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https://www.readbyqxmd.com/read/29923025/cannabinoids-for-treatment-of-ms-symptoms-state-of-the-evidence
#1
REVIEW
Jessica Rice, Michelle Cameron
PURPOSE OF REVIEW: Cannabis and cannabinoids have been used medically and recreationally for thousands of years and recently there has been a growing body of research in this area. With increased access now that medical marijuana is available in many jurisdictions, patients and providers want to know more about the evidence for benefits and risks of cannabinoid use. This paper provides an overview of the available cannabinoid-based formulations, a summary of the highest quality evidence for the use of cannabinoids for treating spasticity and pain associated with multiple sclerosis (MS), and a discussion of possible dosing regimens based on information from these studies...
June 19, 2018: Current Neurology and Neuroscience Reports
https://www.readbyqxmd.com/read/29792372/sativex%C3%A2-as-add-on-therapy-vs-further-optimized-first-line-antispastics-savant-in-resistant-multiple-sclerosis-spasticity-a-double-blind-placebo-controlled-randomised-clinical-trial
#2
Jolana Markovà, Ute Essner, Bülent Akmaz, Marcella Marinelli, Christiane Trompke, Arnd Lentschat, Carlos Vila Silván
Purpose/aim: To evaluate the efficacy of tetrahydrocannabinol [THC]:cannabidiol [CBD] oromucosal spray (Sativex®) as add-on therapy to optimized standard antispasticity treatment in patients with moderate to severe multiple sclerosis (MS) spasticity. METHODS: Sativex as Add-on therapy Vs. further optimized first-line ANTispastics (SAVANT) was a two-phase trial. In Phase A, eligible patients received add-on THC:CBD spray for 4 weeks to identify initial responders (≥ 20% improvement from baseline in spasticity 0-10 numerical rating scale [NRS] score)...
May 24, 2018: International Journal of Neuroscience
https://www.readbyqxmd.com/read/29776349/randomised-controlled-trial-rct-of-cannabinoid-replacement-therapy-nabiximols-for-the-management-of-treatment-resistant-cannabis-dependent-patients-a-study-protocol
#3
Anjali K Bhardwaj, David J Allsop, Jan Copeland, Iain S McGregor, Adrian Dunlop, Marian Shanahan, Raimondo Bruno, Nghi Phung, Mark Montebello, Craig Sadler, Jessica Gugusheff, Melissa Jackson, Jennifer Luksza, Nicholas Lintzeris
BACKGROUND: The cannabis extract nabiximols (Sativex®) effectively supresses withdrawal symptoms and cravings in treatment resistant cannabis dependent individuals, who have high relapse rates following conventional withdrawal treatments. This study examines the efficacy, safety and cost-effectiveness of longer-term nabiximols treatment for outpatient cannabis dependent patients who have not responded to previous conventional treatment approaches. METHODS/DESIGN: A phase III multi-site outpatient, randomised, double-blinded, placebo controlled parallel design, comparing a 12-week course of nabiximols to placebo, with follow up at 24 weeks after enrolment...
May 18, 2018: BMC Psychiatry
https://www.readbyqxmd.com/read/29761015/the-influence-of-thc-cbd-oromucosal-spray-on-driving-ability-in-patients-with-multiple-sclerosis-related-spasticity
#4
Elisabeth G Celius, Carlos Vila
Background: Driving ability is a key function for the majority of patients with multiple sclerosis (MS) to help maintain daily interactions. Both physical and cognitive disability, as well as treatments, may affect the ability to drive. Spasticity is a common symptom associated with MS, and it may affect driving performance either directly or via the medications used to treat it. In this article, we review the evidence relating the antispasticity medicine, Δ9 -tetrahydrocannabinol:cannabidiol (THC:CBD) oromucosal spray (Sativex® ), and its potential impact on driving performance...
