IntroductionThe moderate to severe chronic nociceptive pain market has boomed in the years since the removal of generic extended-release oxycodone from the US, growing in value to eclipse $10 billion. However, this reprieve will be short-lived with the pipeline and recently-launched drugs unable to fill the void left by generic erosion of OxyContin (controlled-release oxycodone, Purdue).Scope*Analysis of patient segmentation, epidemiology, current treatment approaches, the patient acquisition process and clinical unmet needs*Breakdown of historic (200509) and future (201019) prescription sales across the seven major markets (US, Japan, France, Germany, Italy, Spain, UK)*Review of key pipeline trends, issues in clinical trial design and the implications of Risk Evaluation and Mitigation Strategies required by the FDA*Commercial and clinical assessment of key late-stage pipeline drugs, with key opinion leader comment and region-specific sales forecasts to 2019HighlightsAided by continued growth of OxyContin and the launch of opioids incorporating anti-abuse technologies, the market is set to peak at $11.7 billion in 2012. Thereafter, the market will contract to reach $10.5 billion in 2019, when the effect of patent expiries on key brands offsets sales growth of new drugs.Nucynta ER is the most clinically and commercially attractive pipeline drug, eclipsing the gold standard OxyContin. Backed by Johnson & Johnson, Nucynta ER is forecast to make a significant impact upon the market. Remoxy (extended-release oxycodone, King) and EG-P066 (extended-release morphine) are also both expected to feature as leading brands.Expectations of the novel anti-NGF class have been dampened following revelations of the osteoarthritis-worsening side effects of tanezumab (RN624, Pfizer). Datamonitor predicts that tanezumab, an NGF monoclonal antibody, will reach the market; however, as a last line therapy in severe cancer pain.Reasons to Purchase*Quantify the current and future size of the moderate to severe chronic nociceptive pain market*Understand the country-specific impact of key events in the moderate to severe chronic nociceptive pain market during the forecast period 2010-19*Identify potential licensing opportunities based on product portfolios and anticipated market needs
Abdominal Aortic Aneurysms Global Clinical Trials Review, H1, 2013
Pipeline and Commercial Insight: Moderate to Severe Chronic Nociceptive Pain - Anti-abuse opioids set to prosper
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Pipeline and Commercial Insight: Moderate to Severe Chronic
Nociceptive Pain - Anti-abuse opioids set to prosper
Published on August 2010
Report Summary
Introduction
The moderate to severe chronic nociceptive pain market has boomed in the years since the removal of generic extended-release
oxycodone from the US, growing in value to eclipse $10 billion. However, this reprieve will be short-lived with the pipeline and
recently-launched drugs unable to fill the void left by generic erosion of OxyContin (controlled-release oxycodone, Purdue).
Scope
*Analysis of patient segmentation, epidemiology, current treatment approaches, the patient acquisition process and clinical unmet
needs
*Breakdown of historic (200509) and future (201019) prescription sales across the seven major markets (US, Japan, France,
Germany, Italy, Spain, UK)
*Review of key pipeline trends, issues in clinical trial design and the implications of Risk Evaluation and Mitigation Strategies required
by the FDA
*Commercial and clinical assessment of key late-stage pipeline drugs, with key opinion leader comment and region-specific sales
forecasts to 2019
Highlights
Aided by continued growth of OxyContin and the launch of opioids incorporating anti-abuse technologies, the market is set to peak at
$11.7 billion in 2012. Thereafter, the market will contract to reach $10.5 billion in 2019, when the effect of patent expiries on key
brands offsets sales growth of new drugs.
Nucynta ER is the most clinically and commercially attractive pipeline drug, eclipsing the gold standard OxyContin. Backed by
Johnson & Johnson, Nucynta ER is forecast to make a significant impact upon the market. Remoxy (extended-release oxycodone,
King) and EG-P066 (extended-release morphine) are also both expected to feature as leading brands.
Expectations of the novel anti-NGF class have been dampened following revelations of the osteoarthritis-worsening side effects of
tanezumab (RN624, Pfizer). Datamonitor predicts that tanezumab, an NGF monoclonal antibody, will reach the market; however, as a
last line therapy in severe cancer pain.
Reasons to Purchase
*Quantify the current and future size of the moderate to severe chronic nociceptive pain market
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*Understand the country-specific impact of key events in the moderate to severe chronic nociceptive pain market during the forecast
period 2010-19
*Identify potential licensing opportunities based on product portfolios and anticipated market needs
Table of Content
Overview 1
Catalyst 1
Summary 1
About Datamonitor Healthcare 2
About the central nervous system pharmaceutical analysis team 2
Executive Summary 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 5
Upcoming related reports 5
Table of Contents 6
1. Patient Potential 7
Key findings 7
Definition of moderate to severe chronic nociceptive pain 8
Duration 8
An important distinction is the duration or longevity of pain 8
Severity 8
Patients' self-reporting of pain intensity is the most commonly used method 8
Etiology 9
Only pain of nociceptive etiology will be included in Datamonitor's chronic pain definition 9
Symptoms 10
Severe chronic pain associated with not just pain, but also mental disorders 10
Diagnosis and treatment rates 11
Chronic pain is always diagnosed, but treatment does not always ensue 11
Patient segmentation 11
Disease severity 11
Moderate pain is twice as common as severe pain in the chronic population 11
Disease causation 12
Back pain and arthritic conditions are the most prevalent chronic pain indications 12
Pathophysiology 14
Nociceptive mechanisms predominate in chronic pain 14
Age 14
Prevalence of chronic pain increases with age 14
Epidemiology 15
Seven major markets 15
Prevalence of chronic pain in the seven major markets is typically 15-25% 15
Moderate to severe chronic nociceptive pain represents a substantial population of approximately 67 million patients 16
Rest of world 18
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India, China and Brazil both possess enormous severe chronic pain market potential 18
Current management of chronic pain 19
Analgesics span multiple drug classes 19
Management of chronic pain by severity 20
Consequences of inadequately treated chronic pain 21
Clinical unmet need in moderate to severe chronic nociceptive pain 21
Side effects of current treatments 22
Opioid-induced bowel dysfunction presents significant unmet need 23
Respiratory depression poses a potentially fatal hazard 23
Opioid addiction and dependence are barriers to painkiller use 23
Inadequate analgesia 24
Striking the right balance between analgesia and tolerability can be difficult 24
Abuse potential of opioids 26
Incidence is on the rise but Pharma is responding 26
Other methods of misuse remain difficult to curb 26
2. Market Overview 28
Key findings 28
Market definition for this report 29
Seven major markets 29
Current and future market assessment 29
Seven major markets' value breaks $10 billion barrier but struggles thereafter 29
Sales volume growth is strong and consistent in all of the seven major markets 31
Similar growth trends expected in all of the seven major markets 32
Anti-abuse formulations set to profit at the expense of traditional oral extended-release opioids 35
Rest of the world snapshot 37
Current market assessment 37
The combined worldwide market for chronic moderate to severe pain is worth almost $12 billion 37
BRIC markets are extremely underserved and contribute just 1% of global sales 38
The Brazilian, Chinese and Indian markets are showing the strongest growth 39
OxyContin and Duragesic remain the top two highest selling chronic pain brands in the rest of the world 40
Patient acquisition process 41
Trigger point 1: physician education 42
Guidelines can be of limited use and are not strictly adhered to 42
Improved pain assessment and utilization of analgesics provides an educational opportunity 42
Trigger point 2: choice of molecule, method of administration and brand 43
No direct guidance for the choice of individual opioids and brands means marketing is crucial 43
Key developers 43
Purdue Pharma/Mundipharma/Napp Pharmaceuticals 43
Purdue Pharma is the self-styled 'pain company' 43
Diversification of research focus and geographic expansion will ensure medium-term stability 45
Johnson & Johnson 45
Duragesic propels Johnson & Johnson into second place 45
King Pharmaceuticals 46
Strategic acquisitions have forged a significant presence for King in the chronic pain market 46
Focus on anti-abuse technology creates a niche in the market for King 47
US-only products leaves opportunity for geographic expansion with commercial partners 48
Pfizer 48
Burgeoning pipeline as Pfizer Highlights pain as a priority area of research 48
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3. Brand Dynamics 49
Key findings 49
Overview of competitive landscape 50
Current leading treatment options 50
Comparative forecasts 54
OxyContin will lose its status as the market leader during the forecast period 54
Reimbursement: tiering of key brands 54
OxyContin possesses a more favorable formulary listing relative to its closest rivals 54
OxyContin (controlled-release oxycodone HCl, Purdue Pharma) 56
Drug overview 56
OxyContin is the market-leading opioid painkiller 56
Drug profile 56
Product positioning 57
Gold-standard extended-release opioid in the US market is not without problems 57
Purdue has countered with a tamper-resistant OxyContin formulation 57
Controlled-release patent successfully defended by Purdue 58
SWOT analysis 58
Brand forecast to 2019 59
Duragesic (fentanyl transdermal patch, Johnson & Johnson) 60
Drug overview 60
Market-leading transdermal patch retains significant share despite generic competition 60
Drug profile 61
Product positioning 61
Distinction from major oral brands has allowed Duragesic to occupy sizeable niche 61
Recalls have harmed Duragesic's strong brand name 62
Other patches are beginning to encroach on the transdermal market 62
Patch formulation is still susceptible to opioid abuse 62
SWOT analysis 63
Brand forecast to 2019 64
Opana ER (extended-release oxymorphone HCl, Endo Pharmaceuticals) 64
Drug overview 64
Strong uptake for US-only extended-release oral treatment 64
Drug profile 65
Product positioning 65
Subset of patients may benefit from alternative opioid 65
Undercutting the price of OxyContin ensured rapid uptake 65
Crush-resistant formulation in development 66
Patent litigation leads to early availability of generics 66
SWOT analysis 67
Brand forecast to 2019 68
Ultram ER (extended-release tramadol HCl, Johnson & Johnson) 68
Drug overview 68
Opioid with dual mode of action takes novel approach to analgesia 68
Drug profile 69
Product positioning 69
Tramadol formulations useful in less severe patients not responding to weaker non-narcotic analgesics 69
Influx of competitors expected in the US after Purdue patent deemed unenforceable 70
SWOT analysis 70
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Brand forecast to 2019 71
Kadian (extended-release morphine sulfate, Actavis) 71
Drug overview 71
Kadian was the best-selling morphine brand for chronic pain in 2009 71
Drug profile 72
Product positioning 72
Once-daily morphine dwarfed by OxyContin 72
Patent expiry in April 2010 spells the end of market exclusivity 73
SWOT analysis 73
Brand forecast to 2019 74
Avinza (extended-release morphine sulfate, King Pharmaceuticals) 74
Drug overview 74
Avinza struggles to keep pace with Kadian 74
Drug profile 75
Product positioning 75
Switching to abuse-resistant formulation will be important for King's success in chronic pain market 75
SWOT analysis 76
Brand forecast to 2019 77
Embeda (extended-release morphine sulfate/naltrexone HCl, King Pharmaceuticals) 77
Drug overview 77
Recently launched anti-abuse formulation offers comparable analgesia to Avinza 77
Drug profile 78
Product positioning 78
First-to-market abuse deterrent morphine formulation 78
Embeda will become King's leading morphine product in moderate to severe chronic pain 79
Lower price than competitors will encourage switching 79
SWOT analysis 79
Brand forecast to 2019 80
Targin (prolonged-release oxycodone/naloxone, Mundipharma) 81
Drug overview 81
First combination analgesic to tackle opioid-induced constipation 81
Drug profile 82
Product positioning 82
Novelty and meeting unmet needs has yielded commercial success for Targin in Germany 82
Switching from OxyContin is crucial but reimbursement is not guaranteed 82
SWOT analysis 84
Brand forecast to 2019 85
Transtec and Butrans (buprenorphine transdermal patch, Grünenthal/Mundipharma) 85
Drug overview 85
Mundipharma/Grünenthal's European-only transdermal patch provides competition for Duragesic 85
Drug profile 86
Product positioning 86
Viable alternative to Duragesic with slight differentiation 86
SWOT analysis 88
Brand forecast to 2019 89
4. Pipeline Overview and R&D Dynamics 90
Key findings 90
Pipeline overview 91
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Chronic pain pipeline features long-acting opioids, anti-abuse mechanisms and novel analgesic classes 91
Classification of pipeline products 92
Opioids form the basis for the majority of the 23 late-stage clinical developments 92
Clear shift of research focus away from opioids in order to address unmet needs 93
Comparative forecasts 95
Pipeline to contribute almost $2 billion to market value in 2019, with Nucynta ER taking greatest share 95
Late-stage compounds in development set to make minimal impact 96
Datamonitor's pipeline assessment summary 97
Clinical trial design 98
Patient subpopulations with chronic pain must be targeted individually 98
A variety of endpoints are used for chronic pain trials 98
Exalgo clinical trial is a useful benchmark 99
Exalgo pivotal trial overview 100
Clinical determination of abuse deterrence is unfeasible 101
Risk Evaluation and Mitigation Strategies 102
5. Pipeline Drug Analysis and Forecasts: Opioids 103
Key findings 103
Overview of opioids pipeline 104
Pipeline summary 104
Comparative forecasts 106
Definition of current comparator therapy 106
OxyContin is Datamonitor's gold standard therapy for moderate to severe chronic nociceptive pain 106
Nucynta ER (extended-release tapentadol HCl, Johnson & Johnson/Grünenthal) 107
Drug overview 107
First new opioid molecule to be approved in over 25 years 107
Comparable efficacy but reduces risk of typical opioid-induced side effects 107
Johnson & Johnson/Grünenthal are targeting all seven major markets 108
Drug profile 108
Clinical trial data 108
Efficacy data pending, but safety data strengthen claim of improved safety profile 108
SWOT analysis 111
Datamonitor drug assessment scorecard for Nucynta ER 112
Clinical and commercial attractiveness 113
Superior safety profile over existing treatments is a clear distinction in Nucynta ER's favor 113
Gradual uptake to be boosted by switching from off-label use of immediate-release formulation 114
Nucynta ER to benefit from Johnson & Johnson's and Grünenthal's substantial opioid experience 114
Satisfaction of unmet needs 114
Evidence suggests Nucynta ER will address the key unmet needs of current treatments 114
Brand forecast to 2019 115
Nucynta ER will be well-received in all of the seven major markets 115
Remoxy (extended-release oxycodone HCl, King Pharmaceuticals) 116
Drug overview 116
New tamper-resistant drug aims to reduce abuse potential of long-acting oxycodone 116
Initially met with response letter - resubmission expected soon 117
Drug profile 117
Clinical trial data 118
Remoxy demonstrates analgesic efficacy and safety typical of other opioids, but direct comparison with existing brands was not
carried out 118
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SWOT analysis 119
Datamonitor drug assessment scorecard for Remoxy 120
Clinical and commercial attractiveness 121
Demand for effective opioids with reduced abuse potential addressed by Remoxy 121
Outlook for Remoxy dealt a blow by new tamper-resistant OxyContin formulation 122
Satisfaction of unmet needs 122
Tamper-resistant capsule makes no advances in efficacy or tolerability 122
Brand forecast to 2019 123
Remoxy will capture some share from OxyContin but will not emulate its success 123
ZX002 (controlled-release hydrocodone bitartrate, Zogenix) 124
Drug overview 124
First extended-release hydrocodone product reaches Phase III 124
Drug profile 125
Clinical trial data 125
Phase II results show efficacy in moderate to severe chronic osteoarthritis pain with no severe adverse events 125
SWOT analysis 127
Datamonitor drug assessment scorecard for ZX002 128
Clinical and commercial attractiveness 129
Clinical benefit hard to quantify until Phase III results are available 129
Clear benefit over competitors should provide a clear entry point into substantial hydrocodone market 129
Satisfaction of unmet needs 130
ZX002 does not address key unmet needs identified by Datamonitor and interviewed key opinion leaders 130
Brand forecast to 2019 131
Only limited success for first extended-release hydrocodone-only product 131
TRANSDUR-Sufentanil (sufentanil transdermal patch, Durect Corporation) 132
Drug overview 132
Fentanyl analog developed as a transdermal patch formulation 132
Drug profile 133
Clinical trial data 133
Sufentanil patch demonstrates good efficacy with low incidence of application site reactions 133
SWOT analysis 135
Datamonitor drug assessment scorecard for TRANSDUR-Sufentanil 136
Clinical and commercial attractiveness 137
Durect's sufentanil patch offers distinct improvement over popular Duragesic 137
Failure to address unmet needs in face of innovative competition may limit reimbursement 138
Development currently stalled while commercial partner is sought 138
Satisfaction of unmet needs 138
New sufentanil patch offers incremental benefits but does not address unmet needs 138
Brand forecast to 2019 139
Some transdermal fentanyl patients will try the new sufentanil product, but only modest sales expected 139
EG-P066 (extended-release morphine sulfate, Egalet) 140
Drug overview 140
First erosion-based product provides abuse-resistant extended-release properties 140
Drug profile 141
Clinical trial data 141
Erosion-based morphine compares favorably with established morphine brand in Phase II clinical trial 141
SWOT analysis 143
Datamonitor drug assessment scorecard for EG-P066 144
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Clinical and commercial attractiveness 145
Strong clinical argument for EG-P066's development 145
Degree of innovation comes under the spotlight when considering commercial factors 146
Satisfaction of unmet needs 146
Abuse potential issue is certainly addressed but EG-P066 likely to fail to improve on efficacy and tolerability 146
Brand forecasts to 2019 147
Second-to-market abuse-deterrent morphine drug is forecast to eclipse Embeda sales 147
Other pipeline opioids 149
CIP-Tramadol ER (extended-release tramadol; Cipher Pharmaceuticals) 149
Green light for novel tramadol formulation to enter crowded market 149
Brand forecasts to 2019 150
Fentos (fentanyl transdermal tape, Hisamitsu/Kyowa Hakko Kirin) 150
Once-daily fentanyl patch is now available in Japan for cancer pain 150
Brand forecasts to 2019 151
Rybix (tramadol HCl orally disintegrating tablet, Victory Pharma) 151
Victory Pharma launches first orally disintegrating tramadol tablet 151
Brand forecasts to 2019 152
ADL5859 and ADL5747 (Adolor/Pfizer) 152
Potential of delta-opioid agonists for chronic pain remains unclear 152
BEMA Buprenorphine (buprenorphine buccal disc, BioDelivery Sciences International) 153
BDSI's buccal buprenorphine disc more suited for acute rather than chronic pain 153
ELI-154 and ELI-216 (controlled-release oxycodone HCl; controlled-release oxycodone HCl/naltrexone, Elite Pharmaceuticals) 153
The first once-daily oxycodone formulations are in the pipeline 153
GRT151 (axomadol, Endo Pharmaceuticals/Grünenthal) 154
Novel tramadol analog is in Phase II trials 154
MCP-201 (Mt Cook Pharma) 154
Proprietary broad-spectrum opioid receptor agonist shows promise 154
PW4142 (extended-release nalbuphine HCl, Penwest Pharmaceuticals) 154
Second entry into the market for Penwest likely to be less successful 154
MGX001 (morphine sulfate/unspecified atypical stimulant, Victory Pharma) 155
New approach targets the sedatory side effect of morphine 155
Discontinued/suspended pipeline opioids 155
6. Pipeline Drug Analysis and Forecasts: Anti-NGF Antibodies 156
Key findings 156
Overview of anti-NGF antibodies pipeline 157
Pipeline summary 158
Definition of current comparator therapy 158
Tanezumab (RN624, Pfizer) 159
Drug overview 159
Tanezumab is the most advanced anti-NGF antibody in development 159
Clinical hold enforced on tanezumab after worrisome side effects in osteoarthritis patients 159
Drug profile 160
Clinical trial data 160
Chronic pain clinical trials currently suspended by Pfizer at the FDA's request 160
Tanezumab clinical program involves 19 separate clinical trials 161
Phase II data encouraging 163
Latest Phase III data announced at EULAR 2010 165
Peripheral neuropathy and paresthesia documented in clinical studies 166
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SWOT analysis 167
Datamonitor drug assessment scorecard for tanezumab 168
Clinical and commercial attractiveness 169
Positive clinical trial results in several types of chronic pain marred by worldwide suspension of trials 169
First-to-market antibody will benefit from novelty but will be reserved for last-line therapy 170
Satisfaction of unmet needs 170
By avoiding an opioid mode of action, tanezumab addresses unmet needs of severe chronic pain therapy 170
Brand forecasts to 2019 171
Despite its anticipated restricted label, tanezumab will still launch in the seven major markets 171
REGN475 (SAR164877, Sanofi-Aventis/Regeneron) 172
Drug overview 172
Collaboration between Sanofi-Aventis and Regeneron yields promising anti-NGF antibody 172
Drug profile 173
Clinical trial data 173
Extensive Phase II program for REGN475 underway 173
Interim analysis of Phase II trial in osteoarthritis recently announced 174
SWOT analysis 175
Clinical and commercial attractiveness 176
Regeneron's antibody benefits from strategic alliance with Sanofi-Aventis 176
REGN475 may face competition on two fronts 176
Tanezumab setback may be crippling to the NGF class, or a blessing in disguise 176
Satisfaction of unmet needs 177
REGN475 will complement existing therapies well by addressing key unmet needs 177
Brand forecasts to 2019 177
Future of anti-NGF antibody class too uncertain to forecast REGN475 177
Other pipeline anti-NGF antibodies 178
JNJ-42160443 (Johnson & Johnson) 178
Clinical development underway in a variety of chronic pain-associated indications 178
7. Pipeline Drug Analysis and Forecasts: Other Non-Opioid Analgesics 180
Key findings 180
Overview of other non-opioid analgesics pipeline 181
Pipeline summary 181
Definition of current comparator therapy 181
Sativex (nabiximols, GW Pharmaceuticals) 181
Drug overview 181
Controversial medicinal cannabis product is in worldwide development for difficult-to-treat cancer pain 181
Drug profile 182
Clinical trial data 183
Sativex demonstrates statistically significant efficacy in difficult-to-treat opioid-refractory cancer patients 183
Phase IIb study conducted in the US 184
SWOT analysis 185
Datamonitor drug assessment scorecard for Sativex 186
Clinical and commercial attractiveness 187
Efficacy in hard-to-treat refractory cancer pain population 187
Novelty offset by regulatory risk and restricted labeling 188
Satisfaction of unmet needs 189
Cannabis extract goes some way to satisfying the demand for efficacy in patients with severe cancer pain 189
Brand forecasts to 2019 190
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Despite controversial mode of action, Sativex is still expected to fit into the treatment algorithm across Europe and the US 190
Other pipeline non-opioid analgesics 191
Xen2174 (Xenome) 191
XEN402 (Xenon Pharmaceuticals) 191
Bibliography 193
Books and journal papers 193
Websites 198
Datamonitor reports 204
APPENDIX 205
Forecasting assumptions 205
New product launches 205
Generic launches 206
Methodology 206
Datamonitor forecast methodology 206
Product forecasts 206
Definition of a standard unit 207
Exchange rates 207
Methodology for severe cancer pain patient-based forecast 207
Country group definitions 208
Rest of European Union 208
Middle East and North Africa (MENA) 208
Rest of World 209
Datamonitor drug assessment scorecard 209
Contributing experts 210
About Datamonitor 211
About Datamonitor Healthcare 211
About the Disease analysis team 211
Datamonitor consulting 212
Disclaimer 214
List of Tables
Table 1: Classification of pain by pathophysiology 10
Table 2: Estimated prevalence of key chronic pain indications across the seven major markets, 2010 13
Table 3: Epidemiology surveys of chronic pain, published between 1998 and 2010 16
Table 4: Estimates for the prevalence of moderate to severe chronic nociceptive pain in the seven major markets, 2010 17
Table 5: Estimates for the prevalence of severe chronic pain in the rest of the world, 2010 18
Table 6: Regional moderate to severe chronic nociceptive pain market sales value ($m) and sales volume (IMS standard units)
dynamics across the seven major markets, 2005-2019 33
Table 7: Purdue and associated companies' chronic pain portfolio, 2010 44
Table 8: Johnson & Johnson's chronic pain portfolio, 2010 46
Table 9: King Pharmaceuticals' chronic pain portfolio, 2010 47
Table 10: Pfizer's moderate to severe chronic nociceptive pain portfolio, 2010 48
Table 11: Leading treatments for moderate to severe chronic nociceptive pain, 2010 51
Table 12: Sales forecasts for key brands in moderate to severe chronic nociceptive pain in the seven major markets ($m), 2010-19 54
Table 13: Representative formulary tier status in the US for leading moderate to severe chronic nociceptive pain brands, 2010 55
Table 14: OxyContin (controlled-release oxycodone HCl, Purdue) - drug profile, 2010 56
Table 15: Sales forecasts for OxyContin in the seven major markets ($m), 2010-19 59
Table 16: Duragesic (fentanyl transdermal patch, Johnson & Johnson) - drug profile, 2010 61
Table 17: Sales forecasts for Duragesic in the seven major markets ($m), 2010-19 64
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Table 18: Opana ER (extended-release oxymorphone HCl, Endo) - drug profile, 2010 65
Table 19: Sales forecasts for Opana and Opana ER in the seven major markets ($m), 2010-19 68
Table 20: Ultram ER (extended-release tramadol HCl, Johnson & Johnson/Grünenthal) - drug profile, 2010 69
Table 21: Sales forecasts for Ultram ER in the seven major markets ($m), 2010-19 71
Table 22: Kadian (extended-release morphine sulfate, Actavis) - drug profile, 2010 72
Table 23: Sales forecasts for Kadian in the seven major markets ($m), 2010-19 74
Table 24: Avinza (extended-release morphine sulfate, King) - drug profile, 2010 75
Table 25: Sales forecasts for Avinza in the seven major markets ($m), 2010-19 77
Table 26: Embeda (extended-release morphine sulfate/naltrexone hydrochloride, King) - drug profile, 2010 78
Table 27: Sales forecasts for Embeda in the seven major markets ($m), 2010-19 80
Table 28: Targin (prolonged-release oxycodone/naloxone, Mundipharma) - drug profile, 2010 82
Table 29: Sales forecasts for Targin in the seven major markets ($m), 2010-19 85
Table 30: Transtec/Butrans (buprenorphine transdermal patch, Mundipharma/Grünenthal) - drug profile, 2010 86
Table 31: Sales forecasts for Transtec in the seven major markets ($m), 2010-19 89
Table 32: Sales forecasts for Butrans in the seven major markets ($m), 2010-19 89
Table 33: Key pipeline candidates for the treatment of moderate to severe chronic nociceptive pain, 2010 91
Table 34: Sales forecasts for pipeline products in moderate to severe chronic nociceptive pain in the seven major markets ($m),
2010-19 95
Table 35: Typical Phase III clinical trial design in chronic pain, 2010 100
Table 36: Key opioids in late-stage clinical development for the treatment of severe chronic pain, 2010 104
Table 37: Nucynta ER (extended-release tapentadol HCl) - drug profile, 2010 108
Table 38: US Phase III open-label 1-year safety trial for tapentadol ER 109
Table 39: Pivotal European Phase III trial safety results for tapentadol ER 110
Table 40: Datamonitor's drug assessment scorecard for Nucynta ER in moderate to severe chronic nociceptive pain, 2010 113
