Table of Contents

Stakeholder Insight: Fibromyalgia - Substantial Growth Opportunity for SNRI Antidepressants - A detailed treatment analysis of fibromyalgia, based upon 260 interviews with primary care physicians, pain specialists, surgeons, neurologists, and opinion leading physicians from the seven major pharmaceutical markets

Product Code: DMHC2001

Publication Date: 19-Mar-2004

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Overview

Introduction

Fibromyalgia is a relatively common chronic pain syndrome, affecting around 2% of the population. This little understood market suffers from high unmet need both at the level of drug research and current clinical practice. Several leading industry players, including Pfizer, Eli Lilly, and Wyeth, have expressed an interest in this niche thus highlighting the commercial opportunity it offers.

Scope

· Quantitative treatment data from over 260 physicians from the US, Japan, France, Germany, Italy, Spain and the UK

· Analysis of epidemiology, assessment and referral patterns, first- to third-line treatments, and unmet market needs

· Discussion of the R&D drug pipeline for fibromyalgia, including analysis of duloxetine, pregabalin, and milnacipran

· Coverage of the hot topics including the potential of SNRI antidepressants and the need to push regulatory agencies to recognize fibromyalgia

Highlights

Fibromyalgia is a common syndrome that is substantially under served by the medical profession and the pharmaceutical industry. The challenge facing investors is to provide improved understanding of the biologic and physiologic processes responsible for the symptoms, in order to develop better pain medications that can improve quality of life.

The biggest commercial opportunity is for manufacturers of serotonin and noradrenaline reuptake inhibitors (SNRIs). Forest's SNRI milnacipran is the closest to entering the market, although competition from Eli Lilly and Wyeth can be expected in the near future.

Companies aiming to enter the fibromyalgia market need to push regulatory agencies to recognize the condition as a single clinical entity. Until this is achieved, companies will be unable to gain labeling for fibromyalgia.

Reasons to Purchase

· Forecast product sales by understanding key aspects of fibromyalgia epidemiology, diagnosis, and treatment

· Gain a better understanding of the challenges faced by future players in the fibromyalgia market

· Predict trends in the treatment of fibromyalgia and how to capitalize on forthcoming changes in treatment practice

