This report presents a comprehensive update on emerging drug candidates for neuropathic pain, (NP) together with the findings of global survey on current treatment practices in the clinic, following the participation of more than 350 physicians worldwide. The global prevalence of NP is unknown; however, recent studies suggest levels of 3-10%. In a 2009 study by Biopharm Reports involving more than 350 physicians, NP was linked to 75 underlying conditions.
Part 1. Today, drugs used to treat NP drugs include more than 60 agents across 20 drug classes. Many of these drugs, such as the anticonvulsants and antidepressants, were developed for other indications, but have utility in the treatment of NP, albeit it in increasingly complex combinations. Part 1 of this report presents a comprehensive update on emerging drug candidates for NP. The current development pipeline shows just 11 Phase III candidates, three of which are based on new or novel drug targeting mechanisms for NP. Phase II however shows a very different picture, with 32 candidates, 20 (63%) of which are based on new or novel mechanisms. Overall, of the 85 pipeline candidates between Phase III and preclinical development, 33 (39%) represent new or novel mechanisms. The drug pipeline is also showing increasing convergence in the targeting strategies that pharmaceutical companies are developing, to combat NP.
Part 2 of this report presents the findings of a global survey on current therapeutic approaches to the treatment of Neuropathic Pain (NP). These findings were made following the participation of more than 350 physicians, who provided details of their treatments and prescribing practices. NP is highly individual in its presentation, level, underlying pathology and response to therapy. For some patients, available therapies give satisfactory pain control. For many others, treatments are poor or do not work at all. Therapeutic options include up to 20 drug classes, which are commonly prescribed in combinations tailored to individual patient needs. Interventional treatments, such as peripheral nerve block and transcutaneous electrical nerve stimulation, are also used as physicians seek other approaches to treating NP. This background, the individual nature of NP and the drug (or drug combination) options used to treat patients, has created a complex therapeutic picture.
In a therapeutic field where treatments are often unsatisfactory, physicians seek to extent their understanding of NP in an effort to define needs and limitations. Knowledge in these areas is also important to drug developers, who seek a better understanding of patient needs and outcomes as part of their own efforts to develop more effective therapies. To meet interest in these areas, Biopharm Reports has conducted an in-depth global survey on current treatments and drug prescribing practices, relating to NP. This survey involved the participation of more than 350 physicians and clinical centres in 56 countries. As part of this study, pain physicians were asked to described current limitations relating to the treatment of neuropathic pain. This report presents an an analysis of these findings. The report includes:
1) Comprehensive details of current treatments for NP, provided by more than 330 clinics in 56 countries
2) In-depth information relevant to markets and opportunities in the NP field
3) 98% of participants are practicing physicians, working in specialised areas of pain treatment. Of these, 78% described themselves as specialists in pain treatment
4) Leading participant countries were USA, Canada, UK, Australia, Denmark, France, Brazil, Germany, Netherlands and Belgium
5) 74% of the clinical centres participating in this study were hospital pain departments, specialised pain practices or private pain clinics. Detailed information on the use of specific drug classes including tricyclic antidepressants, SSRIs, SNRIs, anticonvulsants, sodium channel blockers, opioids, NSAIDS, cannabinoids and Capsaicin
6) Physicians have provided detailed feedback on the underlying pathologies associated with NP, seen in their patients
7) Comprehensive information on the most frequently prescribed drugs from nine drugs classes, including drug combinations, for the treatment of NP. Biopharm Reports believes this provides the most comprehensive and up-to-date review and analysis in this area currently available
8) A detailed analysis of interventional methods used for the treatment of NP (e.g. peripheral nerve block, TENS)
9) An assessment of average levels of pain relief achieved in the treatment of NP, in relation to 12 underlying conditions