May 2018: Brain and Behavior
https://www.readbyqxmd.com/read/29683408/palatability-and-oral-cavity-tolerability-of-thc-cbd-oromucosal-spray-and-possible-improvement-measures-in-multiple-sclerosis-patients-with-resistant-spasticity-a-pilot-study
#5
Giacomo Lus, Roberto Cantello, Maura Chiara Danni, Agusto Rini, Paola Sarchielli, Tiziana Tassinari, Elisabetta Signoriello
AIM: Complaints about Δ9 -tetrahydrocannabinol (THC):cannabidiol (CBD) oromucosal spray (Sativex® ; GW Pharma Ltd, Salisbury, UK) in the management of multiple sclerosis spasticity include unpleasant taste and oral mucosal anomalies. This pilot study assessed the use of sugar-free chewing gum and/or a refrigerated bottle of THC:CBD oromucosal spray to mitigate these effects. MATERIALS & METHODS: Patients with multiple sclerosis spasticity (n = 52) at six sites in Italy who were receiving THC:CBD oromucosal spray and had associated oral mucosal effects were randomized into Group A (chewing gum; n = 15); Group B (cold bottle; n = 20); and Group C (cold bottle + chewing gum; n = 17)...
April 2018: Neurodegenerative Disease Management
https://www.readbyqxmd.com/read/29582946/-effects-of-cannabis-extract-premedication-on-anesthetic-depth
#6
Carlos Ibera, Ben Shalom, Fayez Saifi, Joshua Shruder, Elyad Davidson
BACKGROUND: Cannabis is the most widely used illicit drug in the world, used by approximately 2.7-4.9% of the world's population, and 7.6-10.2% of Israel's adults. During the past few years, legal systems around the world have enacted large scale adoption of the legalization of both medical and recreational cannabis. Anesthetists should therefore be prepared to treat patients who used cannabis and are undergoing elective or emergency operations. However, the interactions between cannabinoids and general anesthetic agents and the possible implications for patient care are not yet fully understood...
March 2018: Harefuah
https://www.readbyqxmd.com/read/29528549/clinical-response-to-nabiximols-correlates-with-the-downregulation-of-immune-pathways-in-multiple-sclerosis
#7
M Sorosina, F Clarelli, L Ferrè, A M Osiceanu, N T Unal, E Mascia, V Martinelli, G Comi, F Benigni, F Esposito, F Martinelli Boneschi
BACKGROUND AND PURPOSE: Nabiximols (Sativex® ) is a cannabinoid-based compound used for the treatment of moderate to severe spasticity in multiple sclerosis (MS). The aim of the study was to investigate the effect of the administration of Nabiximols on blood transcriptome profile of patients with MS and to interpret it in the context of pathways and networks. METHODS: Whole-genome expression profiling was performed in whole blood of 33 subjects with MS at baseline and after 4 weeks of drug treatment...
March 12, 2018: European Journal of Neurology: the Official Journal of the European Federation of Neurological Societies
https://www.readbyqxmd.com/read/29385147/nabiximols-combined-with-motivational-enhancement-cognitive-behavioral-therapy-for-the-treatment-of-cannabis-dependence-a-pilot-randomized-clinical-trial
#8
RANDOMIZED CONTROLLED TRIAL
Jose M Trigo, Alexandra Soliman, Lena C Quilty, Benedikt Fischer, Jürgen Rehm, Peter Selby, Allan J Barnes, Marilyn A Huestis, Tony P George, David L Streiner, Gregory Staios, Bernard Le Foll
BACKGROUND: The current lack of pharmacological treatments for cannabis use disorder (CUD) warrants novel approaches and further investigation of promising pharmacotherapy. We previously showed that nabiximols (27 mg/ml Δ9-tetrahydrocannabinol (THC)/ 25 mg/ml cannabidiol (CBD), Sativex®) can decrease cannabis withdrawal symptoms. Here, we assessed in a pilot study the tolerability and safety of self-titrated nabiximols vs. placebo among 40 treatment-seeking cannabis-dependent participants...
