Drugs for MS.Drug fact box cannabis extract (Sativex) Version 1.0 Author

Save this PDF as:

Size: px
Start display at page:

Download "Drugs for MS.Drug fact box cannabis extract (Sativex) Version 1.0 Author"

Transcription

1 Version History Policy Title Drugs for MS.Drug fact box cannabis extract (Sativex) Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields as required by local organisations) Previous Versions Version Date Changes

2 What is this drug for? 1 Who is this drug for? 1 Drugs for multiple sclerosis Summaries of key information and evidence for efficacy and safety January 2013 Drug Facts box for Cannabis extract (Sativex) Improvement of the symptoms of spasticity caused by multiple sclerosis People with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medication, and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of Sativex therapy. Patients under age 18. Who should not be taking this drug? 1 Patients with severe cardiovascular disease. How is this drug Oromucosal spray What dose of this 1 spray contains 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg drug is cannabidiol (CBD) in 0.04 g ethanol. How often is this drug Sprays administered as needed with at least 15 minutes between sprays. The maximum recommended dose is 12. What is the cost of this drug? A 10 ml bottle of Sativex (100 sprays) = For 6 to 12, the cost per patient per year is 2,737 to 5,475. What are the adverse Most commonly: dizziness and fatigue reactions associated Application site reactions: mild to moderate stinging or burning, oral pain, with this drug? dysgeusia (taste distortion), mouth ulceration Licensing timeline Launched in the UK in June 2010 Other information: Sativex is currently a Schedule 1 drug under the Misuse of Drugs Act It is due to be reclassified. Prescriptions for Sativex must be written in the same way as they are for Schedule 2 drugs, with specific criteria to be met. 2 Studies Summary of methods Three published, double-blind,, controlled trials (RCTs) 3-5 compared Sativex with placebo for the treatment of symptoms of spasticity in patients with confirmed MS who did not obtain adequate relief with current therapy. Eligible patients had significant spasticity in at least two muscle groups, with an Ashworth score 2 or a score 4 on a patient-rated 0-to-10 scale of severity of spasticity. One of the trials had an enriched design and included only patients showing a response to Sativex treatment during a 4-week single-blind screening period. 5 The trials lasted six, 15 and 19 weeks. 3-5 Patients assessed and recorded the severity of their symptoms of spasticity and spasm frequency on a 0-to-10 numerical rating scale (NRS) daily. The primary outcome measure was the change in mean weekly NRS spasticity scores compared with the mean scores in the last seven days of baseline treatment. Quality of the trials The design of the trials was fair, because of the subjective nature of the outcomes, and the inclusion of only patients who had previously responded to Sativex in one of the trials. Main results Compared with placebo, Sativex treatment was associated with a statistically greater improvement in the patient-rated spasticity score in two trials 3,5 but there was no difference in the third trial. 4 However, the clinical importance of the improvements has been questioned. The mean differences in the changes from baseline in spasticity scores (on a 0 to 10 scale) between the Sativex groups and the placebo groups were 0.52, and points in the three trials. The proportions of patients who were classified as responders ranged from 31% to 74% in the Sativex groups and from 22% to 51% in

3 the placebo groups. Adverse events The most common adverse events occurring more frequently with Sativex than placebo were: dizziness, fatigue, somnolence, nausea and dry mouth. References 1. GW Pharma Ltd. Sativex Oromucosal Spray. SPC A guide to good practice in the management of controlled drugs in primary care (England). National Prescribing Centre Collin C, Davies P, Mutiboko IK et al. Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis. Eur J Neurol 2007;14: Collin C, Ehler E, Waberzinek G et al. A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis. Neurol Res 2010;32: Novotna A, Mares J, Ratcliffe S et al. A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols (Sativex), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis. Eur J Neurol 2011.

4 Table 1. Cannabis extract (Sativex): study design Study (n ) Collin et al., (12) 189 calculation Collin et al., (23) 337 calculation Inclusion criteria All patients had a diagnosis of MS, with spasticity that was not relieved by current therapy Stable MS for at least 3 months Spasticity in at least 2 muscle groups with an Ashworth score 2 No use of cannabis or cannabinoids in 30 days before trial entry 3-month history of spasticity due to MS Exclusion criteria Psychosis or severe psychiatric disorder other than depression Severe cardiovascular disorder including poorly controlled hypertension History of seizures Symptoms of spasticity not due to MS Any patient with a concurrent history of significant psychiatric, renal, hepatic, cardiovascular or convulsive disorders Duration of study 6 weeks including 2- week baseline 15 weeks including 1- week baseline Treatment arms, Mean number of (number of patients treated) Sativex 9.4 (SD 6.4) (124) Placebo 14.7 (SD 8.4) (65) Sativex, 8.5,, range 1-22 (167) Placebo, 15.4, range 2-23 (170) Main outcomes Primary outcomes Selected secondary outcomes Difference in mean change from baseline between Sativex and placebo in spasticity scores (0-to-10 NRS): 0.52 points (95% CI to ) * Proportion of patients who were treatment responders (Sativex vs. placebo): 40% vs. 22% * Mean daily spasm scores on a 0 to 5-point scale (p = ns) Patients global impression of change (p = ns) Difference in mean change from baseline between Sativex and placebo in mean spasticity scores (0-to-10 NRS) (last 14 days of the treatment period minus mean score at baseline): points, p = Proportion of patients who were treatment responders: 31% vs. 25%, p = Barthel Activities of Daily Living index (p = ns) Caregiver s Global Impression of Change (p = ns) Symptom severity: spasm, pain, fatigue, tremor, bladder symptoms, sleep quality (p = ns)