10) Informative views of participating physicians on current limitations, challenges and issues relating to the treatment of NP
Executive Summary
Chapter 1 Neuropathic Pain: Therapeutic background - 19
1.1 Background
1.2 This Report
Chapter 2 Neuropathic Pain: Approved Drugs - 24
2.1 Approved Drugs
Chapter 3 Neuropathic Pain: Phase III Candidates - 34
3.1 Phase III Candidates
Chapter 4 Neuropathic Pain: Phase II Pipeline - 39
4.1 Phase II Candidates
Chapter 5 Neuropathic Pain: Phase I & Preclinical Candidates - 49
5.1 Phase I
5.2 Preclinical Candidates
Chapter 6 Neuropathic Pain: Pipeline Discussion - 59
6.1 Pipeline Discussion
6.1.1 Phase III
6.1.2 Phase II
6.1.3 Phase I
6.1.4 Preclinical
Chapter 7 Neuropathic Pain: Treatments and Prescribing
Practices - Global Survey - 63
7.1 NP Global Therapy Study
7.2 Conduct
7.3 Study questions
Chapter 8 Neuropathic Pain: Treatments and Prescribing Practices
Survey Participants - 69
8.1 Overview
8.2 Findings
Chapter 9 Neuropathic Pain Treatments and Prescribing Practices
Interventional Treatments - 75
9.1 Overview
9.2 Findings
Chapter 10 Neuropathic Pain: Treatments and Prescribing Practices
Underlying Diagnoses - 78
10.1 Overview
10.2 Findings
10.3 Other Conditions
Chapter 11 Neuropathic Pain Treatments and Prescribing Practices
Single or Multiple Drugs - 88
11.1 Overview
11.2 Findings
Chapter 12 Neuropathic Pain Treatments and Prescribing Practices
Drug Classes Used - 93
12.1 Overview
12.2 Findings
Chapter 13 Neuropathic Pain Treatments and Prescribing Practices
Tricyclic Antidepressants - 100
13.1 Overview
13.2 Findings
Chapter 14 Neuropathic Pain Treatments and Prescribing Practices
Selective Serotonin Reuptake Inhibitors - 103
14.1 Overview
14.2 Findings
Chapter 15 Neuropathic Pain Treatments and Prescribing Practices
Serotonin-Noradrenalin Reuptake Inhibitors - 106
15.1 Overview
15.2 Findings
Chapter 16Neuropathic Pain Treatments and Prescribing Practices
Survey Anticonvulsants - 109
16.1 Overview
16.2 Overview
Chapter 17Neuropathic Pain Treatments and Prescribing Practices
Sodium Channel Blockers - 112
17.1 Overview
17.2 Findings
Chapter 18 Neuropathic Pain Treatments and Prescribing Practices
Opioids - 115
18.1 Overview
18.2 Findings
Chapter 19Neuropathic Pain Treatments and Prescribing Practices
Non-Steroidal Anti-inflammatory Drugs - 118
19.1 Overview
19.2 Findings
Chapter 20 Neuropathic Pain Treatments and Prescribing Practices
Drug Combinations - 121
20.1 Overview
20.2 Findings
Chapter 21 Neuropathic Pain Treatments and Prescribing Practices
Pain Relief - 133
21.1 Overview
22.2 Findings
Chapter 22Neuropathic Pain Treatments and Prescribing Practices
Interventional Treatments - 143
22.1 Overview
22.2 Findings
22.3 Numbers of Physicians using Interventional Treatments
22.4 Mean Percentage of Physicians using Interventional Treatments
22.5 Other Interventional Treatments
Chapter 23 Neuropathic Pain Treatments and Prescribing Practices
Survey Discussion - 150
23.1 Discussion
Chapter 24 Neuropathic Pain Treatments and Prescribing Practices
Survey Participants - 154
Table 24.1 Study participants
Chapter 25 Neuropathic PainTreatments and Prescribing Practices
Appendix 1 - 166
25.1 Treatment Limitations
Figures
Figure 1.1 Average drug class prescribing practices in the treatment of Neuropathic Pain
Figure 1.2 Numbers of drug used in combination to treat NP.
Figure 1.3 Most frequently used drug class combinations for the treatment of NP
Figure 1.4 General limitations and issues associated with the treatment of neuropathic pain.
Figure 6.1 The numbers of drug classes Approved or in development for the treatment of Neuropathic Pain
Figure 6.2 The numbers of Approved and pipeline drug candidates for the treatment of Neuropathic Pain
Figure 8.1 Participant Countries
Figure 8.2 Participant Organisations
Figure 8.3 Participant Physicians
Figure 9.1 The use of interventional treatments by participating physicians
Figure 10.1 The percentage of physicians indicating that 20% or more of their patients’ Neuropathic Pain is associated with the diagnoses indicated
Figure 10.2 Mean percentage of patients with Neuropathic Pain in relation to specific underlying conditions
Figure 10.3 Neuropathic Pain in patients associated with Diabetes
Figure 10.4 Neuropathic Pain in patients associated with cancer radiotherapy or chemotherapy
Figure 10.5 Neuropathic Pain in patients post general surgery
Figure 10.6 Neuropathic Pain in patients with Trigeminal Neuralgia
Figure 10.7 Neuropathic Pain in patients with viral infection
Figure 10.8 Neuropathic Pain in patients with injury or trauma
Figure 10.9 Neuropathic Pain in patients post back surgery
Figure 10.10 Neuropathic Pain in patients with primary back problems
