Abstract

Objective: When Sativex ®THC:CBD cannabinoid-based oromucosal spray was first approved as a prescription medicine for multiple sclerosis (MS) spasticity, there was some concern about its possible long-term impact on cognition and mood. The objective of this study was therefore to assess the long-term impact of Sativex on cognitive function and mood in MS patients with spasticity. Methods: 121 patients were randomly assigned Sativex or placebo in a double-blind manner. Patients self-administered treatment daily for 48 weeks while maintaining anti-spasticity therapy. The primary endpoint was the difference between treatments in Paced Auditory Serial Addition Test (PASAT) score from baseline to end of treatment. Secondary measures included Beck Depression Inventory-II (BDI-II), Subject-, Physician- and Caregiver Global Impression of Change, and Columbia-Suicide Severity Rating Scale. Results: 62 patients were randomised to Sativex and 59 to placebo. There was no difference in the effect of Sativex on PASAT and BDI-II scores compared with placebo. Subject-, Physician- and Caregiver-rated improvements in spasticity with Sativex were all statistically significant. The mean daily dose of Sativex declined gradually to 6.4 sprays per day. Conclusion: Long-term treatment with Sativex was not associated with cognitive decline or significant changes in mood in this prone population sample. Sativex was efficacious and well tolerated across the study period and no new safety concerns were identified.

Highlights

  • Spasticity affects around 80% of multiple sclerosis MS patients and is often classed as moderate to severe in magnitude, leading to significant impairment of the patient [1]

  • The endocannabinoid system modulator Sativex (GW Pharma Ltd.) is formulated from plant-based extracts prepared from fully standardised chemotypes of Cannabis sativa L. plants developed to produce high and reproducible yields of the two principal cannabinoids, Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD), which are present at an approximate 1:1 fixed ratio in Sativex, with minor amounts of other cannabinoids and terpenes [4]

  • Exclusion criteria: Patients were excluded if they: had any current or past history of drug or alcohol abuse or significant psychiatric illness, other than depression associated with MS; were hypersensitive to cannabinoids or any of the excipients used; were female and of child bearing potential or male whose partner was of child bearing potential, unless willing to ensure effective contraception was used throughout the study; were female and pregnant, lactating or planning pregnancy; had received an investigational medicinal product within 12 weeks of screening; had any concomitant disorders or abnormalities that could either put the patient at risk, affect the patient’s ability to participate or influence the result of the study

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Summary

Introduction

Spasticity (muscle stiffness) affects around 80% of multiple sclerosis MS patients and is often classed as moderate to severe in magnitude, leading to significant impairment of the patient [1]. Current oral medication for the treatment of spasticity includes baclofen, tizanidine, dantrolene, benzodiazepines and anticonvulsants. The clinical need for new and effective treatments for spasticity is clear. The endocannabinoid system modulator Sativex (GW Pharma Ltd.) is formulated from plant-based extracts prepared from fully standardised chemotypes of Cannabis sativa L. plants developed to produce high and reproducible yields of the two principal cannabinoids, Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD), which are present at an approximate 1:1 fixed ratio in Sativex, with minor amounts of other cannabinoids and terpenes [4]. CBD has been shown to reduce the psychoactivity of THC [5]

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