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CNS / Neurology

Pipeline Insight: Nociceptive Pain

Safety Profile Uppermost in Crowded Market

Publication Date   October 2004
Publisher   Datamonitor
Product Type   Report
Pages   264
ISBN Number   not applicable
Product Code   DAT240
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Summary


Introduction

The 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 of this report

  • 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

Research and analysis 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.

Key reasons to read this report

  • 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

Content


  • Chapter 1 Executive Summary
    • Scope of the analysis
    • Datamonitor insight into the nociceptive pain market
    • There are few novel drugs in the nociceptive pain pipeline, and market specialization is currently the most popular drug development strategy.
    • 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.
    • 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.
    • 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
    • Summary
    • Key metrics
    • Datamonitor pipeline assessment summary
  • Chapter 2 Patient Potential
    • Definition of pain
    • Nociceptive pain
    • Neuropathic pain
    • Segmentation and epidemiology of nociceptive pain
    • Acute pain
    • Postoperative pain
    • Cancer pain
    • Breakthrough pain
    • Chronic non-malignant pain
    • Arthritis
    • HIV-related pain
    • Back pain
    • Diagnosis of pain type
    • Diagnosis of pain severity
    • Treatment of nociceptive pain
    • Acute pain and cancer pain
    • Chronic non-malignant pain
    • Unmet needs in nociceptive pain
    • Improved efficacy
    • Adverse side effects
    • Opioids
    • NSAIDS
    • Around-the-clock pain management
    • Physician awareness
    • Patient awareness
  • Chapter 3 R&d Approach
    • Classification of pipeline products
    • Opioids
    • Opioid combination therapies
    • NSAIDs
    • Other analgesics
    • Adjuvant analgesics
    • Clinical trial design in nociceptive pain
    • Design
    • Patient population
    • Duration
    • Gold standard
    • Clinical trial endpoints in nociceptive pain
    • Pain questionnaires
    • Other endpoints
    • Dose-response relationships
    • Pain diaries
    • Demand for opiates
  • Chapter 4 Nociceptive Pain Pipeline Analysis
    • Pipeline overview
    • Key companies involved in the nociceptive pain pipeline
    • GSK
    • Merck & Co.
    • Endo
    • Strategies for success
    • Pain prevention
    • Drug delivery formulations/reformulations
    • Oral delivery formulations
    • Intravenous delivery formulations
    • Transmucosal delivery formulations
    • Transdermal delivery formulations
    • Key drug delivery strategies in the pain market
    • Depression and pain relief
  • Chapter 5 Opioid Drugs Late-Stage Drug Analysis & Forecasts
    • Overview for opioid drugs
    • Pipeline summary
    • Opioid summary
    • Definition of current comparator therapy
    • DepoDur
    • Drug overview
    • Clinical trial data
    • Phase III
    • Phase II
    • Phase I
    • Patient potential
    • Marketing
    • Satisfaction of unmet needs
    • Forecasts to 2014
    • Datamonitor drug assessment summary
    • Contramid tramadol
    • Drug overview
    • Clinical trial data
    • Phase III
    • Phase II
    • Patient potential
    • Marketing
    • Satisfaction of unmet needs
    • Forecasts to 2014
    • Datamonitor drug assessment summary
    • E-TRANS fentanyl (Ionsys)
    • Drug overview
    • Clinical trial data
    • Phase III
    • Phase II
    • Phase I
    • Patient potential
    • Marketing
    • Satisfaction of unmet needs
    • Forecasts to 2014