2018: PloS One
https://www.readbyqxmd.com/read/29307505/practical-considerations-in-medical-cannabis-administration-and-dosing
#9
REVIEW
Caroline A MacCallum, Ethan B Russo
Cannabis has been employed medicinally throughout history, but its recent legal prohibition, biochemical complexity and variability, quality control issues, previous dearth of appropriately powered randomised controlled trials, and lack of pertinent education have conspired to leave clinicians in the dark as to how to advise patients pursuing such treatment. With the advent of pharmaceutical cannabis-based medicines (Sativex/nabiximols and Epidiolex), and liberalisation of access in certain nations, this ignorance of cannabis pharmacology and therapeutics has become untenable...
March 2018: European Journal of Internal Medicine
https://www.readbyqxmd.com/read/29287930/ptl401-a-new-formulation-based-on-pro-nano-dispersion-technology-improves-oral-cannabinoids-bioavailability-in-healthy-volunteers
#10
Jacob Atsmon, Irina Cherniakov, Dvora Izgelov, Amnon Hoffman, Abraham J Domb, Lisa Deutsch, Frederic Deutsch, Daphna Heffetz, Hagit Sacks
There is a growing clinical interest in developing and commercializing pharmaceutical-grade cannabinoid products, containing primarily tetrahydrocannabinol (THC) and cannabidiol (CBD). The oral bioavailability of THC and CBD is very low due to extensive "first-pass" metabolism. A novel oral THC and CBD formulation, PTL401, utilizing an advanced self-emulsifying oral drug delivery system, was designed to circumvent the "first-pass" effect. In this study, the bioavailability of THC and CBD from the PTL401 capsule was compared with similar doses from a marketed reference oromucosal spray (Sativex® )...
May 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29145345/the-role-of-sativex-in-robotic-rehabilitation-in-individuals-with-multiple-sclerosis-rationale-study-design-and-methodology
#11
RANDOMIZED CONTROLLED TRIAL
Margherita Russo, Vincenzo Dattola, Anna Lisa Logiudice, Rosella Ciurleo, Edoardo Sessa, Rosaria De Luca, Placido Bramanti, Alessia Bramanti, Antonino Naro, Rocco Salvatore Calabrò
INTRODUCTION: Currently, none of the available multiple sclerosis (MS) disease-modifying medications has been shown to stop or reverse gait disability. Recently, the nabiximols has been tested for the treatment of spasticity and walking impairment in MS. Nabiximols (trade name Sativex) is an oromucosal spray formulation containing 1:1 fixed ratio of delta-9-tetrahydrocannabinol and cannabidiol derived from cloned Cannabis sativa L. plant. METHOD AND ANALYSIS: A single-center, prospective, parallel design, single-blind trial will be conducted at the IRCCS Neurolesi "Bonino-Pulejo" (Italy) involving MS patients affected by spasticity and undergoing a Robotic Rehabilitation training...
November 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29125702/single-dose-pharmacokinetics-of-oral-cannabidiol-following-administration-of-ptl101-a-new-formulation-based-on-gelatin-matrix-pellets-technology
#12
Jacob Atsmon, Daphna Heffetz, Lisa Deutsch, Frederic Deutsch, Hagit Sacks
Cannabidiol (CBD) is the main nonpsychoactive component of the cannabis plant. It has been associated with antiseizure, antioxidant, neuroprotective, anxiolytic, anti-inflammatory, antidepressant, and antipsychotic effects. PTL101 is an oral gelatin matrix pellets technology-based formulation containing highly purified CBD embedded in seamless gelatin matrix beadlets. Study objectives were to evaluate the safety and tolerability of PTL101 containing 10 and 100 mg CBD, following single administrations to healthy volunteers and to compare the pharmacokinetic profiles and relative bioavailability of CBD with Sativex oromucosal spray (the reference product) in a randomized, crossover study design...