Figure 10.11 Neuropathic Pain in patients with Complex Regional Pain Syndrome (CRPS)
Figure 10.12 Neuropathic Pain in patients with Multiple Sclerosis
Figure 10.13 Neuropathic Pain in patients with Central Pain
Figure 10.14 Neuropathic Pain in patients with Arthritis
Figure 10.15 Neuropathic Pain in patients with other conditions
Figure 11.1 Single drug use in the treatment of Neuropathic Pain
Figure 11.2 Two drugs used in the treatment of Neuropathic Pain
Figure 11.3 Three drugs used in the treatment of Neuropathic Pain
Figure 11.4 More than three drugs used in the treatment of Neuropathic Pain
Figure 11.5 Mean drug regimens in the treatment of Neuropathic Pain
Figure 12.1 Percentage of physicians prescribing the drug classes indicated, to more than 20% of their patients
Figure 12.2 The use of Tricyclic Antidepressants in the treatment of Neuropathic Pain
Figure 12.3 The use of Selective Serotonin Reuptake Inhibitors (SSRIs) in the treatment of Neuropathic Pain
Figure 12.4 The use of Serotonin-Noradrenalin Reuptake Inhibitors (SNRIs) in the treatment of Neuropathic Pain
Figure 12.5 The use of Anticonvulsants in the treatment of Neuropathic Pain
Figure 12.6 The use of Sodium Channel Blockers in the treatment of Neuropathic Pain
Figure 12.7 The use of Opioids in the treatment of Neuropathic Pain
Figure 12.8 The use of Non-Steroidal Anti-inflammatory Drugs (NSAIDs) in the treatment of Neuropathic Pain
Figure 12.9 The use of Cannabinoids in the treatment of Neuropathic Pain
Figure 12.10 The use of Capsaicin in the treatment of Neuropathic Pain
Figure 12.11 Average drug class prescribing practices in the treatment of Neuropathic Pain
Figure 13.1 Most frequently prescribed Tricyclic Antidepressants in the treatment of Neuropathic Pain
Figure 13.2 Second most frequently prescribed tricyclic antidepressants in the treatment of Neuropathic Pain
Figure 13.3 Third most frequently prescribed tricyclic antidepressants in the treatment of Neuropathic Pain
Figure 14.1 Most frequently prescribed Selective Serotonin Reuptake Inhibitors (SSRIs) in the treatment of Neuropathic Pain
Figure 14.2 Second most frequently prescribed Selective Serotonin Reuptake Inhibitors (SSRIs) in the treatment of Neuropathic Pain
Figure 14.3 Third most frequently prescribed Selective Serotonin Reuptake Inhibitors (SSRIs) in the treatment of Neuropathic Pain
Figure 15.1 Most frequently prescribed Serotonin-Noradrenalin Reuptake Inhibitors (SNRIs) in the treatment of Neuropathic Pain
Figure 15.2 Second most frequently prescribed Serotonin-Noradrenalin Reuptake Inhibitors (SNRIs) in the treatment of Neuropathic
Figure 15.3 Third most frequently prescribed Serotonin-Noradrenalin Reuptake Inhibitors (SNRIs) in the treatment of Neuropathic
Figure 16.1 Most frequently prescribed Anticonvulsants in the treatment of Neuropathic Pain
Figure 16.2 Second most frequently prescribed Anticonvulsants in the treatment of Neuropathic Pain
Figure 16.3 Third most frequently prescribed Anticonvulsants in the treatment of Neuropathic Pain
Figure 17.1 Most frequently prescribed Sodium Channel Blockers in the treatment of Neuropathic Pain
Figure 17.2 Second most frequently prescribed Sodium Channel Blockers in the treatment of Neuropathic Pain
Figure 17.3 Third most frequently prescribed Sodium Channel Blockers in the treatment of Neuropathic Pain
Figure 18.1 Most frequently prescribed Opioids in the treatment of Neuropathic Pain
Figure 18.2 Second most frequently prescribed Opioids in the treatment of Neuropathic Pain
Figure 18.3 Third most frequently prescribed Opioids in the treatment of Neuropathic Pain
Figure 19.1 Most frequently prescribed Non-Steroidal Anti-Inflammatory Drugs in the treatment of Neuropathic Pain
Figure 19.2 Second most frequently prescribed Non-Steroidal Anti-Inflammatory Drugs in the treatment of Neuropathic Pain
Figure 19.3 Third most frequently prescribed Non-Steroidal Anti-Inflammatory Drugs in the treatment of Neuropathic Pain
Figure 20.1 Most frequently used drug class combinations for the treatment of neuropathic pain.
Figure 20.2 The Most frequently numbers of drugs used in the treatment of Neuropathic Pain.
Figure 20.3 Second most frequently used drug class combinations for the treatment of Neuropathic Pain.
Figure 20.4 Second most frequently used drug numbers In the treatment of Neuropathic Pain
Figure 20.5 Third most frequently used drug class combinations for the treatment of Neuropathic Pain.
Figure 20.6 Third most frequently used numbers of drugs in the Treatment of Neuropathic Pain
Figure 21.1 Average relief from Neuropathic Pain (% reduction) following treatment of patients with Diabetes.