5 Novotna, et al., (51) 241 calculation 3-month history of spasticity due to MS Moderately severe spasticity (score 4 on a 0 to 10 patient-rated NRS) No use of cannabis or cannabinoids in 30 days before trial entry Symptoms of spasticity not due to MS Any patient with a concurrent history of significant psychiatric, renal, hepatic, cardiovascular or convulsive disorders 4-week single-blind phase to identify responders, 12-week double-blind treatment, 2-week follow up Sativex, 8.3 (SD 2.43) (124) Placebo, 8.9 (2.31) (117) Difference between Sativex and placebo mean spasticity scores (0 to 10 NRS) from randomisation: 0.84 points (95% CI to -0.4) *** Proportion of patients who were treatment responders: 74% vs. 51% *** Spasm frequency ** Sleep disruption NRS *** Barthel Activities of Daily living ** Physician and subject global impression of change * Carer global impression of change in function ** There were no significant differences between Sativex and placebo in any trial for other secondary outcomes: Modified Ashworth Scale, Motricity index, timed 10-metre walk test and quality of life measures (EQ-5D, SF-36, MSQoL-54) DB, double-blind; EQ-5D, health-related quality of life questionnaire; ITT, intention-to-treat analysis; MS, multiple sclerosis; MSQoL-54, Multiple Sclerosis Quality of Life-54; NRS, numerical rating scale; RCT, controlled trial; SD, standard deviation; SF-26, short-form 36 question quality of life questionnaire * p < 0.01; *** p < vs. control; ns, not significant

Sativex (nabiximols)

Sativex (nabiximols) Sativex (nabiximols) We hope you find the information in this factsheet helpful. If you would like to speak with someone about any aspect of MS, contact the MS Trust information team and they will help

More information

Sativex. Spirella Building, Letchworth, SG6 4ET 01462 476700 www.mstrust.org.uk reg charity no. 1088353

Sativex. Spirella Building, Letchworth, SG6 4ET 01462 476700 www.mstrust.org.uk reg charity no. 1088353 Sativex Spirella Building, Letchworth, SG6 4ET 01462 476700 www.mstrust.org.uk reg charity no. 1088353 Sativex Date of issue: July 2010 Review date: July 2011 Contents 1. Introduction 1 2. What is Sativex?

More information

Summary 1. Comparative-effectiveness

Summary 1. Comparative-effectiveness Cost-effectiveness of Delta-9-tetrahydrocannabinol/cannabidiol (Sativex ) as add-on treatment, for symptom improvement in patients with moderate to severe spasticity due to MS who have not responded adequately

More information

Peninsula Health Technology Commissioning Group

Peninsula Health Technology Commissioning Group Peninsula Health Technology Commissioning Group Health Technology Assessment and Commissioning Decision Sativex for treatment of spasticity in multiple sclerosis Clinical case: Generally supportable Cost-effectiveness

More information

Version History. Previous Versions. Drugs for MS.Drug facts box fampridine Version 1.0 Author

Version History. Previous Versions. Drugs for MS.Drug facts box fampridine Version 1.0 Author Version History Policy Title Drugs for MS.Drug facts box fampridine Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields as required

More information

Cannabis. Spirella Building, Letchworth, SG6 4ET 01462 476700 www.mstrust.org.uk reg charity no. 1088353

Cannabis. Spirella Building, Letchworth, SG6 4ET 01462 476700 www.mstrust.org.uk reg charity no. 1088353 Cannabis Spirella Building, Letchworth, SG6 4ET 01462 476700 www.mstrust.org.uk reg charity no. 1088353 Cannabis Date of issue: June 2010 Review date: June 2011 Contents 1. Introduction 1 2. Background

More information

Version History. Previous Versions. Drugs for MS.Drug facts box fingolimod Version 1.0 Author

Version History. Previous Versions. Drugs for MS.Drug facts box fingolimod Version 1.0 Author Version History Policy Title Drugs for MS.Drug facts box fingolimod Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields as required

More information

Version History. Previous Versions. for secondary progressive MS (SPMS) Policy Title. Drugs for MS.Drug facts box Interferon beta 1b

Version History. Previous Versions. for secondary progressive MS (SPMS) Policy Title. Drugs for MS.Drug facts box Interferon beta 1b Version History Policy Title Drugs for MS.Drug facts box Interferon beta 1b for secondary progressive MS (SPMS) Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review

More information

Version History. Previous Versions. Policy Title. Drugs for MS.Drug facts box Glatiramer Acetate Version 1.0 Author

Version History. Previous Versions. Policy Title. Drugs for MS.Drug facts box Glatiramer Acetate Version 1.0 Author Version History Policy Title Drugs for MS.Drug facts box Glatiramer Acetate Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields

More information

APPROVAL OF SATIVEX WITH CONDITIONS

APPROVAL OF SATIVEX WITH CONDITIONS Health Canada posts safety alerts, public health advisories, press releases and other notices from industry as a service to health professionals, consumers and other interested parties. Although Health