    • Datamonitor drug assessment summary
    • CEE-04-410
    • Drug Overview
    • Clinical trial data
    • Phase III
    • Phase II
    • Patient potential
    • Marketing
    • Satisfaction of unmet needs
    • Forecasting to 2014
    • Datamonitor drug assessment summary
    • Other opioids
    • Cancer pain
    • M6G
    • Morphine (nasal formulation)
    • Clinical trial data
    • OxyTrex (PTI-801)
    • Clinical trial data
    • Rapinyl
    • TA-2620
    • Chronic non-malignant pain
    • Chronogesic
    • Clinical trial data
    • CJC-1008
    • Clinical trial data
    • Dilaudid (hydromorphone) CR
    • JTC-801
    • Oxymorphone IR & ER
    • Clinical trial data
    • Q-8003
    • Ralivia ER
    • Tramadol hydrochloride controlled-release (THCR)
    • VANH-36
    • Acute pain
    • Aero-LEF
    • DPI-3290 (ORG-41793)
    • REN-213 / REN-214
    • Late-stage development compounds recently discontinued
    • MorphiDex
    • Oral transmucosal fentanyl
    • Morphine Medipad
    • Comparison of key compounds in opioid drugs
    • Improved efficacy
    • Better side-effect profile
    • Around-the-clock pain management
    • Physician/patient awareness
    • Marketing strength
    • Comparative forecasts
  • Chapter 6 Nsaids Late-Stage Drug Analysis And Forecasts
    • Overview for NSAIDs
    • Pipeline summary
    • Definition of current comparator therapy
    • COX-2 inhibitors
    • Prexige (lumiracoxib)
    • Drug overview
    • Clinical trial data
    • Patient potential
    • Marketing
    • Satisfaction of unmet needs
    • Forecasts to 2014
    • Datamonitor drug assessment summary
    • Licofelone
    • Drug overview
    • Clinical trial data
    • Patient potential
    • Marketing
    • Satisfaction of unmet needs
    • Forecasts to 2014
    • Datamonitor drug assessment summary
    • Other COX-2 inhibitors
    • Cimicoxib
    • Clinical trial data
    • GW-406381
    • Standard NSAIDs
    • NO-naproxen (HCT 3012)
    • Phase II
    • Phase I
    • Marketing
    • Lipoxin-A
    • Acetaminophen
    • Intravenous diclofenac
    • Late-stage development compounds recently discontinued
    • NO-COX-2 inhibitor
    • Comparison of key compounds in NSAIDs
    • Improved efficacy
    • Better side-effect profile
    • Around-the-clock pain management
    • Physician/patient awareness
    • Marketing strength
    • Comparative forecasts
  • Chapter 7 Other Analgesics Late-Stage Drug Analysis And Forecasts
    • Overview for other analgesics
    • Pipeline summary
    • Definition of current comparator therapy
    • Cannabinoids
    • THC monotherapy
    • Drug overview
    • Clinical trial data
    • Patient potential
    • Marketing
    • Satisfaction of unmet needs
    • Forecasting to 2014
    • Datamonitor drug assessment summary
    • SAB-378
    • Other analgesics
    • Prialt (ziconotide)
    • Drug overview
    • Clinical trial data
    • Patient potential
    • Marketing
    • Satisfaction of unmet needs
    • Forecasts to 2014
    • Datamonitor drug assessment summary
    • Bicifadine SR
    • Drug overview
    • Clinical trial data
    • Patient potential
    • Marketing
    • Satisfaction of unmet needs
    • Forecasting to 2014
    • Datamonitor Drug Assessment
    • ALGRX 4975
    • Tectin
    • Clinical trial data
    • Intranasal ketamine
    • Clinical trial data
    • LidoPAIN-SP / BP
    • Clinical trial data
    • EpiCept MS Spray
    • LY-293558
    • Clinical trial data
    • APF-112
    • Clinical trial data
    • Anti-inflammatory drugs
    • M-40403
    • NCX-701
    • Clinical trial data
    • AM-336
    • Late-stage development compounds recently discontinued
    • Fadolmidine
    • Tebanicline
    • YM-598
    • Comparison of key compounds in other analgesics
    • Improved efficacy
