Pipeline Insight: Neuropathic Pain - Emerging drugs fail to capitalize in lucrative market
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Central Nervous System pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the Neuropathic pain market - page 4
- Key metrics - page 6
- Datamonitor Pipeline Assessment Summary - page 10
- Related reports - page 10
- CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS - page 12
- Pipeline overview - page 13
- Phase II and above - page 14
- Discontinued and suspended projects - page 19
- Projects recently suspended or discontinued - page 19
- Pristiq - page 19
- Lamictal XR - page 19
- Gabapentin GR - page 19
- ACV-1 - page 19
- Namenda (memantine) - page 20
- Traxoprodil - page 20
- AZD-4282 - page 20
- Projects recently suspended or discontinued - page 19
- Key companies involved in the neuropathic pain pipeline - page 20
- Pfizer - page 20
- Neurontin - page 21
- Lyrica - page 22
- Eli Lilly - page 24
- Cymbalta - page 25
- UCB - page 26
- Vimpat - page 27
- Brivaracetam - page 27
- Pfizer - page 20
- Key R&D company strategies - page 28
- Reformulation strategies: Gabapentin - page 28
- Gabapentin GR - page 28
- XP13512 - page 29
- Patient subgroups - page 29
- Reformulation strategies: Gabapentin - page 28
- CHAPTER 3 NEUROPATHIC PAIN - MARKET OVERVIEW - page 31
- Definition of neuropathic pain - page 32
- Segmentation of neuropathic pain - page 33
- Segmentation of neuropathic pain differs depending on the geographic market - page 33
- General neuropathic pain provides a broader customer base in the EU - page 34
- US approval requires evidence in each neuropathic pain subtype - page 34
- Major neuropathic pain subtypes - page 35
- Diabetic neuropathic pain - page 35
- Post-herpetic neuralgia - page 35
- HIV neuropathic pain - page 36
- Neuropathic low-back pain - page 36
- Other subtypes - page 37
- Segmentation of neuropathic pain differs depending on the geographic market - page 33
- Epidemiology - page 37
- Diabetic neuropathic pain - page 38
- Post-herpetic neuralgia - page 39
- HIV neuropathic pain - page 40
- Post operative pain - page 40
- Current market overview - page 41
- Five treatments are currently marketed for neuropathic pain - page 41
- Off-label prescribing - page 42
- US dominated market - page 44
- Unmet need in neuropathic pain - page 45
- Clinical unmet need - page 45
- 1. Improved efficacy - page 46
- 2. Improved side effect profile - page 47
- 3. Reduced time to onset of action - page 47
- 4. Fewer drug-drug interactions - page 48
- 5. Pill burden - page 48
- Clinical unmet need - page 45
- CHAPTER 4 R&D APPROACH - page 49
- Classification of pipeline products - page 50
- Glutamate receptor modulators - page 50
- NMDA - page 50
- AMPA - page 51
- Kainate - page 51
- Ion channel modulators - page 51
- Sodium channels - page 51
- Calcium channels - page 51
- GABA modulators - page 52
- Monoamine modulators - page 52
- SNRIs - page 52
- Dopamine - page 53
- Others - page 53
- Cannabinoid agonists - page 53
- Vanilloid receptor agonists - page 54
- Substance P release modulators - page 54
- ACh receptor agonists - page 54
- NGF modulators - page 54
- TNF alpha antagonists - page 55
- Adrenoceptor modulation - page 55
- Adenosine A2 agonist - page 55
- Free radicals - page 55
- Glutamate receptor modulators - page 50
- Clinical trial design in neuropathic pain - page 56
- Choice of endpoint is the key clinical trial design factor in neuropathic pain - page 56
- Head-to-head trials of increasing importance - page 56
- Lyrica is the choice of ideal comparator drug for head-to-head clinical trials - page 56
- Length of trial should indicate titration period for physician ease of use - page 56
- The Initiative on Methods, Measurements and Pain Assessments in Clinical trials (IMMPACT) - page 57
- European Federation of Neurological Societies assessment - page 59
- Clinical trial endpoints in neuropathic pain - page 59
- 50% reduction in pain is a primary measure of efficacy - page 59