More information

MULTIPLE SCLEROSIS AUSTRALIA MULTIPLE SCLEROSIS RESEARCH AUSTRALIA

MULTIPLE SCLEROSIS AUSTRALIA MULTIPLE SCLEROSIS RESEARCH AUSTRALIA MULTIPLE SCLEROSIS AUSTRALIA MULTIPLE SCLEROSIS RESEARCH AUSTRALIA Submission to the ACT Legislative Assembly Health, Ageing, Community and Social Services Inquiry into the exposure draft of the Drugs

More information

Sativex Cannabis sativa L. extracts (delta-9-tetrahydrocannabinol and cannabidiol) Oromucosal Spray 5.5 / 10 ml

Sativex Cannabis sativa L. extracts (delta-9-tetrahydrocannabinol and cannabidiol) Oromucosal Spray 5.5 / 10 ml New Zealand Consumer Medicine Information Sativex Cannabis sativa L. extracts (delta-9-tetrahydrocannabinol and cannabidiol) Oromucosal Spray 5.5 / 10 ml What is in this leaflet Please read all of this

More information

PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain

PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain P a g e 1 PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain Clinical Phase 4 Study Centers Study Period 25 U.S. sites identified and reviewed by the Steering Committee and Contract

More information

Research: Medical Cannabis

Research: Medical Cannabis Research: Medical Cannabis Background The hemp plant Cannabis sativa (cannabis) is commonly known as marijuana and can be used as a therapy to alleviate symptoms such as pain and fatigue caused by chronic

More information

For personal use only

For personal use only 6 July 2015 KEY ADVANCEMENT TOWARDS COMMENCEMENT OF PHASE 1 CLINICAL STUDY OF ORAL FORMULATIONS Highlights PhytoTech Medical has submitted key documents to the Institutional Review Board (IRB or Helsinki

More information

Cannabis in the management of MS symptoms

Cannabis in the management of MS symptoms CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE LILLE Cannabis in the management of MS symptoms Patrick Vermersch University of Lille Nord de France 19 May 2012 EMSP Annual Congress 10 most common MS-related

More information

Package leaflet: Information for the patient Sativex Oromucosal Spray. (delta-9-tetrahydrocannabinol and cannabidiol)

Package leaflet: Information for the patient Sativex Oromucosal Spray. (delta-9-tetrahydrocannabinol and cannabidiol) Package leaflet: Information for the patient Sativex Oromucosal Spray (delta-9-tetrahydrocannabinol and cannabidiol) Read all of this leaflet carefully before you start using this medicine because it contains

More information

SATIVEX. London New Drugs Group APC/DTC Briefing Document. June 2010

SATIVEX. London New Drugs Group APC/DTC Briefing Document. June 2010 Page 1 London New Drugs Group APC/DTC Briefing Document SATIVEX Contents Summary 1 Background 5 Sativex 5 Controlled drug status 5 Dose and administration 6 Precautions 6 Drug interactions 6 Excipients

More information

U.S. Scientific Update Aricept 23 mg Tablets. Dr. Lynn Kramer President NeuroScience Product Creation Unit Eisai Inc.

U.S. Scientific Update Aricept 23 mg Tablets. Dr. Lynn Kramer President NeuroScience Product Creation Unit Eisai Inc. U.S. Scientific Update Aricept 23 mg Tablets Dr. Lynn Kramer President NeuroScience Product Creation Unit Eisai Inc. Unmet Need in Moderate to Severe Alzheimer s Disease (AD) Ongoing clinical deterioration

More information

Medical marijuana for pain and anxiety: A primer for methadone physicians. Meldon Kahan MD CPSO Methadone Prescribers Conference November 6, 2015

Medical marijuana for pain and anxiety: A primer for methadone physicians. Meldon Kahan MD CPSO Methadone Prescribers Conference November 6, 2015 Medical marijuana for pain and anxiety: A primer for methadone physicians Meldon Kahan MD CPSO Methadone Prescribers Conference November 6, 2015 Conflict of interest statement No conflict of interest to

More information

MARIJUANA : A DRUG, MEDICINE, OR A DRUG AS MEDICINE? Robert Roose, MD, MPH, FASAM Sisters of Providence Health System Jan 15, 2016

MARIJUANA : A DRUG, MEDICINE, OR A DRUG AS MEDICINE? Robert Roose, MD, MPH, FASAM Sisters of Providence Health System Jan 15, 2016 MARIJUANA : A DRUG, MEDICINE, OR A DRUG AS MEDICINE? Robert Roose, MD, MPH, FASAM Sisters of Providence Health System Jan 15, 2016 EDUCATIONAL OBJECTIVES Describe the mechanism of action and effects of

More information

Sativex oromucosal spray for the management of pain (non-ms)

Sativex oromucosal spray for the management of pain (non-ms) Sativex oromucosal spray for the management of pain (non-ms) Lead author: Stephen Erhorn Regional Drug & Therapeutics Centre (Newcastle) November 2014 2014 Summary Sativex is an oromucosal spray containing

More information

Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis

Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis European Journal of Neurology 2007, 14: 290 296 doi:10.1111/j.1468-1331.2006.01639.x Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis C. Collin a, P. Davies

More information

Managing MS, Managing spasticity: People with MS experiences of Sativex

Managing MS, Managing spasticity: People with MS experiences of Sativex Managing MS, Managing spasticity: People with MS experiences of Sativex Diane Redfern-Tofts Multiple Sclerosis Society October 2014 1 Contents Introduction... 3 Method... 3 Questionnaire design... 3 Respondents...

More information

The submission positioned dimethyl fumarate as a first-line treatment option.

