R&D Trends: Acute Pain - Reformulations dominate amid paucity of innovative pipeline candidates

  • OVERVIEW
    • Catalyst
    • Summary
  • EXECUTIVE SUMMARY
    • Strategic scoping and focus
    • Datamonitor key findings
    • Related reports
  • CLINICAL PIPELINE OVERVIEW
    • Overview of the acute pain pipeline
      • The acute pain market possesses the least active pipeline of the key pain markets
      • Emerging features of the acute pain pipeline
    • Late-stage development compounds recently discontinued
      • Six candidates in the late-stage acute pain pipeline have been discontinued since November 2010
  • TARGET PRODUCT PROFILE
    • Comparator therapies
      • Fentora (fentanyl buccal tablet; Cephalon) is Datamonitor’s comparator drug for breakthrough pain
      • Astramorph PF is a suitable comparator for non-breakthrough acute pain although consensus is lacking
    • Target product profile versus current level of attainment
  • CLINICAL TRIAL DESIGN IN ACUTE PAIN
    • Clinical trials
      • Commonly used clinical trial endpoints for acute pain
    • Typical trial design
      • FDA/EMA guidance on the conduct of clinical trials for acute pain products is lacking
      • Post-operative and dental pain models are commonly used in non-breakthrough acute pain
      • Actiq clinical trial program set the standard in breakthrough pain
      • Clinical determination of abuse deterrence is unfeasible
    • Future developments in clinical trial design
      • Active-comparator and pharmacoeconomic studies are expected to grow in importance
      • Opioid post-marketing surveillance studies will be of value in demonstrating low abuse potential
  • INNOVATIVE EARLY-STAGE APPROACHES
    • Evidence of innovation is limited in the acute pain pipeline
      • Lack of translational progress poses a key barrier to innovation
      • Datamonitor regards ASIC antagonists, sigma receptor modulators and the nNOS pathway as the most innovative early stage mechanisms
  • THE FUTURE OF TREATMENT IN ACUTE PAIN
    • Fundamental changes in treatment of acute pain are unlikely in the near to mid-term
      • Opioids will continue to form the cornerstone of acute pain treatment
      • Reformulations of opioids set to expand choice of delivery methods
    • Pharmacogenomics has the potential to personalize acute pain management in the long term
  • BIBLIOGRAPHY
    • Journal papers
    • Websites
    • Datamonitor reports
  • APPENDIX
    • Contributing experts
    • Conferences attended
    • Report methodology
  • TABLES
    • Table: Late-stage R&D drug pipeline for acute pain conditions, 2011
    • Table: Early-stage R&D drug pipeline for acute pain conditions, 2011
    • Table: Recently discontinued other drugs in acute pain, 2011
    • Table: Fentora (fentanyl buccal tablet; Cephalon) – drug profile, 2011
    • Table: Pharmacokinetic parameters in healthy subjects receiving the various doses of Fentora
    • Table: Adverse events which occurred during titration of Fentora at a frequency of ≥5%
    • Table: Astramorph PF (morphine sulfate) – drug profile, 2011
    • Table: Fentora (fentanyl buccal tablet; Cephalon) versus the minimum acceptable product profile and target product profile, 2011
    • Table: Secondary endpoints employed in Phase III trials of key marketed and late-stage pipeline drugs for acute pain, 2011
    • Table: Patient populations involved in Phase III trials of key marketed and late-stage pipeline drugs for acute pain, 2011
    • Table: Summary of Nucynta’s Phase III clinical trials
    • