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Pipeline Insight: Nociceptive Pain - Safety Profile Uppermost in Crowded MarketPublished by: Datamonitor Published: Oct. 21, 2004 - 264 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the nociceptive pain market 4 There are few novel drugs in the nociceptive pain pipeline, and market specialization is currently the most popular drug development strategy. 4 Morphine is still the most effective treatment available for nociceptive pain, and nothing in the pipeline looks set to replace it for the foreseeable future. 6 In-depth trial data on the safety of new NSAID drugs is key to their success in a market where it may be the only factor with which to differentiate between drugs. After Vioxx’s withdrawal, longer and more detailed trials will be needed. 7 Many of the pipeline drugs for nociceptive pain are reformulations of previously marketed drugs, or drug types. It is doubtful this strategy will bring much success when experts prefer standard oral tablets, and it is a trend that cannot continue for much longer 9 Summary 12 Key metrics 13 Datamonitor pipeline assessment summary 14 CHAPTER 2 PATIENT POTENTIAL 31 Definition of pain 32 Nociceptive pain 32 Neuropathic pain 33 Segmentation and epidemiology of nociceptive pain 34 Acute pain 35 Postoperative pain 35 Cancer pain 36 Breakthrough pain 38 Chronic non-malignant pain 39 Arthritis 39 HIV-related pain 41 Back pain 43 Diagnosis of pain type 43 Diagnosis of pain severity 44 Treatment of nociceptive pain 47 Acute pain and cancer pain 47 Chronic non-malignant pain 48 Unmet needs in nociceptive pain 49 Improved efficacy 49 Adverse side effects 49 Opioids 50 NSAIDS 51 Around-the-clock pain management 52 Physician awareness 53 Patient awareness 54 CHAPTER 3 R&D APPROACH 56 Classification of pipeline products 57 Opioids 58 Opioid combination therapies 61 NSAIDs 62 Other analgesics 65 Adjuvant analgesics 65 Clinical trial design in nociceptive pain 65 Design 65 Patient population 66 Duration 66 Gold standard 67 Clinical trial endpoints in nociceptive pain 67 Pain questionnaires 68 Other endpoints 73 Dose-response relationships 73 Pain diaries 73 Demand for opiates 74 CHAPTER 4 NOCICEPTIVE PAIN PIPELINE ANALYSIS 75 Pipeline overview 76 Key companies involved in the nociceptive pain pipeline 91 GSK 91 Merck & Co. 92 Endo 94 Strategies for success 96 Pain prevention 96 Drug delivery formulations/reformulations 99 Oral delivery formulations 100 Intravenous delivery formulations 101 Transmucosal delivery formulations 102 Transdermal delivery formulations 102 Key drug delivery strategies in the pain market 103 Depression and pain relief 105 CHAPTER 5 OPIOID DRUGS LATE-STAGE DRUG ANALYSIS & FORECASTS 110 Overview for opioid drugs 111 Pipeline summary 111 Opioid summary 112 Definition of current comparator therapy 114 DepoDur 115 Drug overview 115 Clinical trial data 116 Phase III 116 Phase II 116 Phase I 117 Patient potential 118 Marketing 118 Satisfaction of unmet needs 118 Forecasts to 2014 120 Datamonitor drug assessment summary 121 Contramid tramadol 122 Drug overview 122 Clinical trial data 122 Phase III 122 Phase II 123 Patient potential 123 Marketing 124 Satisfaction of unmet needs 125 Forecasts to 2014 125 Datamonitor drug assessment summary 127 E-TRANS fentanyl (Ionsys) 128 Drug overview 128 Clinical trial data 129 Phase III 129 Phase II 129 Phase I 129 Patient potential 130 Marketing 130 Satisfaction of unmet needs 130 Forecasts to 2014 132 Datamonitor drug assessment summary 133 CEE-04-410 134 Drug Overview 134 Clinical trial data 134 Phase III 134 Phase II 135 Patient potential 136 Marketing 136 Satisfaction of unmet needs 136 Forecasting to 2014 137 Datamonitor drug assessment summary 139 Other opioids 140 Cancer pain 140 M6G 140 Morphine (nasal formulation) 141 Clinical trial data 141 OxyTrex (PTI-801) 143 Clinical trial data 143 Rapinyl 144 TA-2620 144 Chronic non-malignant pain 145 Chronogesic 145 Clinical trial data 146 CJC-1008 147 Clinical trial data 148 Dilaudid (hydromorphone) CR 149 JTC-801 149 Oxymorphone IR & ER 150 Clinical trial data 151 Q-8003 152 Ralivia ER 152 Tramadol hydrochloride controlled-release (THCR) 153 VANH-36 153 Acute pain 153 Aero-LEF 153 DPI-3290 (ORG-41793) 154 REN-213 / REN-214 155 Late-stage development compounds recently discontinued 156 MorphiDex 156 Oral transmucosal fentanyl 157 Morphine Medipad 158 Comparison of key compounds in opioid drugs 159 Improved efficacy 159 Better side-effect profile 159 Around-the-clock pain management 160 Physician/patient awareness 161 Marketing strength 161 Comparative forecasts 162 CHAPTER 6 NSAIDS LATE-STAGE DRUG ANALYSIS AND FORECASTS 163 Overview for NSAIDs 164 Pipeline summary 164 Definition of current comparator therapy 164 COX-2 inhibitors 165 Prexige (lumiracoxib) 166 Drug overview 166 Clinical trial data 167 Patient potential 170 Marketing 170 Satisfaction of unmet needs 170 Forecasts to 2014 171 Datamonitor drug assessment summary 173 Licofelone 174 Drug overview 174 Clinical trial data 175 Patient potential 177 Marketing 177 Satisfaction of unmet needs 177 Forecasts to 2014 179 Datamonitor drug assessment summary 