- Multiple pain and quality of life assessment questionnaires should be used in trials - page 59
- Clinical trial drop-out as an endpoint - page 64
- Choice of endpoint is the key clinical trial design factor in neuropathic pain - page 56
- Classification of pipeline products - page 50
- CHAPTER 5 GLUTAMATE RECEPTOR MODULATORS LATE-STAGE DRUG ANALYSIS & FORECASTS - page 65
- Overview of glutamate receptor modulators - page 66
- Pipeline summary - page 66
- Comparative forecasts - page 68
- Definition of current comparator therapy - page 69
- Pfizer's Lyrica is Datamonitor's comparator therapy - page 69
- Lidoderm is the topical comparator therapy - page 73
- Zenvia (dextromethorphan & quinidine sulfate) - page 73
- Drug overview - page 73
- Clinical trial data - page 74
- Phase III trial - page 74
- Patient potential - page 75
- Marketing factors - page 76
- Satisfaction of unmet needs - page 77
- Improved efficacy - page 77
- Improved side effect profile: potential to cause upset - page 77
- Reduced pill burden - page 77
- Forecasts to 2016 - page 78
- Datamonitor drug assessment summary - page 79
- NP-1 (ketamine & amitriptyline) - page 80
- Drug overview - page 80
- Clinical trial data - page 81
- Phase II trial - page 81
- Patient potential - page 82
- NP-1's topical use attracts a wide treatment range - page 82
- Potential negative aspects - page 83
- Marketing factors - page 83
- Antidepressant topical mechanism of action - page 83
- Satisfaction of unmet needs - page 84
- Improved efficacy - page 84
- Improved side effect profile - page 84
- Reduced pill burden - page 84
- Forecasts to 2016 - page 84
- Datamonitor drug assessment summary - page 86
- CNS-5161 - page 87
- Drug overview - page 87
- Clinical trial data - page 88
- Phase IIa trial - page 88
- Phase I trial - page 89
- Satisfaction of unmet needs - page 90
- Improved efficacy - page 90
- Improved side effect profile - page 90
- Reduced pill burden - page 90
- Datamonitor comments - page 91
- V3381 - page 91
- Clinical trial data - page 91
- Phase IIa study - page 91
- Phase I study - page 92
- Preclinical studies: - page 94
- Datamonitor comments - page 94
- Clinical trial data - page 91
- Other glutamate receptor modulators - page 95
- RGH-896 - page 95
- EVT-101 - page 95
- NS-1209 - page 95
- NGX-426 - page 96
- Late-stage development compounds recently discontinued - page 96
- AZD-9272 - page 96
- Overview of glutamate receptor modulators - page 66
- CHAPTER 6 ION CHANNEL MODULATORS LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 97
- Overview of ion channel modulators - page 98
- Pipeline summary - page 98
- Comparative forecasts - page 100
- Definition of current comparator therapy - page 100
- Vimpat (lacosamide) - page 101
- Drug overview - page 101
- Clinical trial data - page 101
- Phase III study - page 101
- Phase II study - page 102
- Patient potential - page 103
- Sodium channels have potential to be lucrative market - page 103
- Marketing factors - page 104
- Vimpat is being investigated for epilepsy along with other indications like many neuropathic pain treatments - page 104
- UCB looks set to become a big player in the CNS market - page 105
- Satisfaction of unmet needs - page 105
- Improved efficacy: data promising - page 105
- Improved side-effect profile - page 105
- Fewer drug-drug interactions: add to physician confidence in Vimpat - page 105
- Forecasts to 2016 - page 106
- Datamonitor drug assessment summary - page 107
- Lamictal XR - page 108
- Drug overview - page 108
- Clinical trial data - page 109
- Phase II Lamictal clinical trial - page 109
- Phase III - page 109
- Improved side effect profile: a big problem in neuropathic pain - page 110
- Forecasts to 2016 - page 111
- Ralfinamide - page 111
- Drug overview - page 111
- Clinical trial data - page 111
- Phase II study results - page 111
- Phase IIa study - page 114
- Patient potential - page 114
- Multiple neuropathic pain indications indicate mechanistic approach - page 114
