Stakeholder Insight: Fibromyalgia - Substantial Growth Opportunity for SNRI Antidepressants

SUMMARY

Fibromyalgia is a relatively common chronic pain syndrome, affecting around2% of the population. This little understood market suffers from high unmet needboth at the level of drug research and current clinical practice.

To date,there are no drugs approved to treat fibromyalgia, and current therapiesprescribed off label, such as amitriptyline, are only partially effective atrelieving the main symptoms of the syndrome and often cause undesirable sideeffects. As such, the high demand for new drugs coupled with large (and growing)patient numbers, means that the fibromyalgia market is a prime target foremerging therapies. This Report is based on a survey of 260 primary carephysicians, surgeons, pain specialists and neurologists across the seven majorpharmaceutical markets.

Key findings and highlights

• Fibromyalgia is a common syndrome that is substantially under served bythe medical profession and the pharmaceutical industry. The challenge facinginvestors is to provide improved understanding of the biologic andphysiologic processes responsible for the symptoms, in order to developbetter pain medications that can improve quality of life.
• The biggest commercial opportunity is for manufacturers of serotonin andnoradrenaline reuptake inhibitors (SNRIs). Forest\'s SNRI milnacipran isthe closest to entering the market, although competition from Eli Lilly andWyeth can be expected in the near future.
• Companies aiming to enter the fibromyalgia market need to push regulatoryagencies to recognize the condition as a single clinical entity. Until thisis achieved, companies will be unable to gain labelling for fibromyalgia.

Reasons to buy

• Forecast product sales by understanding key aspects of fibromyalgiaepidemiology, diagnosis and treatment
• Gain a better understanding of the challenges faced by future players inthe fibromyalgia market
• Predict trends in the treatment of fibromyalgia and how to capitalize onforthcoming changes in treatment practice

TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY

1.1 Scope of the Analysis

1.2 Datamonitor insight into fibromyalgia

Fibromyalgia is a common syndrome that is substantially underserved by themedical profession and the pharmaceutical industry. The challenge facinginvestors is to provide improved understanding of the biological andphysiological processes responsible for the symptoms, in order to developbetter pain medications that can improve quality of life.

The popularity of amitriptyline among physicians for treating fibromyalgiahas paved the way for the uptake of newer antidepressants. The biggestcommercial opportunity is for manufacturers of serotonin and noradrenalinereuptake inhibitors (SNRIs). Forest's SNRI milnacipran is the closest toentering the market, although competition from Eli Lilly and Wyeth can beexpected in the near future.

Datamonitor recommends companies aiming to enter the fibromyalgia marketpush regulatory agencies to recognize the condition as a single clinicalentity. Until this is achieved companies will be unable to gain a labelingfor fibromyalgia.

1.3 Fibromyalgia Insight: methodology

CHAPTER 2 INTRODUCTION

CHAPTER 3 PATIENT POTENTIAL

3.1 Definition of fibromyalgia

3.2 Epidemiology across the seven major markets

Prevalence

Breakdown by severity

CHAPTER 4 ASSESSMENT AND TREATMENT

4.1 Diagnosis

4.2 Referral patterns

Overview

US

Japan

France

Germany

Italy

Spain

UK

4.3 Importance of therapeutic endpoints in fibromyalgia on prescribingdecisions

Overview

US

Japan

France

Germany

Italy

Spain

UK

4.4 Pharmacotherapy

Introduction

4.5 Treatment of fibromyalgia in the seven major markets

Overview

US

Japan

France

Germany

Italy

Spain

UK

4.6 R&D drugs

Pipeline overview

Milnacipran

Duloxetine

Venlafaxine

Pregabalin

4.7 Unmet needs

CHAPTER 5 APPENDIX A

5.1 Bibliography

References

Websites

5.2 Contributing experts

5.3 Physician research methodology

Introduction

Our research partners

Research objectives

Questionnaire development

Research methodology

Data processing

Quality control

5.4 Neuropathic Pain Insight Questionnaire

CHAPTER 6 APPENDIX B

6.1 About Datamonitor

About Datamonitor Healthcare

Datamonitor Healthcare's research and analysis methodologies

6.2 Datamonitor Healthcare's therapy area capabilities

About the CNS analysis team

Datamonitor Healthcare's Consulting expertise

Key therapy team members

About the Author

Disclaimer

List of Tables

Table 1: Sample size of the Fibromyalgia Insight study, 2003

Table 2: The fibromyalgia patient population across the seven majormarkets, 2003

Table 3: Fibromyalgia referral patterns across the seven major markets,2003

Table 4: Referral patterns of fibromyalgia patients in the US, 2003

Table 5: Referral patterns of fibromyalgia patients in Japan, 2003

Table 6: Referral patterns of fibromyalgia patients in France, 2003

Table 7: Referral patterns of fibromyalgia patients in Germany, 2003

Table 8: Referral patterns of fibromyalgia patients in Italy, 2003

Table 9: Referral patterns of fibromyalgia patients in Spain, 2003

Table 10: Referral patterns of fibromyalgia patients in the UK, 2003

Table 11: Importance of key therapeutic endpoints in fibromyalgiaaccording to US physicians, 2003