180 Other COX-2 inhibitors 181 Cimicoxib 181 Clinical trial data 181 GW-406381 182 Standard NSAIDs 182 NO-naproxen (HCT 3012) 182 Phase II 183 Phase I 185 Marketing 186 Lipoxin-A 186 Acetaminophen 186 Intravenous diclofenac 187 Late-stage development compounds recently discontinued 188 NO-COX-2 inhibitor 188 Comparison of key compounds in NSAIDs 189 Improved efficacy 189 Better side-effect profile 190 Around-the-clock pain management 190 Physician/patient awareness 190 Marketing strength 190 Comparative forecasts 191 CHAPTER 7 OTHER ANALGESICS LATE-STAGE DRUG ANALYSIS AND FORECASTS 192 Overview for other analgesics 193 Pipeline summary 193 Definition of current comparator therapy 194 Cannabinoids 194 THC monotherapy 194 Drug overview 194 Clinical trial data 195 Patient potential 196 Marketing 197 Satisfaction of unmet needs 197 Forecasting to 2014 199 Datamonitor drug assessment summary 200 SAB-378 201 Other analgesics 201 Prialt (ziconotide) 201 Drug overview 201 Clinical trial data 202 Patient potential 203 Marketing 204 Satisfaction of unmet needs 204 Forecasts to 2014 205 Datamonitor drug assessment summary 206 Bicifadine SR 207 Drug overview 207 Clinical trial data 209 Patient potential 210 Marketing 210 Satisfaction of unmet needs 210 Forecasting to 2014 211 Datamonitor Drug Assessment 212 ALGRX 4975 213 Tectin 213 Clinical trial data 214 Intranasal ketamine 214 Clinical trial data 215 LidoPAIN-SP / BP 216 Clinical trial data 217 EpiCept MS Spray 218 LY-293558 218 Clinical trial data 218 APF-112 219 Clinical trial data 220 Anti-inflammatory drugs 221 M-40403 221 NCX-701 222 Clinical trial data 223 AM-336 224 Late-stage development compounds recently discontinued 225 Fadolmidine 225 Tebanicline 225 YM-598 226 Comparison of key compounds in other analgesics 226 Improved efficacy 227 Better side-effect profile 227 Around-the-clock pain management 227 Physician/patient awareness 228 Marketing strength 228 Comparative forecasts 229 CHAPTER 8 INNOVATIVE EARLY-STAGE PROJECTS 230 Key Phase I and preclinical compounds in nociceptive pain 231 Acetylcholine receptor modulators 231 Bradykinin antagonists 234 Vanilloid receptor antagonists 235 Key research impacts on nociceptive pain 238 Gene therapy for pain 238 APPENDIX A 241 Contributing experts 241 Bibliography 241 General 241 Epidemiology 249 Clinical trial data 251 Websites 252 Report methodology 254 Pipeline-drug forecast methodology 254 Predicting initial market share 254 Clinical competitiveness attributes 255 Order of entry 255 Pre-launch awareness 255 Market composition 255 Marketing plan 256 Marketing strength 256 Forecasting future growth 256 Influencing factors 256 Datamonitor drug assessment summary 257 APPENDIX B 260 About Datamonitor 260 About Datamonitor Healthcare 260 Datamonitor Healthcare’s research and analysis methodologies 261 Datamonitor Healthcare’s therapy area capabilities 261 About the CNS analysis team 262 Key therapy team members 263 Lynda Lynch, Director CNS 263 David Abramson, Therapeutic Lead Consultant 263 Disclaimer 264 AbstractIntroductionThe nociceptive pain pipeline contains few novel drugs, instead being filled with reformulations and drug combinations. To make a drug stand out in this replete market, particularly at a time when there is great public concern about drug withdrawals, it must have an unquestionable safety profile, proven over long-term trials. Scope Epidemiology of nociceptive pain across the seven major markets, as well as analysis of the main unmet needs in the current treatment of the disease Overview of drugs in Phase III, II, I and preclinical development, plus analysis of key companies involved in the R&D pipeline: GSK, Merck and Endo Comprehensive analysis of key late-stage products including DepoDur, Ionsys, Prexige, Prialt & THC monotherapy, with drug revenues forecast to 2014 Insight into innovative early stage products, including vanilloid and Bradykinin receptors, plus analysis of key research into gene therapy for pain Highlights Although pain is not a new phenomenon, better education for patients, physicians, nurses and pharmacists is still an unmet need. The current range of therapies should be sufficient for pain relief if used knowledgably. New COX-2 inhibiting drugs will have to provide impeccable safety data from long-term trials before gaining approval in the current climate where the whole class of drugs is suspect. If safety can be proved, the market is relatively small, and new entrants may do well. While experts believe morphine is still the most effective painkiller available, it can be improved upon in terms of convenience and side effects. Many opioids in development are reformulations of old drugssustained release, or patch deliveryor receptor-specific drugs aiming to reduce side effects. Reasons to Purchase Enhance your sales forecasting ability and future product positioning through identification of market drivers and key competitors Optimize your knowledge of company strategies in the nociceptive pain market Identify areas of the market that are not being targeted by competitors Get Full Details About This Report >> |
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