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Pipeline and Commercial Insight: Moderate to Severe Chronic Nociceptive Pain - Anti-abuse opioids set to prosper
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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 billio.....
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 *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 [Studien Infos ausblenden] |
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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 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 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 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 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 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 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 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 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 ($m), 2010-19 64 Table 18: Opana ER (extended-release oxymorphone HCl, Endo) - drug profile, 2010 65 Table 19: Sales forecasts for Opana and Opana ER in the seven major markets ($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 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 [Inhaltsverzeichnis ausblenden] |
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