Figure 21.2 Average relief from Neuropathic Pain (% reduction) following treatment of patients post cancer radiotherapy or cancer chemotherapy.
Figure 21.3 Average relief from Neuropathic Pain (% reduction) following treatment of patients following general surgery.
Figure 21.4 Average relief from Neuropathic Pain (% reduction) following treatment of patients with Trigeminal Neuralgia.
Figure 21.5 Average relief from Neuropathic Pain (% reduction)
following treatment of patients with viral infection.
Figure 21.6 Average relief from Neuropathic Pain (% reduction) following treatment of patients with injury or trauma.
Figure 21.7 Average relief from Neuropathic Pain (% reduction) following treatment of patients post back surgery.
Figure 21.8 Average relief from Neuropathic Pain (% reduction) following treatment of patients with primary back problems.
Figure 21.9 Average relief from Neuropathic Pain (% reduction) following treatment of patients with Complex Regional Pain Syndrome (CRPS).
Figure 21.10 Average relief from Neuropathic Pain (% reduction) following treatment of patients with Multiple Sclerosis.
Figure 21.11 Average relief from Neuropathic Pain (% reduction) following treatment of patients with Central Pain.
Figure 21.12 Average relief from Neuropathic Pain (% reduction) following treatment of patients with Arthritis.
Figure 21.13 Average relief from Neuropathic Pain (% reduction) following treatment of patients with other conditions.
Figure 21.14 Mean relief from Neuropathic Pain (% reduction) following treatment for all underlying conditions.
Figure 22.1 The percentage of physicians who use interventional treatments for the treatment of Neuropathic Pain
Figure 22.2 The use of interventional treatments by physicians forNeuropathic Pain (number of practitioner responses for each treatment)
Figure 22.3 The use of interventional treatments by physicians for Neuropathic Pain (mean % of physicians using treatments)
Figure 25.1 General limitations and issues associated with the treatment of neuropathic pain.
Tables
Table 2.1 Approved drugs used for the treatment of Neuropathic Pain (Drug names, Companies and Drug Mechanisms)
Table 2.2 Approved used for the treatment of Neuropathic Pain (Drug names and Neuropathic Pain Subtypes)
Table 3.1 Phase III compounds being developed for the treatment of Neuropathic Pain (Drug names, Companies and Drug Mechanisms)
Table 3.2. Phase III candidates being developed for the treatment of Neuropathic Pain (Drug names and Neuropathic Pain Subtypes)
Table 4.1 Phase II compounds being developed for the treatment of Neuropathic Pain (Drug names, Companies and Drug Mechanisms)
Table 4.2 Phase II compounds being developed for the treatment of Neuropathic Pain (Drug names and Neuropathic Pain Subtypes)
Table 5.1 Phase I compounds being developed for the treatment of Neuropathic Pain (Drug names, Companies and Drug Mechanisms)
Table 5.2 Phase I compounds being developed for the treatment of Neuropathic Pain (Drug names and Neuropathic Pain Subtypes)
Table 5.3 Preclinical compounds being developed for the treatment of Neuropathic Pain (Drug names, Companies and Drug Mechanisms)
Table 5.4 Preclinical compounds being developed for the treatment of Neuropathic Pain (Drug names and Neuropathic Pain Subtypes)
Table 8.1 Participant Countries
Table 10.1 Other diagnoses associated with Neuropathic Pain
Table 20.1 Most frequently used drug class combinations for the treatment of Neuropathic Pain
Table 20.2 Second most frequently used drug class combinations for the treatment of Neuropathic Pain.
Table 20.3. Third most frequently used drug class combinations for the treatment of Neuropathic Pain.
Table 21.1 Comparative average relief from Neuropathic Pain (% reduction) following treatment for all underlying conditions.
Table 22.1 The use of interventional treatments by physicians for Neuropathic Pain (number of practitioner responses for each treatment)
Table 22.2 The use of interventional treatments by physicians for Neuropathic Pain (mean % of physicians using treatments)
Table 22.3 Other interventional treatments used by physicians for the treatment of Neuropathic Pain
Table 24.1 Study participants
Table 25.1 General limitations and issues associated with the treatment of neuropathic pain.
Appendix 1. Responses of study participants to the question: What are the major issues and challenges associated with the treatment of neuropathic pain? Responses given by physicians to this question (which in some cases may be brief, informal or abbreviated) are presented "as is", except in those some cases where minor grammatical or typographical corrections have been made for reasons of clarity.
Appendix 2. Responses of study participants to the question: Any further comments relating to the treatment of Neuropathic Pain? Responses physicians to this question by physicians (which in some cases may be brief, informal or abbreviated) are presented "as is", except in those cases where minor grammatical or typographical corrections have been necessary for reasons of clarity.
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