November 10, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29055461/sativex-in-the-management-of-multiple-sclerosis-related-spasticity-an-overview-of-the-last-decade-of-clinical-evaluation
#13
REVIEW
Sabrina Giacoppo, Placido Bramanti, Emanuela Mazzon
BACKGROUND: Spasticity is a common symptom of multiple sclerosis (MS) affecting about 80% of MS patients. Numerous lines of evidence suggest that spasticity due to its complexity is not adequately managed with conventional anti-spastic therapies. Therefore, in order to improve the outcomes for the majority of MS patients, alternative approaches are needed to be discovered. Over the last years, the use of cannabinoid compounds as a potential treatment for MS-related symptoms has aroused great interest, owing to encouraging preclinical and clinical studies...
October 2017: Multiple Sclerosis and related Disorders
https://www.readbyqxmd.com/read/28929471/-delta-9-tetrahydrocannabinol-cannabidiol-in-the-treatment-of-spasticity-in-chronic-spinal-cord-injury-a-clinical-experience
#14
C Grao-Castellote, F Torralba-Collados, L M Gonzalez, M Giner-Pascual
INTRODUCTION: Spasticity in chronic spinal cord injury is a condition that can have negative repercussions on the patient's quality of life. Its treatment is complex and sometimes the outcome is insufficient. Cannabinoids have recently been used in multiple sclerosis to successfully treat spasticity that is refractory to other therapies. AIM: To quantify the clinical response of a group of patients with spastic chronic spinal cord injury to the orally administered drug delta-9-tetrahydrocannabinol-cannabidiol (Sativex ®) as medication for use in special situations...
October 1, 2017: Revista de Neurologia
https://www.readbyqxmd.com/read/28923526/results-of-a-double-blind-randomized-placebo-controlled-study-of-nabiximols-oromucosal-spray-as-an-adjunctive-therapy-in-advanced-cancer-patients-with-chronic-uncontrolled-pain
#15
Aron H Lichtman, Eberhard Albert Lux, Robert McQuade, Sandro Rossetti, Raymond Sanchez, Wei Sun, Stephen Wright, Elena Kornyeyeva, Marie T Fallon
CONTEXT: Prior Phase 2/3 studies found that cannabinoids might provide adjunctive analgesia in advanced cancer patients with uncontrolled pain. OBJECTIVES: To assess adjunctive nabiximols (Sativex® ), an extract of Cannabis sativa containing two potentially therapeutic cannabinoids (Δ9-tetrahydrocannabinol [27 mg/mL] and cannabidiol [25 mg/mL]), in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy. METHODS: Phase 3, double-blind, randomized, placebo-controlled trial in patients with advanced cancer and average pain Numerical Rating Scale scores ≥4 and ≤8 despite optimized opioid therapy...
February 2018: Journal of Pain and Symptom Management
https://www.readbyqxmd.com/read/28890215/piperine-pro-nanolipospheres-as-a-novel-oral-delivery-system-of-cannabinoids-pharmacokinetic-evaluation-in-healthy-volunteers-in-comparison-to-buccal-spray-administration
#16
Irina Cherniakov, Dvora Izgelov, Dinorah Barasch, Elyad Davidson, Abraham J Domb, Amnon Hoffman
Nowadays, therapeutic indications for cannabinoids, specifically Δ9 -tetrahydrocannabinol (THC) and Cannabidiol (CBD) are widening. However, the oral consumption of the molecules is very limited due to their highly lipophilic nature that leads to poor solubility at the aqueous environment. Additionally, THC and CBD are prone to extensive first pass mechanisms. These absorption obstacles render the molecules with low and variable oral bioavailability. To overcome these limitations we designed and developed the advanced pro-nanolipospheres (PNL) formulation...
