Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- Datamonitor' s therapeutic area studies comprise thefollowing features:
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the fibromyalgia market
- Key metrics
- Datamonitor Pipeline Assessment Summary
- Contributing experts
- CHAPTER 2 DISEASE OVERVIEW
- Definition and etiology
- The cause and underlying mechanisms of fibromyalgia remainunknown
- Research finds various chemical imbalances in patients
- Comorbidities
- There are significant overlaps with other conditions
- Epidemiology of fibromyalgia
- Prevalence and incidence
- Fibromyalgia is around seven times more common in womenthan men and
increases with age
- Experts and patient groups believe fibromyalgia is morecommon
- Diagnosis and treatment rates
- Over half of the fibromyalgia population remainundiagnosed
- Nearly all diagnosed patients receive drug therapy of somesort
- Market sizing calculations
- Clinical unmet needs
- Need for a better understanding of disease etiology andpathophysiology
- Need to improve pain reduction and control
- Need to reduce sleep disturbances
- CHAPTER 3 CURRENT TREATMENT CONTROVERSIES
- Pharmacological treatment - review of published clinicaltrial data
- Antidepressants
- Tricyclic antidepressants (TCAs)
- Serotonin and noradrenaline reuptake inhibitors
- Selective serotonin reuptake inhibitors
- Analgesics
- Anticonvulsants
- Alpha 2 delta antagonists
- Hormones
- Other medications
- Treatment guidelines
- US guidelines - the 2004 American Pain Society Guidelineswill soon be
outdated
- APS guidelines developed by an interdisciplinary panel of13 pain
management experts
- APS guidelines recommend physicians start patients with aTCA or
cyclobenzaprine
- New guidelines need to include new possible first-lineoptions
- European guidelines - EULAR evidence-based guidelines duein mid to
late 2007
- Objectives - to provide evidence-based recommendations forthe
treatment of fibromyalgia
- Methodology - developed by a multidisciplinaryfibromyalgia task
force representing 11 European countries
- Results - 145 pharmacologic and non-pharmacologic studieswere
evaluated
- Conclusion - Lyrica, Cymbalta and milnacipran arerecommended
therapies
- Datamonitor' s physician survey
- Referral patterns - rheumatologists are key targetphysicians
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- Prescribing patterns - physicians adopt a ' trial anderror' approach
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- CHAPTER 4 ASSESSMENT CRITERIA AND CLINICAL TRIAL DESIGN
- Assessment criteria
- American College of Rheumatology (1990) research criteriafor
fibromyalgia
- 1. History of widespread pain has been present for atleast 3 months
- 2. Pain in 11 of 18 tender point sites on digitalpalpation
- Clinical trial design
- Limitations of previous clinical trials in fibromyalgia
- Current FDA requirements for fibromyalgia claims
- Trials need to show improvements in both pain scores andfunction
- The FDA will require more mechanism-based outcomes as moreis known
about the disease
- OMERACT aims to standardize fibromyalgia endpointrequirements and
measures
- Agencies will review their clinical trial requirementsbased on
OMERACT findings
- Function endpoints and measures will be assessed
- CHAPTER 5 PIPELINE ANALYSIS AND FORECASTS
- Pipeline overview
- Pipeline mainly consists of drugs indicated for other CNSindications
- Eli Lilly and Pfizer in race to be first to market
- Market will expand rapidly following drug approvals
- A defined regulatory pathway will attract future investors
- Innovative early stage pipeline
- Opinion leaders are encouraged by dopamine modulators
- Comparative forecasts
- Comparative Datamonitor drug assessment summaries
- Key late-stage R&D product profiles
- Lyrica (pregabalin)
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Forecasts to 2016
- Datamonitor drug assessment summary
- Cymbalta (duloxetine)
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Forecasts to 2016
- Datamonitor drug assessment summary
- Milnacipran
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Forecasts to 2016
- Datamonitor drug assessment summary
- Other pipeline drugs
- Desvenlafaxine (Pristiq)
- Sodium oxybate (Xyrem)
- Lacosamide
- Rotigotine (Neupro)
- Reboxetine
- Radafaxine
- Eszopiclone (Lunesta)
- Neurotropin
- Ibutamoren mesylate (MK-0677)
- Interferon-alpha (buccal lozenge)
- Tropisetron (Navoban)
- Buspirone (transdermal spray)
- Casopitant
- CR-3124
- AD-337
- Eplivanserin
- NC-003
- CHAPTER 6 INCREASING FIBROMYALGIA MARKET OPPORTUNITIES
- Summary of market opportunities
- Improving public awareness
- There are regional variations in fibromyalgia awareness
- Current information available to the public is of mixedquality
- DTC advertising will play a big part in increasing USpublic awareness
- Fibromyalgia patient groups and associations