The submission positioned dimethyl fumarate as a first-line treatment option. Product: Dimethyl Fumarate, capsules, 120 mg and 240 mg, Tecfidera Sponsor: Biogen Idec Australia Pty Ltd Date of PBAC Consideration: July 2013 1. Purpose of Application The major submission sought an

More information

BEST in MH clinical question-answering service

BEST in MH clinical question-answering service Best Evidence Summaries of Topics in Mental Healthcare BEST in MH clinical question-answering service Question In people with PTSD (including single and multiple event trauma) how effective is prazosin

More information

Long-term use of a cannabis-based medicine in the treatment of spasticity and other symptoms in multiple sclerosis

Long-term use of a cannabis-based medicine in the treatment of spasticity and other symptoms in multiple sclerosis ARTICLE Multiple Sclerosis 2006; 12: 639645 Long-term use of a cannabis-based medicine in the treatment of spasticity and other symptoms in multiple sclerosis DT Wade 1, PM Makela 1, H House 1, C Bateman

More information

2. Background This was the fourth submission for everolimus requesting listing for clear cell renal carcinoma.

2. Background This was the fourth submission for everolimus requesting listing for clear cell renal carcinoma. PUBLIC SUMMARY DOCUMENT Product: Everolimus, tablets, 5 mg and 10 mg, Afinitor Sponsor: Novartis Pharmaceuticals Australia Pty Ltd Date of PBAC Consideration: November 2011 1. Purpose of Application To

More information

Cannabis and Cannabis Based Medicine Extracts: Additional Results

Cannabis and Cannabis Based Medicine Extracts: Additional Results Cannabis and Cannabis Based Medicine Extracts: Additional Results Ethan Russo SUMMARY. This study reviews results in recent human clinical trials with cannabis based medicine extract (CBME), THC or cannabis.

More information

BEST in MH clinical question-answering service

BEST in MH clinical question-answering service Best Evidence Summaries of Topics in Mental Healthcare BEST in MH clinical question-answering service Question In adults with a diagnosis of psychotic / delusional depression how effective is electroconvulsive

More information

1. Comparative effectiveness of alemtuzumab

1. Comparative effectiveness of alemtuzumab Cost-effectiveness of alemtuzumab (Lemtrada ) for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease defined by clinical or imaging features The NCPE has issued

More information

Cost-effectiveness of teriflunomide (Aubagio ) for the treatment of adult patients with relapsing remitting multiple sclerosis

Cost-effectiveness of teriflunomide (Aubagio ) for the treatment of adult patients with relapsing remitting multiple sclerosis Cost-effectiveness of teriflunomide (Aubagio ) for the treatment of adult patients with relapsing remitting multiple sclerosis The NCPE has issued a recommendation regarding the cost-effectiveness of teriflunomide

More information

Naltrexone Shared Care Guideline for the treatment of alcohol dependence and opioid dependance

Naltrexone Shared Care Guideline for the treatment of alcohol dependence and opioid dependance Naltrexone Shared Care Guideline for the treatment of alcohol dependence and opioid dependance Introduction Indication/Licensing information: Naltrexone is licensed for use as an additional therapy, within

More information

USE OF MARIJUANA FOR THE TREATMENT OF MULTIPLE SCLEROSIS

USE OF MARIJUANA FOR THE TREATMENT OF MULTIPLE SCLEROSIS USE OF MARIJUANA FOR THE TREATMENT OF MULTIPLE SCLEROSIS Riley Bove, MD MMSc DISCLOSURES Associate neurologist Partners MS Center Brigham and Women s Hospital Instructor Harvard Medical School Funding

More information

Fampridine (Fampyra ) in multiple sclerosis

Fampridine (Fampyra ) in multiple sclerosis Fampridine (Fampyra ) in multiple sclerosis NHS Regional Drug & Therapeutics Centre (Newcastle) March 2012 Summary Fampridine is a first-in-class oral potassium channel blocker licensed to improve walking

More information

2. Background This drug had not previously been considered by the PBAC.

2. Background This drug had not previously been considered by the PBAC. PUBLIC SUMMARY DOCUMENT Product: Ambrisentan, tablets, 5 mg and 10 mg, Volibris Sponsor: GlaxoSmithKline Australia Pty Ltd Date of PBAC Consideration: July 2009 1. Purpose of Application The submission

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This file is posted on the Bayer HealthCare Clinical Trials Registry and Results website. It is provided for patients and healthcare professionals to increase the transparency of

More information

Fatigue in MS: 2005 update B. Colombo University of Milan - HSR

Fatigue in MS: 2005 update B. Colombo University of Milan - HSR Fatigue in MS: 2005 update B. Colombo University of Milan - HSR Fatigue in MS One of the more disabling symptoms Affects about 75/90 % of the patients May be the onset symptom Transient or chronic May

More information

Dimethyl fumarate for treating relapsing remitting multiple sclerosis

Dimethyl fumarate for treating relapsing remitting multiple sclerosis NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Final appraisal determination Dimethyl fumarate for treating relapsing remitting multiple sclerosis This guidance was developed using the single technology

More information

Nalmefene for reducing alcohol consumption in people with alcohol dependence

Nalmefene for reducing alcohol consumption in people with alcohol dependence Nalmefene for reducing alcohol consumption in people with alcohol dependence Issued: November 2014 guidance.nice.org.uk/ta325 NICE has accredited the process used by the Centre for Health Technology Evaluation

