difficulty administering THC:CBD spray.

• Most participants reported that instructions for use were clear, that it was easy to assemble the device, and that application of THC:CBD spray was better with versus without the device.

• Observing health-care professionals could not foresee any difficulties with patients’ ability to use the device.

• The application aid for THC:CBD spray may improve self-management in patients with spasticity-related upper limb/hand impairment.

Acknowledgments

Medical writing assistance was provided by Kerry Dechant on behalf of Content Ed Net (Madrid, Spain) with funding from Almirall (Barcelona, Spain).

Declaration of interest

Paloma Montero-Escribano has received research support from Almirall S.A.

Carlos Vila Silván is a fulltime employee of Almirall S.A., Barcelona, Spain.

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 that disclosed. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

The study was funded by Almirall S.A., Barcelona, Spain.