    • Better side-effect profile
    • Around-the-clock pain management
    • Physician/patient awareness
    • Marketing strength
    • Comparative forecasts
  • Chapter 8 Innovative Early-Stage Projects
    • Key Phase I and preclinical compounds in nociceptive pain
    • Acetylcholine receptor modulators
    • Bradykinin antagonists
    • Vanilloid receptor antagonists
    • Key research impacts on nociceptive pain
    • Gene therapy for pain
  • Appendix A
    • Contributing experts
    • Bibliography
    • General
    • Epidemiology
    • Clinical trial data
    • Websites
    • Report methodology
    • Pipeline-drug forecast methodology
    • Predicting initial market share
    • Clinical competitiveness attributes
    • Order of entry
    • Pre-launch awareness
    • Market composition
    • Marketing plan
    • Marketing strength
    • Forecasting future growth
    • Influencing factors
    • Datamonitor drug assessment summary
  • Appendix B
  • List of Tables
    • Table 1: Key parameters of nociceptive pain
    • Table 2: Forecast key pipeline products in nociceptive pain, 2004-11
    • Table 3: Summary of commercial and research/clinical attractiveness of late-phase drugs for nociceptive pain
    • Table 4: Prevalence of postoperative pain across the seven major markets, 2004
    • Table 5: Prevalence of cancer pain across the seven major markets, 2004
    • Table 6: Prevalence of OA pain across the seven major markets, 2004
    • Table 7: Prevalence of RA pain across the seven major markets, 2004
    • Table 8: Prevalence of HIV pain across the seven major markets, 2004
    • Table 9: Prevalence of back pain across the seven major markets, 2004
    • Table 10: Nociceptive pain, pre-registration drugs, 2004
    • Table 11: Nociceptive pain Phase III pipeline, 2004
    • Table 12: Nociceptive pain, Phase II pipeline, 2004
    • Table 13: Nociceptive pain, Phase II pipeline, 2004, continued
    • Table 14: Nociceptive pain Phase I pipeline, 2004
    • Table 15: Nociceptive pain Phase I pipeline, 2004, continued
    • Table 16: Nociceptive pain preclinical pipeline, 2004
    • Table 17: Nociceptive pain preclinical pipeline, 2004, continued
    • Table 18: Nociceptive pain preclinical pipeline, 2004, continued
    • Table 19: Nociceptive pain preclinical pipeline, 2004, continued
    • Table 20: Nociceptive pain preclinical pipeline, 2004, continued
    • Table 21: Nociceptive pain preclinical pipeline, 2004, continued
    • Table 22: GlaxoSmithKline's nociceptive pain pipeline, 2004
    • Table 23: Merck & Co.'s nociceptive pain pipeline, 2004
    • Table 24: Endo's nociceptive pain pipeline, 2004
    • Table 25: Recent pain/depression studies
    • Table 26: Key late-stage pipeline opioid drugs, 2004
    • Table 27: Global sales forecasts for DepoDur, 2004-14
    • Table 28: Impacting factors on the revenues of DepoDur, 2004-14
    • Table 29: Research/clinical and commercial attractiveness of DepoDur
    • Table 30: Global sales forecasts for Contramid tramadol, 2004-14
    • Table 31: Impacting factors on the revenues of Contramid tramadol, 2004-14
    • Table 32: Research/clinical and commercial attractiveness of Contramid tramadol
    • Table 33: Global sales forecasts for E-TRANS fentanyl, 2004-14
    • Table 34: Impacting factors on the revenues of E-TRANS fentanyl, 2004-14
    • Table 35: Research/clinical and commercial attractiveness of E-TRANS Fentanyl
    • Table 36: Global sales forecasts for CEE-04-410, 2004-14
    • Table 37: Impacting factors on the revenues of CEE-04-410, 2004-14
    • Table 38: Research/clinical and commercial attractiveness of CEE-04-410
    • Table 39: Global sales forecasts for opioid drugs ($m), 2004-14
    • Table 40: Key late-stage pipeline NSAIDs, 2004
