Safety and tolerability of nabiximols oromucosal spray: a review of more than 15 years” accumulated evidence from clinical trials

González, José María Prieto; Silván, Carlos Vila

doi:10.1080/14737175.2021.1935879

Cited by 13 publications

(20 citation statements)

References 48 publications

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“…Although incidences of AEs in 2 long-term observational studies [25, 26] were comparatively high relative to other included studies, the AEs were reported as mild and occurred mainly during titration. More detailed information regarding the safety and tolerability of NAB in RCTs [20] and observational studies [21] is available in 2 recently published comprehensive reviews.…”

Section: Discussionmentioning

confidence: 99%

“…Eligible for inclusion in this review were published RCTs or observational studies of NAB oromucosal spray conducted in adults with MS spasticity which featured a 4-week trial period to identify initial responders as per the approved label [14]. Studies which met this criterion were identified from reference lists of recent comprehensive reviews of NAB oromucosal spray known to the authors [18, 20, 21], supplemented by a PubMed search (from inception to June 30, 2021) using the search terms “Sativex” OR “nabiximols” AND “multiple sclerosis spasticity” AND “numerical rating scale” to identify any newer published articles not included in the abovementioned comprehensive reviews.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Review of Available Data for the Efficacy and Effectiveness of Nabiximols Oromucosal Spray (Sativex®) in Multiple Sclerosis Patients with Moderate to Severe Spasticity

Conte

Silván

2021

Neurodegener Dis

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Background: Sativex (USAN: nabiximols) oromucosal spray is indicated for treatment of multiple sclerosis (MS) patients with moderate to severe spasticity and inadequate response to other antispasticity medications who demonstrate clinically significant improvement during an initial trial of therapy. This narrative review investigated the efficacy and effectiveness of nabiximols oromucosal spray for moderate to severe MS spasticity by examining spasticity 010 Numerical Rating Scale (NRS) data from interventional and observational studies which featured a 4-week trial period as per the European Union approved label. Summary: Across both study types, clinically relevant and statistically significant reductions in mean MS spasticity 0–10 NRS scores were measured soon after treatment start and were maintained in the mid to long term in treatment responders. Initial responder rates (≥ 20% NRS improvement from baseline at week 4) ranged from 47.6% to 81.4%, tending lower in the randomized clinical trials setting. Clinically relevant responder rates (≥ 30% NRS improvement from baseline at week 12) were similar between study types (range 3041%) except for one outlier (74% in an observational study). Two open studies reported treatment continuation for ≥ 18 months in approximately half of patients who initiated treatment. In most longer-term studies, symptomatic improvement in MS spasticity was maintained at mean daily dosages of about 67 sprays/day. Safety was consistent with the known profile of nabiximols. Key messages: Experimental and observational studies of nabiximols oromucosal spray recorded similar findings. About half to two-thirds of MS patients who begin treatment will perceive initial symptomatic relief of spasticity within the 4-week trial period. About 40% of patients who initiate treatment will reach the ≥ 30% NRS improvement threshold at 3 months, comprising the majority of patients who continue long-term treatment. A trial of therapy with nabiximols is useful to identify patients most likely to gain longer-term improvement in spasticity symptoms and discontinue those with insufficient benefit.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Review of Available Data for the Efficacy and Effectiveness of Nabiximols Oromucosal Spray (Sativex®) in Multiple Sclerosis Patients with Moderate to Severe Spasticity

Conte

Silván

2021

Neurodegener Dis

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Section: Introductionmentioning

confidence: 99%

“…However, Sativex is not yet approved by the US FDA, with the agency indicating that there may be associated health risks, as there is limited research regarding its safety. Confusion, ideomotor slowing, fatigue, nausea and dizziness in MS patients, and nausea, vomiting, somnolence and dizziness in cancer patients are reported as some of the most prevalent side effects of Sativex [40,41]. The discovery of biological targets that are modulated by cannabis-derived components such as G protein-coupled receptors (GPCRs), including cannabinoid receptor 1 (CB1R), cannabinoid receptor 2 (CB2R), ion channels, and various nuclear receptors, has increased our understanding of how cannabis interacts with the human body [42][43][44].…”

Section: Introductionmentioning

confidence: 99%

A Proteomic View of Cellular and Molecular Effects of Cannabis

Abyadeh¹,

Gupta

Paulo

et al. 2021

Biomolecules

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Cannabis (Cannabis sativa), popularly known as marijuana, is the most commonly used psychoactive substance and is considered illicit in most countries worldwide. However, a growing body of research has provided evidence of the therapeutic properties of chemical components of cannabis known as cannabinoids against several diseases including Alzheimer’s disease (AD), multiple sclerosis (MS), Parkinson’s disease, schizophrenia and glaucoma; these have prompted changes in medicinal cannabis legislation. The relaxation of legal restrictions and increased socio-cultural acceptance has led to its increase in both medicinal and recreational usage. Several biochemically active components of cannabis have a range of effects on the biological system. There is an urgent need for more research to better understand the molecular and biochemical effects of cannabis at a cellular level, to understand fully its implications as a pharmaceutical drug. Proteomics technology is an efficient tool to rigorously elucidate the mechanistic effects of cannabis on the human body in a cell and tissue-specific manner, drawing conclusions associated with its toxicity as well as therapeutic benefits, safety and efficacy profiles. This review provides a comprehensive overview of both in vitro and in vivo proteomic studies involving the cellular and molecular effects of cannabis and cannabis-derived compounds.

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“…This edition of the Polish Journal of Neurology and Neurosurgery contains a Leading Topic dedicated to the use of cannabis-based medicine (CBM) in neurology. Growing evidence supports the application of CBM in a variety of neurological disorders such as epilepsy [1][2][3][4][5], multiple sclerosis (MS) [6][7][8][9], chronic pain [10], agitation in Alzheimer's Disease [11], Parkinson's Disease (PD) [12][13][14], Huntington's Disease [15,16], Gilles de la Tourette Syndrome (GTS) [17], and other movement disorders [15]. Although there are disparities regarding the level of evidence for the use of CBM in diverse neurological disorders, with the highest being in epilepsy and MS, in all cases it is still considered an adjuvant and/or experimental therapy.…”

mentioning

confidence: 99%