Table 12: Importance of key therapeutic endpoints in fibromyalgiaaccording to physicians in Japan, 2003

Table 13: Importance of key therapeutic endpoints in fibromyalgiaaccording to physicians in France, 2003

Table 14: Importance of key therapeutic endpoints in fibromyalgiaaccording to physicians in Germany, 2003

Table 15: Importance of key therapeutic endpoints in fibromyalgiaaccording to physicians in Italy, 2003

Table 16: Importance of key therapeutic endpoints in fibromyalgiaaccording to physicians in Spain, 2003

Table 17: Importance of key therapeutic endpoints in fibromyalgiaaccording to physicians in the UK, 2003

Table 18: Top ten most widely adopted first-line treatments offibromyalgia in the US, 2003

Table 19: Progression of fibromyalgia patients to second-line therapy inthe US, 2003

Table 20: Top ten most widely adopted second-line treatments offibromyalgia in the US, 2003

Table 21: Progression of fibromyalgia patients to third-line therapy inthe US, 2003

Table 22: Top ten most widely adopted third-line treatments offibromyalgia in the US, 2003

Table 23: Top ten first-line treatments of fibromyalgia in Japan, 2003

Table 24: Progression of fibromyalgia patients to second-line therapy inJapan, 2003

Table 25: Top ten most widely adopted second-line treatments offibromyalgia in Japan, 2003

Table 26: Progression of fibromyalgia patients to third-line therapy inJapan, 2003

Table 27: Top ten most widely adopted third-line treatments offibromyalgia in Japan, 2003

Table 28: Top ten first-line treatments of fibromyalgia in France, 2003

Table 29: Progression of fibromyalgia patients to second-line therapy inFrance, 2003

Table 30: Top ten most widely adopted second-line treatments offibromyalgia in France, 2003

Table 31: Progression of fibromyalgia patients to third-line therapy inFrance, 2003

Table 32: Top ten most widely adopted third-line treatments offibromyalgia in France, 2003

Table 33: Top first-line treatments of fibromyalgia in Germany, 2003

Table 34: Progression of fibromyalgia patients to second-line therapy inGermany, 2003

Table 35: Top ten most widely adopted second-line treatments offibromyalgia in Germany, 2003

Table 36: Progression of fibromyalgia patients to third-line therapy inGermany, 2003

Table 37: Top ten most widely adopted third-line treatments offibromyalgia in Germany, 2003

Table 38: Top ten first-line treatments of fibromyalgia in Italy, 2003

Table 39: Progression of fibromyalgia patients to second-line therapy inItaly, 2003

Table 40: Top ten most widely adopted second-line treatments offibromyalgia in Italy, 2003

Table 41: Progression of fibromyalgia patients to third-line therapy inItaly, 2003

Table 42: Top ten most widely adopted third-line treatments offibromyalgia in Italy, 2003

Table 43: Top ten first-line treatments of fibromyalgia in Spain, 2003

Table 44: Progression of fibromyalgia patients to second-line therapy inSpain, 2003

Table 45: Top ten most widely adopted second-line treatments offibromyalgia in Spain, 2003

Table 46: Progression of fibromyalgia patients to third-line therapy inSpain, 2003

Table 47: Top ten most widely adopted third-line treatments offibromyalgia in Spain, 2003

Table 48: Top ten first-line treatments of fibromyalgia in the UK, 2003

Table 49: Progression of fibromyalgia patients to second-line therapy inthe UK, 2003

Table 50: Top ten most widely adopted second-line treatments offibromyalgia in the UK, 2003

Table 51: Progression of fibromyalgia patients to third-line therapy inthe UK, 2003

Table 52: Top ten most widely adopted third-line treatments offibromyalgia in the UK, 2003

Table 53: R&D compounds for fibromyalgia, 2004

Table 54: Stakeholder and Multiclient Insight Studies by Therapy Area,2003

List of Figures

Figure 1: Breakdown of fibromyalgia patients by severity in the US, 2003

Figure 2: Breakdown of fibromyalgia patients by severity in Japan, 2003

Figure 4: Breakdown of fibromyalgia patients by severity in Germany, 2003

Figure 5: Breakdown of fibromyalgia patients by severity in Italy, 2003

Figure 6: Breakdown of fibromyalgia patients by severity in Spain, 2003

Figure 7: Breakdown of fibromyalgia patients by severity in the UK, 2003

Figure 8: The fibromyalgia 'tender points'

Figure 9: Importance of key therapeutic endpoints in fibromyalgia, 2003

Figure 10: Summary of fibromyalgia treatment in the US, 2003

Figure 11: Summary of fibromyalgia treatment in Japan, 2003

Figure 12: Summary of fibromyalgia treatment in France, 2003

Figure 13: Summary of fibromyalgia treatment in Germany, 2003

Figure 14: Summary of fibromyalgia treatment in Italy, 2003

Figure 15: Summary of fibromyalgia treatment in Spain, 2003

Figure 16: Summary of fibromyalgia treatment in the UK, 2003

Figure 17: Primary Research Process

Figure 18: Datamonitor's Healthcare Consultancy

Figure 19: Datamonitor Healthcare's Therapeutic Consulting capabilities