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Back Pain - Gain competitive edge by targeting subpopulations

Introduction

Back pain can restrict activity and quality of everyday life and in some cases is a potentially chronic and even crippling condition. Therefore, back pain exerts a large economic impact on society. Due to the high prevalence of back pain, the condition represents a commercially attractive target to pharmaceutical companies with an interest in the pain market.

Scope

Back pain overview including definition, risk factors, epidemiology and discussion of key unmet needs.

Summary of the drug classes currently used for the treatment of back pain and an update of the latest treatment guidelines.

Evaluation of three potentially viable market entry points to access the highly prevalent back pain population.

Stakeholder opinions based on qualitative interviews with seven US and European key opinion leaders in the field of back pain.

Highlights

Despite the high prevalence of back pain, no marketed pharmacological product possesses an indication for this condition. The strategy has the potential to confer several commercial advantages, not least product differentiation. However, important clinical and regulatory hurdles lie in the path to successful implementation of this approach.

The plethora of inexpensive generic analgesics represents a sizable barrier to pharmaceutical companies hoping to either penetrate or increase their market share in the back pain sector. Targeting the narrowly defined chronic neuropathic back pain population represents one path to success for manufacturers of non-traditional analgesics.

Sales of oral products dominate the pain market and only a handful major topical patch brands are currently available. Given the conceptual benefit of applying treatment to the site of pain, marketing further patch formulations towards back pain is could be commercially viable strategy for drug delivery companies.

Reasons to Purchase

Understand the prevalence of acute and chronic back pain, including the proportion of chronic back pain attributable to neuropathic mechanisms.

Identify the key clinical unmet needs in the treatment of back pain as gauged by the insight provided by interviewed key opinion leaders.

Evaluate the potential of three strategies which companies can employ in order to increase their presence in the back pain sector of the pain market.

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY 3

CHAPTER 2 CONDITION OVERVIEW AND PATIENT POTENTIAL 8

• Introduction 9
• Anatomy of the back 9
• Definition of back pain 11
• Back pain classification 12
  • Location 13
  • Duration 13
  • Etiology 14
• Mechanism 14
  • Etiology of back pain 15
  • Back pain is a condition of many possible etiologies 15
• Risk factors 16
  • Risk factors for back pain are multi-factorial 16
  • Genetic risk factors 17
  • Individual risk factors 18
  • Environmental risk factors 20
• Epidemiology of back pain 22
  • Assessing the prevalence of back pain is fraught with methodological difficulties 22
  • Acute and chronic back pain is estimated to affect a total of 129 million adults in the seven major markets in 2009 28
  • Acute back pain is estimated to affect over 79 million adults across the seven major markets 29
  • Chronic back pain is estimated to affect 49 million adults across the seven major markets 30
  • Back pain prevalence increases with age 33
  • The prevalence rate of back pain during school age approaches that seen in adults 34
  • Back pain prevalence peaks among adults of working age 34
  • Epidemiological studies report only small gender differences in back pain prevalence 37
  • International studies lack consensus on the longitudinal prevalence of back pain 39
  • Reports of increased prevalence of back pain in recent years may be attributable to cultural factors 40
  • Although highly prevalent, key opinion leaders believe the patient presentation rate for back pain to be low 42

CHAPTER 3 DIAGNOSIS AND TREATMENT OF BACK PAIN 44

• Diagnosis of back pain 45
  • Guidelines discourage routine use of diagnostic imaging 45
  • However, some physicians continue to order unnecessary and costly imaging tests 46
  • The majority of back pain cases are classified as non-specific 49
• Key treating physicians 51
  • Primary care physicians are key prescribers of pharmacological treatments for back pain 51
  • Beyond primary care physicians, the management of back pain lacks a well-defined referral pathway 52
• Overview of current treatment options 54
  • Pharmacotherapy 54
    • Non-steroidal anti-inflammatory drugs: the cornerstone of pharmacological treatment of back pain 56
    • Opioids 57
    • Skeletal muscle relaxants 58
    • Non-traditional analgesics 59
  • Medical devices 62
    • Implantable systems 62
    • Transcutaneous electrical nerve stimulation (TENS) 64
  • Surgery 65
  • Complementary and alternative medicine 66
• Treatment guidelines for back pain 66
  • The American College of Physicians and the American Pain Society Joint Clinical Practice Guideline 67
  • Clinical guidelines for use of chronic opioid therapy in chronic non-cancer pain 68
  • European guidelines for the management of chronic non-specific low back pain 69
  • UK: NICE is expected to publish clinical guidelines in May 2009 70
• Unmet needs 72
  • Unmet need 1: More targeted treatments 73
  • Unmet need 2: Improved pain relief and control 76
  • Unmet need 3: Improved side effect and safety profile 78
  • Unmet need 4: Therapies that carry a lower risk of tolerance and dependence than opioid analgesics 81