More information

FREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C

FREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C FREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C SR in Combination with an ERA and/or a PDE-5 Inhibitor

More information

THE 7:16 WAS ON TIME BUT MY LEGS WERE BEHIND SCHEDULE THAT S WHEN I ASKED FOR THE WALKING PILL

THE 7:16 WAS ON TIME BUT MY LEGS WERE BEHIND SCHEDULE THAT S WHEN I ASKED FOR THE WALKING PILL THE 7:16 WAS ON TIME BUT MY LEGS WERE BEHIND SCHEDULE THAT S WHEN I ASKED FOR THE WALKING PILL See page 12 for FREE* TRIAL OFFER *Limitations and restrictions apply. Actor portrayal AMPYRA (dalfampridine)

More information

2.0 Synopsis. Vicodin CR (ABT-712) M05-765 Clinical Study Report R&D/07/095. (For National Authority Use Only) to Part of Dossier: Volume:

2.0 Synopsis. Vicodin CR (ABT-712) M05-765 Clinical Study Report R&D/07/095. (For National Authority Use Only) to Part of Dossier: Volume: 2.0 Synopsis Abbott Laboratories Name of Study Drug: Vicodin CR Name of Active Ingredient: Hydrocodone/Acetaminophen Extended Release (ABT-712) Individual Study Table Referring to Part of Dossier: Volume:

More information

Standardized cannabis in multiple sclerosis: a case report. Paul Hornby* and Manju Sharma

Standardized cannabis in multiple sclerosis: a case report. Paul Hornby* and Manju Sharma Standardized cannabis in multiple sclerosis: a case report Paul Hornby* and Manju Sharma Addresses: [S1] 1 Department of Medical Cannabis Research, The Green Cross Society of BC, 2127, Kingsway, Vancouver,

More information

SYNOPSIS. 2-Year (0.5 DB + 1.5 OL) Addendum to Clinical Study Report

SYNOPSIS. 2-Year (0.5 DB + 1.5 OL) Addendum to Clinical Study Report Name of Sponsor/Company: Bristol-Myers Squibb Name of Finished Product: Abatacept () Name of Active Ingredient: Abatacept () Individual Study Table Referring to the Dossier (For National Authority Use

More information

Medication Policy Manual. Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012

Medication Policy Manual. Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012 Medication Policy Manual Policy No: dru283 Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012 Committee Approval Date: December 12, 2014 Next Review Date: December 2015 Effective Date: January

More information

Drug-resistant MS spasticity treatment with Sativex add-on and driving ability

Drug-resistant MS spasticity treatment with Sativex add-on and driving ability Sundheds- og Forebyggelsesudvalget 2014-15 SUU Alm.del Bilag 111 Offentligt Acta Neurol Scand DOI: 10.1111/ane.12287 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd ACTA NEUROLOGICA SCANDINAVICA

More information

Teriflunomide for treating relapsing remitting multiple sclerosis

Teriflunomide for treating relapsing remitting multiple sclerosis Teriflunomide for treating relapsing remitting multiple Issued: January 2014 last modified: June 2014 guidance.nice.org.uk/ta NICE has accredited the process used by the Centre for Health Technology Evaluation

More information

Emergency Room Treatment of Psychosis

Emergency Room Treatment of Psychosis OVERVIEW The term Lewy body dementias (LBD) represents two clinical entities dementia with Lewy bodies (DLB) and Parkinson s disease dementia (PDD). While the temporal sequence of symptoms is different

More information

Many people with MS use some form of conventional medical treatment, and many people also use complementary and alternative medicine (CAM).

Many people with MS use some form of conventional medical treatment, and many people also use complementary and alternative medicine (CAM). Complementary and alternative medicine (CAM) CAM therapies can generally be divided into the following categories: Biologically based therapies (eg, dietary supplements, diets, bee venom therapy, hyperbaric

More information

Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials

Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials

More information

Cost-effectiveness of dimethyl fumarate (Tecfidera ) for the treatment of adult patients with relapsing remitting multiple sclerosis

Cost-effectiveness of dimethyl fumarate (Tecfidera ) for the treatment of adult patients with relapsing remitting multiple sclerosis Cost-effectiveness of dimethyl fumarate (Tecfidera ) for the treatment of adult patients with relapsing remitting multiple sclerosis The NCPE has issued a recommendation regarding the cost-effectiveness

More information

DEPRESSION Depression Assessment PHQ-9 Screening tool Depression treatment Treatment flow chart Medications Patient Resource

DEPRESSION Depression Assessment PHQ-9 Screening tool Depression treatment Treatment flow chart Medications Patient Resource E-Resource March, 2015 DEPRESSION Depression Assessment PHQ-9 Screening tool Depression treatment Treatment flow chart Medications Patient Resource Depression affects approximately 20% of the general population

More information

Multiple Sclerosis Ireland, September 2013. Contents Summary 2 Commentary 3 Recommendations 5 Information on MS 6 Personal testimonies 9

Multiple Sclerosis Ireland, September 2013. Contents Summary 2 Commentary 3 Recommendations 5 Information on MS 6 Personal testimonies 9 Submission to the Department of Health Consultation on Draft Misuse of Drugs (Amendment) Regulations 2013 which will amend the Misuse of Drugs Regulations, 1988 Multiple Sclerosis Ireland, September 2013

More information

teriflunomide, 14mg, film-coated tablets (Aubagio ) SMC No. (940/14) Genzyme Ltd.