- Marketing factors - page 115
- Satisfaction of unmet needs - page 116
- Improved efficacy - page 116
- Reduced time to onset of action - page 116
- Forecasts to 2016 - page 116
- Datamonitor drug assessment summary - page 118
- Other ion channel modulators - page 119
- ABT-894 - page 119
- Bupivacaine (Eladur) - page 120
- Lidocaine patch KN-48 - page 120
- Brivaracetam - page 120
- Late-stage development compounds recently discontinued - page 121
- ACV-1 - page 121
- Overview of ion channel modulators - page 98
- CHAPTER 7 GABA MODULATORS LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 123
- Overview of GABA receptor modulators - page 124
- Pipeline summary - page 124
- Comparative forecasts - page 125
- Definition of current comparator therapy - page 126
- Gabapentin GR - page 126
- Drug overview - page 126
- Clinical trial data - page 127
- Phase III study - page 127
- Phase II study - page 128
- A future for Gabapentin GR? - page 129
- Forecasts to 2016 - page 129
- XP13512 gabapentin (Enacarbil) - page 129
- Clinical trial data - page 130
- Phase IIa - page 130
- Phase I - page 131
- Marketing factors - improved duration of action - page 131
- Patient potential - page 132
- Satisfaction of unmet needs - page 132
- Improved efficacy - page 132
- Reduced pill burden - page 132
- Forecasts to 2016 - page 132
- Datamonitor drug assessment summary - page 134
- Clinical trial data - page 130
- Other GABA modulators - page 135
- Retigabine - page 135
- Overview of GABA receptor modulators - page 124
- CHAPTER 8 MONOAMINE MODULATORS LATE-STAGE ANALYSIS AND FORECASTS - page 137
- Overview of monoamine receptor modulators - page 138
- Pipeline summary - page 138
- Definition of current comparator therapy - page 138
- Pristiq (desvenlafaxine) - page 138
- Drug overview - page 138
- Clinical trial data - page 139
- Ongoing trials: Phase III - page 139
- Phase II Venlafaxine studies - page 139
- Satisfaction of unmet needs - page 140
- Forecasts to 2016 - page 140
- Other monoamine modulators - page 141
- Bicifadine - page 141
- Reboxetine (+)-(S,S) - page 141
- F13640 - page 141
- Late-stage development compounds recently discontinued - page 141
- Radafaxine (353162) - page 141
- Overview of monoamine receptor modulators - page 138
- CHAPTER 9 OTHER LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 142
- Overview of other therapies - page 143
- Pipeline summary - page 143
- Comparative forecasts - page 145
- Definition of current comparator therapy - page 146
- Fentora (fentanyl buccal transmucosal) - page 146
- Drug overview - page 146
- Clinical trial data - page 146
- Phase III study - page 147
- Patient potential - page 149
- Marketing factors - page 149
- Satisfaction of unmet needs - page 150
- Forecasts to 2016 - page 150
- Datamonitor drug assessment summary - page 151
- Sativex (GW-1000) - page 152
- Drug overview - page 152
- Clinical trial data - page 153
- Phase III DNP study - page 153
- Phase III Allodynia study - page 154
- Phase II study - page 155
- Ongoing trials - page 155
- Marketing potential - page 156
- Potential for abuse is real but multiple indication use may offset this - page 156
- Patient potential - page 156
- Satisfaction of unmet needs - page 157
- Forecasts to 2016 - page 157
- Datamonitor drug assessment summary - page 159
- Transacin (NGX-4010) - page 160
- Drug overview - page 160
- Clinical trial data - page 161
- Ongoing trials - page 161
- Phase III study - page 161
- Phase III HIV-associated neuralgia - page 162
- Phase II study - page 163
- Patient potential - page 164
- Marketing factors - page 164
- Satisfaction of unmet needs - page 164
- Reduced pill burden - page 165
- Forecasts to 2016 - page 165
- Datamonitor drug assessment summary - page 167
- Other drugs - page 168
- AS-3201 - page 168
- Botulinum toxin type A-hemagglutinin complex (Dysport) - page 169
- Zucapsaicin - page 169
- AGN 203818 - page 169
- Ibudilast (AV411) - page 169
