Sativex in the management of multiple sclerosis-related spasticity: An overview of the last decade of clinical evaluation

Giacoppo, Sabrina; Bramantı, Placido; Mazzon, Emanuela

doi:10.1016/j.msard.2017.06.015

Cited by 76 publications

(55 citation statements)

References 43 publications

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“…In 2014, the American Academy of Neurology published a set of specialty guidelines that identified nabiximols, a combination THC-CBD medication, as having the highest level of empirical evidence for the treatment of pain and spasticity associated with MS [26]. Notably, nabiximols (trade name Sativex®) is available in many European countries for the treatment of neuropathic pain due to MS, though is not approved in the US [32].…”

Section: Indicationsmentioning

confidence: 99%

Clinical uses of cannabis and cannabinoids in the United States

Levinsohn

Hill

2020

Journal of the Neurological Sciences

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Section: Indicationsmentioning

confidence: 99%

Clinical uses of cannabis and cannabinoids in the United States

Levinsohn

Hill

2020

Journal of the Neurological Sciences

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“…A key step in this process was the formulation and approval of the phytocannabinoid-based medicine Sativex ® (GW Pharmaceuticals, Cambridge, UK) for the first time in 2005 [12]. It was marketed for the treatment of spasticity and pain in multiple sclerosis patients [12][13][14], and it is being investigated for other central and peripheral pathological conditions in humans [15][16][17][18]. It may also serve in Veterinary Medicine for the treatment of domestic animals, in particular for dogs affected by different pathological conditions.…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics of Sativex® in Dogs: Towards a Potential Cannabinoid-Based Therapy for Canine Disorders

et al. 2020

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The phytocannabinoid-based medicine Sativex ® is currently marketed for the treatment of spasticity and pain in multiple sclerosis patients and is being investigated for other central and peripheral pathological conditions. It may also serve in Veterinary Medicine for the treatment of domestic animals, in particular for dogs affected by different pathologies, including human-like pathological conditions. With the purpose of assessing different dosing paradigms for using Sativex in Veterinary Medicine, we investigated its pharmacokinetics when administered to naïve dogs via sublingual delivery. In the single dose arm of the study, adult Beagle dogs were treated with 3 consecutive sprays of Sativex, and blood samples were collected at 12 intervals up to 24 h later. In the multiple dose arm of the study, Beagle dogs received 3 sprays daily for 14 days, and blood samples were collected for 24 h post final dose. Blood was used to obtain plasma samples and to determine the levels of cannabidiol (CBD), ∆ 9 -tetrahydrocannabinol (∆ 9 -THC) and its metabolite 11-hydroxy-∆ 9 -THC. Maximal plasma concentrations of both ∆ 9 -THC (C max = 18.5 ng/mL) and CBD (C max = 10.5 ng/mL) were achieved 2 h after administration in the single dose condition and at 1 h in the multiple dose treatment (∆ 9 -THC: C max = 24.5 ng/mL; CBD: C max = 15.2 ng/mL). 11-hydroxy-∆ 9 -THC, which is mainly formed in the liver from ∆ 9 -THC, was almost undetected, which is consistent with the use of sublingual delivery. A potential progressive accumulation of both CBD and ∆ 9 -THC was detected following repeated exposure, with maximum plasma concentrations for both cannabinoids being achieved following multiple dose. Neurological status, body temperature, respiratory rate and some hemodynamic parameters were also recorded in both conditions, but in general, no changes were observed. In conclusion, this study demonstrates that single or multiple dose sublingual administration of Sativex to naïve dogs results in the expected pharmacokinetic profile, with maximal levels of phytocannabinoids detected at 1-2 h and suggested progressive accumulation after the multiple dose treatment.

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“…Sativex is an oromucosal plant-based cannabinoid spray. It is mainly used in patients with multiple sclerosis where it is able to relieve spasticity-related and neuropathic pain [41]. Also patients with chronic pain and post-operative pain experience beneficial effects of Sativex.…”

Section: Sativex® (Nabiximols)mentioning

confidence: 99%

“…These effects occurred in <10% of people and usually appear during the first 4 weeks of treatment. More serious effects (allergic phenomena, euphoria, psychosis, panic, hallucinations, paranoia, suicidal ideation, memory changes, and cognitive decline) were seen in <1% of people [41]. No clinical trials have been performed on the efficacy and safety of Sativex in patients with IBD.…”

Section: Sativex® (Nabiximols)mentioning

confidence: 99%

Cannabis, a potential treatment option in pediatric IBD? Still a long way to go

Halbmeijer

Groeneweg

Ridder

2019

Expert Review of Clinical Pharmacology

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Introduction: The onset of inflammatory bowel disease (IBD) in children is rising. Current treatment options are based on immunomodulatory therapy. Alternative treatment options are upcoming since they appear to be effective in individual patients. Cannabis might relief IBD symptoms in these cases and improve quality of life. Recent evidence suggests a potential anti-inflammatory effect of cannabis. Areas covered: This review presents an overview of recent literature on the use of cannabis in IBD focussing on pediatric IBD patients. Background information on the role of the endocannabinoid system within the gastrointestinal tract is presented. Other modalities of cannabis and its purified ingredients will be discussed as well, with attention to its applicability in children with IBD. Expert opinion: More research is needed on the efficacy and safety of cannabis in pediatric IBD. Studies are well underway, but until then the use of cannabis in pediatric IBD cannot be recommended. ARTICLE HISTORY

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Sativex in the management of multiple sclerosis-related spasticity: An overview of the last decade of clinical evaluation

Cited by 76 publications

References 43 publications

Clinical uses of cannabis and cannabinoids in the United States

Clinical uses of cannabis and cannabinoids in the United States

Pharmacokinetics of Sativex® in Dogs: Towards a Potential Cannabinoid-Based Therapy for Canine Disorders

Cannabis, a potential treatment option in pediatric IBD? Still a long way to go

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