Table 41: Sales forecasts for Nucynta ER in the seven major markets ($m), 2010-19 115
Table 42: Impacting factors on the revenue of Nucynta ER, 2010-19 116
Table 43: Remoxy (extended-release oxycodone HCl) - drug profile, 2010 117
Table 44: Datamonitor's drug assessment scorecard for Remoxy in moderate to severe chronic nociceptive pain, 2010 121
Table 45: Sales forecasts for Remoxy in the seven major markets ($m), 2010-19 123
Table 46: Impacting factors on the revenue of Remoxy, 2010-19 124
Table 47: ZX002 (controlled-release hydrocodone bitartrate, Zogenix) - drug profile, 2010 125
Table 48: Key facts: Phase III trial of ZX002, 2010 126
Table 49: Datamonitor's drug assessment scorecard for ZX002 in moderate to severe chronic nociceptive pain, 2010 129
Table 50: Sales forecasts for ZX002 in the seven major markets ($m), 2010-19 131
Table 51: Impacting factors on the revenue of ZX002, 2010-19 131
Table 52: TRANSDUR-Sufentanil (sufentanil transdermal patch, Durect) - drug profile, 2010 133
Table 53: Datamonitor's drug assessment scorecard for TRANSDUR-Sufentanil in moderate to severe chronic nociceptive pain, 2010
137
Table 54: Sales forecasts for TRANSDUR-Sufentanil in the seven major markets ($m), 2010-19 139
Table 55: Impacting factors on the revenue of TRANSDUR-Sufentanil, 2010-19 140
Table 56: EG-P066 (extended-release morphine sulfate) - drug profile, 2010 141
Table 57: Datamonitor's drug assessment scorecard for EG-P066 in moderate to severe chronic nociceptive pain, 2010 145
Table 58: Sales forecasts for EG-P066 in the seven major markets ($m), 2010-19 147
Table 59: Impacting factors on the revenue of EG-P066, 2010-19 148
Table 60: Other opioids in late-stage clinical development for the treatment of severe chronic pain, 2010 149
Table 61: Sales forecasts for CIP-Tramadol ER in the seven major markets ($m), 2010-19 150
Table 62: Sales forecasts for Fentos in the seven major markets ($m), 2010-19 151
Table 63: Sales forecasts for Rybix in the seven major markets ($m), 2010-19 152
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Table 64: Discontinued/suspended pipeline GABA modulators 155
Table 65: Anti-nerve growth factor (NGF) antibodies in late-stage clinical development for the treatment of severe chronic pain, 2010
158
Table 66: Tanezumab (RN624, Pfizer) - drug profile, 2010 160
Table 67: Tanezumab - ongoing studies for the treatment of pain, 2010 161
Table 68: Datamonitor's drug assessment scorecard for tanezumab in moderate to severe chronic nociceptive pain, 2010 169
Table 69: Sales forecasts for tanezumab in the seven major markets ($m), 2010-19 171
Table 70: Impacting factors on the revenue of tanezumab, 2010-19 172
Table 71: REGN475 (SAR164877, Sanofi-Aventis/Regeneron) - drug profile, 2010 173
Table 72: REGN475 - ongoing studies for the treatment of pain, 2010 174
Table 73: JNJ-42160443 - ongoing studies for the treatment of pain, 2010 179
Table 74: Other non-opioid analgesics in late-stage clinical development for the treatment of severe chronic pain, 2010 181
Table 75: Sativex (nabiximols, GW Pharmaceuticals) - drug profile, 2010 182
Table 76: Datamonitor's drug assessment scorecard for Sativex in moderate to severe chronic nociceptive pain, 2010 187
Table 77: Sales forecasts for Sativex in the seven major markets ($m), 2010-19 190
Table 78: Impacting factors on the revenue of Sativex, 2010-19 191
Table 79: Datamonitor's launch date estimation for moderate to severe chronic nociceptive pain products in the US, five major EU
markets (5EU) and Japan, 2010-19 205
Table 80: Estimated generic launch dates for the approved moderate to severe chronic nociceptive pain drugs in the seven major
markets, 2010-19 206
Table 81: Datamonitor's drug assessment parameters for key late-stage moderate to severe chronic nociceptive pain pipeline
therapies 209
List of Figures
Figure 58: Methodology for forecasting price to remove impact of currency fluctuations on future trend 207
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