teriflunomide, 14mg, film-coated tablets (Aubagio ) SMC No. (940/14) Genzyme Ltd. teriflunomide, 14mg, film-coated tablets (Aubagio ) SMC No. (940/14) Genzyme Ltd. 10 January 2014 (Issued 07 February 2014) The Scottish Medicines Consortium (SMC) has completed its assessment of the above

More information

Donepezil (Aricept ), Galantamine (Reminyl XL ), Rivastigmine (Exelon ) and Memantine (Ebixa )

Donepezil (Aricept ), Galantamine (Reminyl XL ), Rivastigmine (Exelon ) and Memantine (Ebixa ) Donepezil (Aricept ), Galantamine (Reminyl XL ), Rivastigmine (Exelon ) and Memantine (Ebixa ) ESCA: For the treatment of Alzheimer s disease. SECONDARY CARE SECTION TO BE COMPLETED BY INITIATING DOCTOR

More information

Dimethyl fumarate for treating relapsing-remitting multiple sclerosis

Dimethyl fumarate for treating relapsing-remitting multiple sclerosis Dimethyl fumarate for treating relapsing-remitting multiple Issued: August 2014 guidance.nice.org.uk/ta320 NICE has accredited the process used by the Centre for Health Technology Evaluation at NICE to

More information

Annette E. Fleckenstein, M.S., Ph.D.

Annette E. Fleckenstein, M.S., Ph.D. Annette E. Fleckenstein, M.S., Ph.D. Professor of Dentistry Deputy Director, Utah Addiction Center University of Utah http://healthsciences.utah.edu/utahaddictioncenter/ fleckenstein@hsc.utah.edu Marijuana

More information

National Hospital for Neurology and Neurosurgery. Managing Spasticity. Spasticity Service

National Hospital for Neurology and Neurosurgery. Managing Spasticity. Spasticity Service National Hospital for Neurology and Neurosurgery Managing Spasticity Spasticity Service If you would like this document in another language or format, or require the services of an interpreter please contact

More information

ALL ABOUT SPASTICITY. www.almirall.com. Solutions with you in mind

ALL ABOUT SPASTICITY. www.almirall.com. Solutions with you in mind ALL ABOUT SPASTICITY www.almirall.com Solutions with you in mind WHAT IS SPASTICITY? The muscles of the body maintain what is called normal muscle tone, a level of muscle tension that allows us to hold

More information

Which injectable medication should I take for relapsing-remitting multiple sclerosis?

Which injectable medication should I take for relapsing-remitting multiple sclerosis? Which injectable medication should I take for relapsing-remitting multiple sclerosis? A decision aid to discuss options with your doctor This decision aid is for you if you: Have multiple sclerosis Have

More information

rifaximin 550mg film-coated tablets (Targaxan ) SMC No. (893/13) Norgine Pharmaceuticals Ltd

rifaximin 550mg film-coated tablets (Targaxan ) SMC No. (893/13) Norgine Pharmaceuticals Ltd rifaximin 550mg film-coated tablets (Targaxan ) SMC No. (893/13) Norgine Pharmaceuticals Ltd 09 August 2013 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and

More information

New treatments for spasticity and other symptoms

New treatments for spasticity and other symptoms EMSP Annual Congress Brussels, 12. Mai 2011 New treatments for spasticity and other symptoms Norbert Goebels, MD Department of Neurology Heinrich-Heine-University Düsseldorf, Germany Multiple Sclerosis

More information

Donepezil, galantamine, rivastigmine (review) and memantine for the treatment of Alzheimer s disease (amended)

Donepezil, galantamine, rivastigmine (review) and memantine for the treatment of Alzheimer s disease (amended) Issue date: November 2006 (amended September 2007, August 2009) Donepezil, galantamine, rivastigmine (review) and memantine for the treatment of Alzheimer s disease (amended) Includes a review of NICE

More information

Antidepressants and suicidal thoughts and behaviour. Pharmacovigilance Working Party. January 2008

Antidepressants and suicidal thoughts and behaviour. Pharmacovigilance Working Party. January 2008 Antidepressants and suicidal thoughts and behaviour Pharmacovigilance Working Party January 2008 PhVWP PAR January 2008 Page 1/15 1. Introduction The Pharmacovigilance Working Party has on a number of

More information

Adalimumab for the treatment of psoriasis

Adalimumab for the treatment of psoriasis DOI: 10.3310/hta13suppl2/07 Health Technology Assessment 2009; Vol. 13: Suppl. 2 Adalimumab for the treatment of psoriasis D Turner, J Picot,* K Cooper and E Loveman Southampton Health Technology Assessments

More information

Novartis Gilenya FDO Program Clinical Protocol and Highlights from Prescribing Information (PI)

Novartis Gilenya FDO Program Clinical Protocol and Highlights from Prescribing Information (PI) Novartis Gilenya FDO Program Clinical Protocol and Highlights from Prescribing Information (PI) Highlights from Prescribing Information - the link to the full text PI is as follows: http://www.pharma.us.novartis.com/product/pi/pdf/gilenya.pdf

More information

Adjunctive psychosocial intervention. Conditions requiring dose reduction. Immediate, peak plasma concentration is reached within 1 hour.