- BVT.115959 - page 170
- 681323 - page 170
- KDS-2000 - page 170
- IP 751/CT-3 (ajulemic acid) - page 171
- Liposomal galantamine - page 171
- TAK-583 - page 171
- Overview of other therapies - page 143
- CHAPTER 10 INNOVATIVE EARLY-STAGE PROJECTS - page 172
- Key Phase I and preclinical compounds in neuropathic pain - page 173
- Selective sodium channel blockers - page 176
- Vanilloid TRPV1 antagonists - page 177
- Preclinical trial data - page 177
- NGX-1998 - page 178
- GRC-6211 - page 178
- SAR-115740 - page 178
- N-type calcium channel blockers - page 178
- Spinal cord and peripheral nerve stimulation - page 179
- Key Phase I and preclinical compounds in neuropathic pain - page 173
- BIBLIOGRAPHY - page 180
- Journals - page 180
- Websites - page 186
- Datamonitor reports - page 193
- APPENDIX A - page 194
- Methodology - page 194
- Datamonitor forecast methodology - page 194
- ICD-10 codes - page 194
- Product forecasts - page 195
- Definition of a standard unit - page 196
- Contributing experts - page 198
- Biographies - page 198
- Methodology - page 194
- APPENDIX B - page 200
- About Datamonitor - page 200
- About Datamonitor Healthcare - page 200
- Datamonitor Healthcare's therapy area capabilities - page 201
- About the Disease analysis team - page 202
- Disclaimer - page 203
- About Datamonitor - page 200
- List of Tables
- Table 1: Size of the neuropathic pain market across the 7MM ($m), 2006-2016 - page 6
- Table 2: Sales forecasts ($m) of key pipeline products in neuropathic pain, 2007-2016 - page 8
- Table 3: Number of key neuropathic pain drugs by class and phase of development, 2007 - page 14
- Table 4: Phase II & III R&D pipeline for neuropathic pain, 2007 - page 14
- Table 5: Abbreviations for neuropathic pain subtypes - page 33
- Table 6: The diabetic neuropathic pain patient populations across the 7MMs, 2007 - page 38
- Table 7: The post herpetic neuralgia patient population across the 7MMs, 2007 - page 39
- Table 8: The HIV neuropathic pain patient population across the 7MMs, 2007 - page 40
- Figure 16: Key unmet needs in neuropathic pain, 2007 - page 46
- Table 9: Recommended core outcomes measures for clinical trials of chronic pain treatment efficacy - page 58
- Table 10: Key glutamate receptor modulators in the late-stage R&D pipeline for neuropathic pain, 2007 - page 66
- Table 11: Lyrica; key facts - page 71
- Table 12: Estimated key events, approvals and launch dates impacting Zenvia's revenue forecast, 2007-2016 - page 79
- Table 13: Estimated key events, approvals and launch dates impacting NP-1's revenue forecast, 2007-2016 - page 86
- Table 14: Key ion channel modulators in the late-stage R&D pipeline for neuropathic pain, 2007 - page 98
- Table 15: Estimated key events, approvals and launch dates impacting Vimpat's revenue forecast, 2007-2016 - page 107
- Table 16: Estimated key events, approvals and launch dates impacting ralfinamide's revenue forecast, 2007-2016 - page 118
- Table 17: Key GABA modulators in the late-stage R&D pipeline for neuropathic pain, 2007 - page 124
- Table 18: Estimated key events, approvals and launch dates impacting XP13512's revenue forecast, 2007-2016 - page 134
- Table 19: Monoamine modulator in late-stage R&D pipeline for neuropathic pain, 2007 - page 138
- Table 20: Other drugs in late-stage R&D pipeline for neuropathic pain, 2007 - page 143
- Table 21: Estimated key events, approvals and launch dates impacting Fentora's revenue forecast, 2007-2016 - page 151
- Table 22: Estimated key events, approvals and launch dates impacting Sativex's revenue forecast, 2007-2016 - page 159
- Table 23: Estimated key events, approvals and launch dates impacting Transacin's revenue forecast, 2007-2016 - page 167
- Table 24: Key drugs in Phase I development for neuropathic pain, 2007I - page 173
- Table 25: Key drugs in preclinical development for neuropathic pain, 2007 - page 174
- Table 26: Neuropathic pain market definition by ICD-10 codes - page 194