CHAPTER 4 COMMERCIAL OPPORTUNITIES IN THE BACK PAIN MARKET 82

• Introduction 83
• The pain market is highly mature and dominated by non-branded drugs 83
• Seeking back pain as a sole indication represents a high risk strategy 85
• No marketed pharmacological product possesses an indication specifically for back pain 85
• Gaining an indication for the treatment of back pain will serve as a key product differentiator 90
• Gaining a back pain indication will enable marketing messages to become more targeted 92
• Commitment to one condition was a winning strategy for UCB's Keppra 92
• The US market offers the greatest commercial opportunity to drugs with a back pain indication due to the presence of direct-to-consumer (DTC) advertising 93
• Hurdles lie in the path to securing a back pain indication 95
• Difficulties of establishing efficacy in back pain clinical trials 96
• Tougher post-Vioxx regulatory environment in the US 99
• Targeting the neuropathic back pain population represents a more viable strategy 100
• Key opinion leaders concur that targeting treatments towards back pain subpopulations would be of benefit 100
• However, identifying subgroups of non-specific back pain patients amenable to specific drug treatments would require substantial research 102
• Seeking a neuropathic back pain indication represents a viable strategy to companies marketing non-traditional analgesics 103
• Pfizer's Lyrica has benefited from targeting neuropathic pain subtypes 103
• At present no drug is approved for the treatment of neuropathic back pain 104
• Newron's ralfinamide has the potential to become the first drug approved for the treatment of neuropathic low back pain 107
• Topical formulations 110
• Topical treatments account for a minority of pain-drug prescriptions 110
• Development of further injectable formulations and medical devices is unlikely to be met with commercial success 111
• There remains room in the market for further topical formulations 112
• Three prescription topical formulations are presently available for the treatment of pain conditions 112
• Key opinion leaders concur that topical is the preferred drug delivery method among back pain patients 115
• The US will be the most receptive market to topical treatments for back pain 118

BIBLIOGRAPHY 120

• Books and journal papers 120
• Websites 133

List of Tables 

• Table 1: Epidemiology surveys of back pain, published between 1994 and 2007 25
• Table 2: Prevalence of acute back pain in adults in the seven major markets, 2009 30
• Table 3: Prevalence of chronic back pain in adults in the seven major markets, 2009 31
• Table 4: Epidemiology surveys of neuropathic pain among patients with chronic back pain 32
• Table 5: Prevalence of neuropathic pain among adult patients with chronic back pain across the seven major markets, 2009 33
• Table 6: Epidemiology surveys of back pain among men and women, published between 1995 and 2007 38
• Table 7: Studies examining the longitudinal prevalence of back pain 40
• Table 8: Advantages and disadvantages of two implantable systems in the treatment of back pain 63
• Table 9: Key recommendations on the use of pharmacological treatments from the European guidelines for the management of chronic non-specific low back pain 70
• Table 10: Side effects and risks associated with key drug classes prescribed for back pain, 2009 78
• Table 11: Approved indications of the top 10 pain brands, 2007 86
• Table 12: Key drugs in clinical trials for back pain, 2009 88
• Table 13: Guidelines for clinical studies assessing the efficacy of drugs for the management of acute low back pain 98

List of Figures 

• Figure 1: Key regions of the spine 10
• Figure 2: Key classifications of back pain 12
• Figure 3: Key risk factors for developing back pain 17
• Figure 4: Prevalence of back pain in the adult population across the seven major markets in 2009 29
• Figure 5: Age distribution of 1-month and lifetime prevalence of back pain lasting more than 24 hours 35
• Figure 6: Red flags associated with a higher risk of serious disorders as a cause of back pain 45
• Figure 7: Use of lumbar magnetic resonance imaging (MRI) among US Medicare patients, 1994-2005 47
• Figure 8: Current drug treatment for chronic back pain, according to treating physicians in Germany, 2006 55
• Figure 9: Key recommendations of the clinical guideline for the use of chronic opioid therapy on chronic non-cancer pain 69
• Figure 10: Key unmet needs in the treatment of back pain 72
• Figure 11: Branded and unbranded sales value of the pain market across the seven major markets ($ billion), 2004-07 84
• Figure 12: Pros and cons of key strategies to penetrate the back pain market 85
• Figure 13: SWOT analysis for seeking a back pain indication 91
• Figure 14: SWOT analysis: Ralfinamide in the treatment of neuropathic low back pain 109
• Figure 15: Pain market sales volume (IMS standard units sold) by delivery method in the seven major markets, 2007 110
• Figure 16: Seven major market pain market sales value dynamics by delivery method, 2007 111
• Figure 17: Clinical advantages and disadvantages of topical administration of back pain treatments 116

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