    • Table 41: Global sales forecasts for Prexige, 2004-14
    • Table 42: Impacting factors on the revenues of Prexige, 2004-14
    • Table 43: Research/clinical and commercial attractiveness of Prexige
    • Table 44: Global sales forecasts for licofelone, 2004-14
    • Table 45: Impacting factors on the revenues of licofelone, 2004-14
    • Table 46: Research/clinical and commercial attractiveness of licofelone
    • Table 47: Global sales forecasts for NSAID drugs ($m), 2004-14
    • Table 48: Key late-stage pipeline other analgesics, 2004
    • Table 49: Global sales forecasts for THC monotherapy, 2004-14
    • Table 50: Impacting factors on the revenues of THC monotherapy, 2004-14
    • Table 51: Research/clinical and commercial attractiveness of THC monotherapy
    • Table 52: Global sales forecasts for Prialt, 2004-14
    • Table 53: Impacting factors on the revenues of Prialt, 2004-14
    • Table 54: Research/clinical and commercial attractiveness of Prialt
    • Table 55: Global sales forecasts for bicifadine SR, 2004-14
    • Table 56: Impacting factors on the revenues of bicifadine, 2004-14
    • Table 57: Research/clinical and commercial attractiveness of bicifadine SR
    • Table 58: Global sales forecasts for other drug class ($m), 2004-14
    • Table 59: ACh receptor modulators in early-stage pipeline, 2004
    • Table 60: Bradykinin antagonists in the early-stage pipeline, 2004
    • Table 61: Vanilloid receptor antagonists in the early stage pipeline, 2004
    • Table 62: Datamonitor drug assessment parameters
  • List of Figures
    • Figure 1: Impacts on the global nociceptive pain market to 2014
    • Figure 2: Datamonitor drug assessment summary - overview
    • Figure 3: Datamonitor drug assessment summary - detail
    • Figure 4: Faces pain rating scales
    • Figure 5: Pain rating scales
    • Figure 6: The WHO 3-Step analgesic ladder
    • Figure 7: Importance of unmet needs in nociceptive pain
    • Figure 8: Opioid classification by solubility
    • Figure 9: The SF-36 assessment tool
    • Figure 10: Drug class by development stage
    • Figure 11: Nociceptive pain pipeline by delivery method
    • Figure 12: DepoDur's satisfaction of unmet needs
    • Figure 13: Research/clinical and commercial attractiveness of DepoDur
    • Figure 14: Contramid tramadol's satisfaction of unmet needs
    • Figure 15: Research/clinical and commercial attractiveness of Contramid tramadol
    • Figure 16: E-TRANS fentanyl's satisfaction of unmet needs
    • Figure 17: Research/clinical and commercial attractiveness of E-TRANS Fentanyl
    • Figure 18: CEE-04-410's satisfaction of unmet needs
    • Figure 19: Research/clinical and commercial attractiveness of CEE-04-410
    • Figure 20: Comparative strengths of key opioid drugs
    • Figure 21: Prexige's satisfaction of unmet needs
    • Figure 22: Research/clinical and commercial attractiveness of Prexige
    • Figure 23: Licofelone's satisfaction of unmet needs
    • Figure 24: Research/clinical and commercial attractiveness of licofelone
    • Figure 25: Comparative strengths of key NSAID drugs
    • Figure 26: THC monotherapy's satisfaction of unmet needs
    • Figure 27: Research/clinical and commercial attractiveness of THC monotherapy
    • Figure 28: Prialt's satisfaction of unmet needs
    • Figure 29: Research/clinical and commercial attractiveness of Prialt
    • Figure 30: Bicifadine SR's satisfaction of unmet needs
    • Figure 31: Research/clinical and commercial attractiveness of bicifadine SR
    • Figure 32: Comparative strengths of key other analgesics
    • Figure 33: Overview of Datamonitor Healthcare's forecasting approach for pipeline drugs
    • Figure 34: Example of Datamonitor drug assessment scorecard
    • Figure 35: Example of Datamonitor drug assessment graph