- Table 27: Datamonitor drug assessment parameters - page 197
- List of Figures
- Figure 1: Forecast of the neuropathic pain market value across the 7MM, 2007-2016 - page 7
- Figure 2: Key pipeline drug sales forecasts, 2007- 2016 - page 9
- Figure 3: Datamonitor drug assessment summary of pipeline therapies in development for neuropathic pain, 2007 - page 10
- Figure 4: Drugs in development for neuropathic pain by class and development stage, 2007 - page 13
- Figure 5: Pfizer sales by therapeutic area, 2006 - page 21
- Figure 6: Sales of Neurontin, gabapentin and Lyrica for neuropathic pain ($m), 2003-06 - page 22
- Figure 7: Historical sales of Lyrica, Neurontin, Cymbalta and generic gabapentin, 2003-06 - page 23
- Figure 8: Pfizer's Lyrica and CNS sales 2004-06 ($ billion) - page 24
- Figure 9: Eli Lilly sales by therapeutic area, 2006 - page 25
- Figure 10: Cymbalta all indication sales in the 7MMs, 2003-06 ($m) - page 26
- Figure 11: UCB sales by therapeutic area, 2006 - page 27
- Figure 12: Population of neuropathic pain subtypes in the 7MMs, 2007 - page 30
- Figure 13: Sales of marketed drugs for neuropathic pain, 2006 ($m) - page 41
- Figure 14: Total neuropathic pain sales across the seven major pharmaceutical markets by region, 2003-06 - page 44
- Figure 15: Total neuropathic pain sales in the 5EU, 2006 ($m) - page 45
- Figure 17: Datamonitor drug assessment summary of key glutamate receptor modulators in development for neuropathic pain, 2007 - page 67
- Figure 18: Sales forecasts for glutamate receptor modulators in neuropathic pain across the 7MMs, 2007-2016 - page 68
- Figure 19: Sales forecast for Zenvia in neuropathic pain across the 7MMs to 2016 - page 78
- Figure 20: Datamonitor's competitive positioning analysis of Zenvia, 2007 - page 80
- Figure 21: Sales forecast for NP-1 in neuropathic pain to 2016 across the 7MMs - page 85
- Figure 22: Datamonitor's competitive positioning analysis of NP-1, 2007 - page 87
- Figure 23: Datamonitor drug assessment summary of pipeline ion channel modulators in development for neuropathic pain, 2007 - page 99
- Figure 24: Sales forecasts for ion channel modulators in neuropathic pain across the 7MMs, 2007-2016 - page 100
- Figure 25: Sales forecast for Vimpat in neuropathic pain to 2016 across the 7MMs - page 106
- Figure 26: Datamonitor's competitive positioning analysis of Vimpat in neuropathic pain, 2007 - page 108
- Figure 27: Sales forecast for ralfinamide in neuropathic pain to 2016, in the 7MMs - page 117
- Figure 28: Datamonitor's competitive positioning analysis of ralfinamide in neuropathic pain, 2007 - page 119
- Figure 29: Datamonitor drug assessment summary of pipeline GABA receptor modulators in development for neuropathic pain, 2007 - page 125
- Figure 30: Sales forecasts for GABA modulators in neuropathic pain to 2016 in the 7MMs - page 126
- Figure 31: Sales forecast for XP13512 to 2016 in neuropathic pain across the 7MMs - page 133
- Figure 32: Datamonitor's competitive positioning analysis of XP13512, 2007 - page 135
- Figure 33: Datamonitor drug assessment summary other therapies in development for neuropathic pain, 2007 - page 144
- Figure 34: Sales forecasts for 'Other' drugs in neuropathic pain to 2016 across the 7MMs - page 145
- Figure 35: Sales forecast for Fentora in neuropathic pain to 2016 in the 7MMs - page 150
- Figure 36: Datamonitor's competitive positioning analysis of Fentora in neuropathic pain, 2007 - page 152
- Figure 37: Sales forecast for Sativex in neuropathic pain to 2016 in the 7MMs - page 158
- Figure 38: Datamonitor's competitive positioning analysis of Sativex for neuropathic pain, 2007 - page 160
- Figure 39: Sales forecast for Transacin in neuropathic pain to 2016 in the 7MMs - page 166
- Figure 40: Datamonitor's competitive positioning analysis of Transacin in neuropathic pain, 2007 - page 168
- Figure 41: Datamonitor drug assessment summary of neuropathic pain treatments, 2007 - page 198
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