Adjunctive psychosocial intervention. Conditions requiring dose reduction. Immediate, peak plasma concentration is reached within 1 hour. Shared Care Guideline for Prescription and monitoring of Naltrexone Hydrochloride in alcohol dependence Author(s)/Originator(s): (please state author name and department) Dr Daly - Consultant Psychiatrist,

More information

Dietary treatment of cachexia challenges of nutritional research in cancer patients

Dietary treatment of cachexia challenges of nutritional research in cancer patients Dietary treatment of cachexia challenges of nutritional research in cancer patients Trude R. Balstad 4th International Seminar of the PRC and EAPC RN, Amsterdam 2014 Outline Cancer cachexia Dietary treatment

More information

Before, Frank's immune cells could

Before, Frank's immune cells could Before, Frank's immune cells could barely recognize a prostate cancer cell. Now, they are focused on it. Stimulate an immune response against advanced prostate cancer Extend median survival beyond 2 years

More information

Medication Policy Manual. Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012

Medication Policy Manual. Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012 Medication Policy Manual Policy No: dru283 Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012 Committee Approval Date: December 11, 2015 Next Review Date: December 2016 Effective Date: January

More information

boceprevir 200mg capsule (Victrelis ) Treatment experienced patients SMC No. (722/11) Merck, Sharpe and Dohme Ltd

boceprevir 200mg capsule (Victrelis ) Treatment experienced patients SMC No. (722/11) Merck, Sharpe and Dohme Ltd boceprevir 200mg capsule (Victrelis ) Treatment experienced patients SMC No. (722/11) Merck, Sharpe and Dohme Ltd 09 September 2011 The Scottish Medicines Consortium (SMC) has completed its assessment

More information

TAKING THE NEXT STEP

TAKING THE NEXT STEP FOR ADULTS WITH MS TAKING THE NEXT STEP AMPYRA TREATMENT GUIDE walking better matters See the Patient Medication Guide below. About AMPYRA (dalfampridine) Extended release tablets How is AMPYRA different?

More information

A Guide to Medical Marijuana

A Guide to Medical Marijuana A Guide to Medical Marijuana Thousands of Marijuana Medicines Why Can Doctors Prescribe Only Two? By Sue Rusche President and CEO, National Families in Action April, 2014 National Families in Action has

More information

Sponsor Novartis. Generic Drug Name Secukinumab. Therapeutic Area of Trial Psoriasis. Approved Indication investigational

Sponsor Novartis. Generic Drug Name Secukinumab. Therapeutic Area of Trial Psoriasis. Approved Indication investigational Clinical Trial Results Database Page 2 Sponsor Novartis Generic Drug Name Secukinumab Therapeutic Area of Trial Psoriasis Approved Indication investigational Clinical Trial Results Database Page 3 Study

More information

Clinical pathway concept - a key to seamless care

Clinical pathway concept - a key to seamless care SECTION 5: PATIENT SAFETY AND QUALITY ASSURANCE 1 Clinical pathway concept - a key to seamless care Audrey Janoly-Dumenil, Hôpital Edouard Herriot, CHU Lyon Marie-Camille Chaumais, Hôpital Antoine Béclère,

More information

Shared Care Protocol for the Prescription of Memantine for Alzheimer s disease

Shared Care Protocol for the Prescription of Memantine for Alzheimer s disease Shared Care Protocol for the Prescription of Memantine for Alzheimer s disease 1. REFERRAL CRITERIA Patients of any age that are suspected to be suffering from moderate to severe Alzheimer s disease will

More information

Travel to Africa 2005. David V. Diamond, MD MIT Medical Department

Travel to Africa 2005. David V. Diamond, MD MIT Medical Department Travel to Africa 2005 David V. Diamond, MD MIT Medical Department 1 General Advice: Overall risks are low for diseases other than Traveler's diarrhea Preventative measures to avoid exposure to mosquito

More information

NHS ONEL and NELFT Shared Care Guidelines. Management of medications for Alzheimer s disease. Patient Name : Date of Birth: NHS No:

NHS ONEL and NELFT Shared Care Guidelines. Management of medications for Alzheimer s disease. Patient Name : Date of Birth: NHS No: NHS ONEL and NELFT Shared Care Guidelines Management of medications for Alzheimer s disease DOCUMENT TO BE SCANNED INTO ELECTRONIC RECORDS AND FILED IN NOTES Patient Name : Date of Birth: NHS No: Name

More information

Oral Zinc Supplementation as an Adjunct Therapy in the Management of Hepatic Encephalopathy: A Randomized Controlled Trial

Oral Zinc Supplementation as an Adjunct Therapy in the Management of Hepatic Encephalopathy: A Randomized Controlled Trial Oral Zinc Supplementation as an Adjunct Therapy in the Management of Hepatic Encephalopathy: A Randomized Controlled Trial Marcus R. Pereira A. Study Purpose Hepatic encephalopathy is a common complication

More information

1.0 Abstract. Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians taking HUMIRA. Keywords. Rationale and Background:

1.0 Abstract. Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians taking HUMIRA. Keywords. Rationale and Background: 1.0 Abstract Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians taking HUMIRA Keywords Rationale and Background: This abbreviated clinical study report is based on a clinical surveillance

More information

Interventions for harmful drinking and alcohol dependence

Interventions for harmful drinking and alcohol dependence Interventions for harmful drinking and alcohol dependence A NICE pathway brings together all NICE guidance, quality standards and materials to support implementation on a specific topic area. The pathways

More information

Mental health problems in people with MS: What can we do? Eli Silber Consultant Neurologist Kings College hospital