- The National Fibromyalgia Association is considered themost
influential US group
- Recruitment through patient group websites can bebeneficial
- Educating primary care physicians
- Supporting education initiatives is beneficial
- Combination therapy
- Opinion leaders predict combination therapy will becommonplace
- Combination of Lyrica with an antidepressant or a sleepaid will be
popular
- BIBLIOGRAPHY
- Journal articles
- Websites
- APPENDIX
- Methodology
- Datamonitor forecast methodology
- Market sizing
- Product forecasts
- Definition of a standard unit
- Datamonitor drug assessment summary
- Contributing experts
- About Datamonitor
- Datamonitor Healthcare' s research and analysismethodologies
- Datamonitor Healthcare' s therapy area capabilities
- Disclaimer
- List of Tables
- Table 1: Forecast sales of key pipeline products forfibromyalgia in
the US and 5EU ($m), 2006-2016
- Table 2: Prevalence of symptoms in fibromyalgia patients
- Table 3: Key fibromyalgia epidemiology study results,1995-2006
- Table 4: Prevalence of fibromyalgia across the sevenmajor markets, 2007
- Table 5: Fibromyalgia prevalence as quoted by variousfibromyalgia
organizations/associations, 2007
- Table 6: The total fibromyalgia market value across thesix major
markets, 2003-05
- Table 7: Stepwise fibromyalgia management as recommendedby the 2004
APS treatment guidelines
- Table 8: Summary of findings from pharmacologicalstudies in
fibromyalgia according to Arnold (2006)
- Table 9: Fibromyalgia referral patterns across the sevenmajor markets,
2003
- Table 10: Comparison of three late-stage fibromyalgiaclinical trial
designs
- Table 11: Randomized controlled trials of pregabalin,milnacipran, and
duloxetine in fibromyalgia
- Table 12: Pipeline drugs in clinical development forfibromyalgia, 2007
- Table 13: Lyrica: key facts
- Table 14: Baseline characteristic of patients* enrolledin the Crofford
et al. (2005) pregabalin trial
- Table 15: Key events, approval and launch datesimpacting Lyrica
revenue forecasts for fibromyalgia in the US and 5EU,2007-2016
- Table 16: Cymbalta: key facts
- Table 17: Results of the Arnold et al. (2005) duloxetinetrial
- Table 18: Key events, approval and launch datesimpacting Cymbalta
revenue forecasts for fibromyalgia in the US and 5EU,2007-2016
- Table 19: Milnacipran: key facts
- Table 20: Key events, approval and launch datesimpacting milnacipran
revenue forecasts for fibromyalgia in the US and5EU, 2007-2016
- Table 21: Weightings of research and clinical factorsused for pipeline
drug assessment
- Table 22: Weightings of commercial factors used forpipeline drug
assessment
- List of Figures
- Figure 1: Datamonitor' s competitive positioning analysisfor Cymbalta,
Lyrica and milnacipran in the fibromyalgia market, 2007-2016
- Figure 2: Summary of fibromyalgia treatment in the US,2003
- Figure 3: Summary of fibromyalgia treatment in Japan,2003
- Figure 4: Summary of fibromyalgia treatment in France,2003
- Figure 5: Summary of fibromyalgia treatment in Germany,2003
- Figure 6: Summary of fibromyalgia treatment in Italy,2003
- Figure 7: Summary of fibromyalgia treatment in Spain,2003
- Figure 8: Summary of fibromyalgia treatment in the UK,2003
- Figure 9: The fibromyalgia ' tender points'
- Figure 10: Datamonitor' s comparative forecast of totalUS and 5EU sales
of Cymbalta, Lyrica and milnacipran for fibromyalgia($m), 2007-2016
- Figure 11: Datamonitor' s competitive positioninganalysis for Cymbalta,
Lyrica and milnacipran in the fibromyalgia market,2007-2016
- Figure 12: SWOT analysis of Lyrica in the fibromyalgiamarket, 2007
- Figure 13: Diagram of patient flow in the Crofford etal. (2005)
pregabalin trial
- Figure 14: Datamonitor' s total US and 5EU forecast salesof Lyrica for
fibromyalgia ($m), 2006-2016
- Figure 15: Datamonitor' s competitive positioninganalysis for Lyrica in
the US and 5EU fibromyalgia market, 2007-2016
- Figure 16: SWOT analysis of Cymbalta in the fibromyalgiamarket, 2007
- Figure 17: Diagram of patient flow in the Arnold et al.(2005)
duloxetine trial
- Figure 18: Cymbalta home page, 2007
- Figure 19: Datamonitor' s total US and 5EU forecast salesof Cymbalta
for fibromyalgia ($m), 2006-2016
- Figure 20: Datamonitor' s competitive positioninganalysis for Cymbalta
in the US and 5EU for fibromyalgia market, 2007-2016
- Figure 21: SWOT analysis of milnacipran in thefibromyalgia market, 2007
- Figure 22: Diagram of patient flow in the Vitton et al.(2004)
milnacipran trial
- Figure 23: Datamonitor' s total US and 5EU forecast salesof milnacipran
for fibromyalgia ($m), 2006-2016
- Figure 24: Datamonitor' s competitive positioninganalysis for
milnacipran in the US and 5EU fibromyalgia market, 2007-2016
- Figure 25: The Forest/Cypress sponsored FibromyalgiaResource Center
homepage, 2007
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