November 28, 2017: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/28882919/a-randomised-controlled-cross-over-double-blind-pilot-study-protocol-on-thc-cbd-oromucosal-spray-efficacy-as-an-add-on-therapy-for-post-stroke-spasticity
#17
RANDOMIZED CONTROLLED TRIAL
Lucio Marinelli, Maurizio Balestrino, Laura Mori, Luca Puce, Gian Marco Rosa, Laura Giorello, Antonio Currà, Francesco Fattapposta, Carlo Serrati, Carlo Gandolfo, Giovanni Abbruzzese, Carlo Trompetto
INTRODUCTION: Stroke is the most disabling neurological disorder and often causes spasticity. Transmucosal cannabinoids (tetrahydrocannabinol and cannabidiol (THC:CBD), Sativex) is currently available to treat spasticity-associated symptoms in patients with multiple sclerosis. Cannabinoids are being considered useful also in the treatment of pain, nausea and epilepsy, but may bear and increased risk for cardiovascular events. Spasticity is often assessed with subjective and clinical rating scales, which are unable to measure the increased excitability of the monosynaptic reflex, considered the hallmark of spasticity...
September 7, 2017: BMJ Open
https://www.readbyqxmd.com/read/28822167/-european-union-regulatory-and-quality-requirements-for-botanical-drugs-and-their-implications-for-chinese-herbal-medicinal-products-development
#18
You-Ping Zhu
This paper introduces regulatory pathways and characteristic quality requirements for marketing authorization of herbal medicinal products in the European Union(EU), and the legal status and applications of "European Union list of herbal substances, preparations and combinations" and "European Union herbal monographs". Also introduced are Chinese herbs that have been granted the EU list entry, those with EU herbal monographs, and registered EU traditional herbal medicinal products with Chinese herbs as active ingredients...
June 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/28763462/sativex-in-resistant-multiple-sclerosis-spasticity-discontinuation-study-in-a-large-population-of-italian-patients-sa-fe-study
#19
Silvia Messina, Claudio Solaro, Isabella Righini, Roberto Bergamaschi, Simona Bonavita, Roberto Bruno Bossio, Vincenzo Brescia Morra, Gianfranco Costantino, Paola Cavalla, Diego Centonze, Giancarlo Comi, Salvatore Cottone, Maura Chiara Danni, Ada Francia, Alberto Gajofatto, Claudio Gasperini, Mauro Zaffaroni, Loredana Petrucci, Elisabetta Signoriello, Giorgia Teresa Maniscalco, Gabriella Spinicci, Manuela Matta, Massimiliano Mirabella, Graziella Pedà, Letizia Castelli, Marco Rovaris, Edoardo Sessa, Daniele Spitaleri, Damiano Paolicelli, Alfredo Granata, Mario Zappia, Francesco Patti
BACKGROUND: The approval of Sativex for the management of multiple sclerosis (MS) spasticity opened a new opportunity to many patients. In Italy, the healthcare payer can be fully reimbursed by the involved pharma company with the cost of treatment for patients not responding after a 4 week (28 days) trial period (Payment by Results, PbR), and 50% reimbursed with the cost of 6 weeks (42 days) treatment for other patients discontinuing (Cost Sharing, CS). The aim of our study was to describe the Sativex discontinuation profile from a large population of spasticity treated Italian MS patients...
2017: PloS One
https://www.readbyqxmd.com/read/28716266/sativex%C3%A2-effects-on-promoter-methylation-and-on-cnr1-cnr2-expression-in-peripheral-blood-mononuclear-cells-of-progressive-multiple-sclerosis-patients
#20
Massimo Santoro, Massimiliano Mirabella, Chiara De Fino, Assunta Bianco, Matteo Lucchini, Francesco Losavio, Andrea Sabino, Viviana Nociti
Multiple sclerosis (MS) is a chronic demyelinating central nervous system (CNS) disease that involve oligodendrocyte loss and failure to remyelinate damaged brain areas causing a progressive neurological disability. Studies in MS mouse model suggest that cannabinoids ameliorate symptoms as spasticity, tremor and pain reducing inflammation via cannabinoid-mediated system. The aim of our study is to investigate the changes in cannabinoid type 1 (CNR1) and 2 (CNR2) receptors mRNA expression levels and promoter methylation in peripheral blood mononuclear cells (PBMCs) of MS secondary progressive (MSS-SP) patients treated with Sativex®...
August 15, 2017: Journal of the Neurological Sciences
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