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CHAPTER 1 EXECUTIVE SUMMARY	3
1.1 Scope of the Analysis	3
1.2 Datamonitor insight into fibromyalgia	3
Fibromyalgia is a common syndrome that is substantially underserved by the medical profession and the pharmaceutical industry. The challenge facing investors is to provide improved understanding of the biological and physiological processes responsible for the symptoms, in order to develop better pain medications that can improve quality of life.	4
The popularity of amitriptyline among physicians for treating fibromyalgia has paved the way for the uptake of newer antidepressants. The biggest commercial opportunity is for manufacturers of serotonin and noradrenaline reuptake inhibitors (SNRIs). Forest's SNRI milnacipran is the closest to entering the market, although competition from Eli Lilly and Wyeth can be expected in the near future.	5
Datamonitor recommends companies aiming to enter the fibromyalgia market push regulatory agencies to recognize the condition as a single clinical entity. Until this is achieved companies will be unable to gain a labeling for fibromyalgia.	6
1.3 Fibromyalgia Insight: methodology	7
TABLE OF CONTENTS	9
CHAPTER 2 INTRODUCTION	16
CHAPTER 3 PATIENT POTENTIAL	17
3.1 Definition of fibromyalgia	17
3.2 Epidemiology across the seven major markets	18
Prevalence	18
Breakdown by severity	19
CHAPTER 4 ASSESSMENT AND TREATMENT	24
4.1 Diagnosis	24
4.2 Referral patterns	26
Overview	26
US	26
Japan	27
France	28
Germany	29
Italy	30
Spain	31
UK	32
4.3 Importance of therapeutic endpoints in fibromyalgia on prescribing decisions	33
Overview	33
US	34
Japan	35
France	36
Germany	36
Italy	38
Spain	38
UK	39
4.4 Pharmacotherapy	40
Introduction	40
4.5 Treatment of fibromyalgia in the seven major markets	41
Overview	41
US	45
Japan	49
France	53
Germany	58
Italy	62
Spain	67
UK	71
4.6 R&D drugs	75
Pipeline overview	75
Milnacipran	76
Duloxetine	76
Venlafaxine	77
Pregabalin	78
4.7 Unmet needs	79
CHAPTER 5 APPENDIX A	81
5.1 Bibliography	81
References	81
Websites	85
5.2 Contributing experts	86
5.3 Physician research methodology	89
Introduction	89
Our research partners	91
Research objectives	92
Questionnaire development	94
Research methodology	94
Data processing	97
Quality control	97
5.4 Neuropathic Pain Insight Questionnaire	97
CHAPTER 6 APPENDIX B	104
6.1 About Datamonitor	104
About Datamonitor Healthcare	104
Datamonitor Healthcare's research and analysis methodologies	105
6.2 Datamonitor Healthcare's therapy area capabilities	105
About the CNS analysis team	106
Datamonitor Healthcare's Consulting expertise	107
Key therapy team members	108
About the Author	109
Disclaimer	111
List of Tables
Table 1: Sample size of the Fibromyalgia Insight study, 2003	7
Table 2: The fibromyalgia patient population across the seven major markets, 2003	19
Table 3: Fibromyalgia referral patterns across the seven major markets, 2003	26
Table 4: Referral patterns of fibromyalgia patients in the US, 2003	27
Table 5: Referral patterns of fibromyalgia patients in Japan, 2003	28
Table 6: Referral patterns of fibromyalgia patients in France, 2003	28
Table 7: Referral patterns of fibromyalgia patients in Germany, 2003	29
Table 8: Referral patterns of fibromyalgia patients in Italy, 2003	30
Table 9: Referral patterns of fibromyalgia patients in Spain, 2003	31
Table 10: Referral patterns of fibromyalgia patients in the UK, 2003	32
Table 11: Importance of key therapeutic endpoints in fibromyalgia according to US physicians, 2003	34
Table 12: Importance of key therapeutic endpoints in fibromyalgia according to physicians in Japan, 2003	35
Table 13: Importance of key therapeutic endpoints in fibromyalgia according to physicians in France, 2003	36
Table 14: Importance of key therapeutic endpoints in fibromyalgia according to physicians in Germany, 2003	37
Table 15: Importance of key therapeutic endpoints in fibromyalgia according to physicians in Italy, 2003	38
Table 16: Importance of key therapeutic endpoints in fibromyalgia according to physicians in Spain, 2003	39
Table 17: Importance of key therapeutic endpoints in fibromyalgia according to physicians in the UK, 2003	40
Table 18: Top ten most widely adopted first-line treatments of fibromyalgia in the US, 2003	47
Table 19: Progression of fibromyalgia patients to second-line therapy in the US, 2003	47
Table 20: Top ten most widely adopted second-line treatments of fibromyalgia in the US, 2003	48
Table 21: Progression of fibromyalgia patients to third-line therapy in the US, 2003	48
Table 22: Top ten most widely adopted third-line treatments of fibromyalgia in the US, 2003	49
Table 23: Top ten first-line treatments of fibromyalgia in Japan, 2003	50
Table 24: Progression of fibromyalgia patients to second-line therapy in Japan, 2003	51
Table 25: Top ten most widely adopted second-line treatments of fibromyalgia in Japan, 2003	51
Table 26: Progression of fibromyalgia patients to third-line therapy in Japan, 2003	52
Table 27: Top ten most widely adopted third-line treatments of fibromyalgia in Japan, 2003	52
Table 28: Top ten first-line treatments of fibromyalgia in France, 2003	55
Table 29: Progression of fibromyalgia patients to second-line therapy in France, 2003	56
Table 30: Top ten most widely adopted second-line treatments of fibromyalgia in France, 2003	56
Table 31: Progression of fibromyalgia patients to third-line therapy in France, 2003	57
Table 32: Top ten most widely adopted third-line treatments of fibromyalgia in France, 2003	57
Table 33: Top first-line treatments of fibromyalgia in Germany, 2003	59
Table 34: Progression of fibromyalgia patients to second-line therapy in Germany, 2003	60
Table 35: Top ten most widely adopted second-line treatments of fibromyalgia in Germany, 2003	60
Table 36: Progression of fibromyalgia patients to third-line therapy in Germany, 2003	61
Table 37: Top ten most widely adopted third-line treatments of fibromyalgia in Germany, 2003	61
Table 38: Top ten first-line treatments of fibromyalgia in Italy, 2003	64
Table 39: Progression of fibromyalgia patients to second-line therapy in Italy, 2003	64
Table 40: Top ten most widely adopted second-line treatments of fibromyalgia in Italy, 2003	65
Table 41: Progression of fibromyalgia patients to third-line therapy in Italy, 2003	66
Table 42: Top ten most widely adopted third-line treatments of fibromyalgia in Italy, 2003	66
Table 43: Top ten first-line treatments of fibromyalgia in Spain, 2003	68
Table 44: Progression of fibromyalgia patients to second-line therapy in Spain, 2003	69
Table 45: Top ten most widely adopted second-line treatments of fibromyalgia in Spain, 2003	69
Table 46: Progression of fibromyalgia patients to third-line therapy in Spain, 2003	70
Table 47: Top ten most widely adopted third-line treatments of fibromyalgia in Spain, 2003	70
Table 48: Top ten first-line treatments of fibromyalgia in the UK, 2003	72
Table 49: Progression of fibromyalgia patients to second-line therapy in the UK, 2003	73
Table 50: Top ten most widely adopted second-line treatments of fibromyalgia in the UK, 2003	73
Table 51: Progression of fibromyalgia patients to third-line therapy in the UK, 2003	74
Table 52: Top ten most widely adopted third-line treatments of fibromyalgia in the UK, 2003	74
Table 53: R&D compounds for fibromyalgia, 2004	75
Table 54: Stakeholder and Multiclient Insight Studies by Therapy Area, 2003	90
List of Figures
Figure 1: Breakdown of fibromyalgia patients by severity in the US, 2003	20
Figure 2: Breakdown of fibromyalgia patients by severity in Japan, 2003	21
Figure 4: Breakdown of fibromyalgia patients by severity in Germany, 2003	21
Figure 5: Breakdown of fibromyalgia patients by severity in Italy, 2003	22
Figure 6: Breakdown of fibromyalgia patients by severity in Spain, 2003	22
Figure 7: Breakdown of fibromyalgia patients by severity in the UK, 2003	23
Figure 8: The fibromyalgia 'tender points'	24
Figure 9: Importance of key therapeutic endpoints in fibromyalgia, 2003	33
Figure 10: Summary of fibromyalgia treatment in the US, 2003	46
Figure 11: Summary of fibromyalgia treatment in Japan, 2003	50
Figure 12: Summary of fibromyalgia treatment in France, 2003	53
Figure 13: Summary of fibromyalgia treatment in Germany, 2003	58
Figure 14: Summary of fibromyalgia treatment in Italy, 2003	62
Figure 15: Summary of fibromyalgia treatment in Spain, 2003	67
Figure 16: Summary of fibromyalgia treatment in the UK, 2003	71
Figure 17: Primary Research Process	90
Figure 18: Datamonitor's Healthcare Consultancy	107
Figure 19: Datamonitor Healthcare's Therapeutic Consulting capabilities	108

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