Mental health problems in people with MS: What can we do? Eli Silber Consultant Neurologist Kings College hospital Mental health problems in people with MS: What can we do? Eli Silber Consultant Neurologist Kings College hospital The emotional consequences of MS MS Population General Population Depression (Lifetime

More information

JUST THE FACTS: MARIJUANA AND MEDICINE

JUST THE FACTS: MARIJUANA AND MEDICINE Marijuana and Your Health: Just The Facts Part II JUST THE FACTS: MARIJUANA AND MEDICINE Is marijuana medicine? In short, smoked crude marijuana is not medicine. However, marijuana does have medicinal

More information

CLINICAL STUDY REPORT SYNOPSIS

CLINICAL STUDY REPORT SYNOPSIS CLINICAL STUDY REPORT SYNOPSIS Document No.: EDMS-PSDB-6511351:2.0 Name of Sponsor/Company Name of Finished Product Name of Active Ingredient(s) Protocol No.: CR002353 Johnson & Johnson Pharmaceutical

More information

Metropolitan Bureau of Investigation. Narcotics - Vice - Organized Crime

Metropolitan Bureau of Investigation. Narcotics - Vice - Organized Crime Metropolitan Bureau of Investigation Narcotics - Vice - Organized Crime METROPOLITAN BUREAU of INVESTIGATION State Attorney Ninth Judicial Circuit Orange County Sheriff s Office Orlando Police Department

More information

Benzodiazepine Detoxification and Reduction of Long term Use

Benzodiazepine Detoxification and Reduction of Long term Use Benzodiazepine Detoxification and Reduction of Long term Use Malcolm Lader 1 Model of general drug misuse and dependence. Tactical interventional options Social dimension Increasing breaking of social

More information

Committee Approval Date: December 12, 2014 Next Review Date: December 2015

Committee Approval Date: December 12, 2014 Next Review Date: December 2015 Medication Policy Manual Policy No: dru299 Topic: Tecfidera, dimethyl fumarate Date of Origin: May 16, 2013 Committee Approval Date: December 12, 2014 Next Review Date: December 2015 Effective Date: January

More information

Substance Abuse Treatment. Naltrexone for Extended-Release Injectable Suspension for Treatment of Alcohol Dependence

Substance Abuse Treatment. Naltrexone for Extended-Release Injectable Suspension for Treatment of Alcohol Dependence Spring 2007 Volume 6 Issue 1 ADVISORY News for the Treatment Field Naltrexone for Extended-Release Injectable Suspension for Treatment of Alcohol Dependence What is naltrexone for extendedrelease injectable

More information

Alcohol and Dependence

Alcohol and Dependence The facts about... Alcohol and Dependence Five key things you need to know A glass of wine with dinner, a beer after work, a cocktail in the sunshine on holiday. Alcohol makes an appearance in so many

More information

Review of Pharmacological Pain Management

Review of Pharmacological Pain Management Review of Pharmacological Pain Management CHAMP Activities are possible with generous support from The Atlantic Philanthropies and The John A. Hartford Foundation The WHO Pain Ladder The World Health Organization

More information

Summary of the risk management plan (RMP) for Cerdelga (eliglustat)

Summary of the risk management plan (RMP) for Cerdelga (eliglustat) EMA/743948/2014 Summary of the risk management plan (RMP) for Cerdelga (eliglustat) This is a summary of the risk management plan (RMP) for Cerdelga, which details the measures to be taken in order to

More information

Medical management of CHF: A New Class of Medication. Al Timothy, M.D. Cardiovascular Institute of the South

Medical management of CHF: A New Class of Medication. Al Timothy, M.D. Cardiovascular Institute of the South Medical management of CHF: A New Class of Medication Al Timothy, M.D. Cardiovascular Institute of the South Disclosures Speakers Bureau for Amgen Background Chronic systolic congestive heart failure remains

More information

Prucalopride for the treatment of chronic constipation in women

Prucalopride for the treatment of chronic constipation in women Prucalopride for the treatment of chronic constipation in Issued: December 2010 guidance.nice.org.uk/ta NICE has accredited the process used by the Centre for Health Technology Evaluation at NICE to produce

More information

placebo-controlledcontrolled double-blind, blind,

placebo-controlledcontrolled double-blind, blind, Clinical Potential of Minocycline for Depression with Psychotic Features Tsuyoshi Miyaoka Department of Psychiatry Shimane University School of Medicine Minocycline 1. Second-generation tetracycline which

More information

NeuroStar TMS Therapy Patient Guide for Treating Depression

NeuroStar TMS Therapy Patient Guide for Treating Depression NeuroStar TMS Therapy Patient Guide for Treating Depression This NeuroStar TMS Therapy Patient Guide for Treating Depression provides important safety and use information for you to consider about treating

More information

Riociguat Clinical Trial Program

Riociguat Clinical Trial Program Riociguat Clinical Trial Program Riociguat (BAY 63-2521) is an oral agent being investigated as a new approach to treat chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension

More information

Shared Care Guideline-Use of Donepezil, Galantamine, Rivastigmine and Memantine in Dementia

Shared Care Guideline-Use of Donepezil, Galantamine, Rivastigmine and Memantine in Dementia Shared Care Guideline-Use of Donepezil, Galantamine, Rivastigmine and Memantine in Dementia Version: 3.0 Ratified by: Medicines Committee Date ratified: 16 th November 2011 Name of originator/author: James

More information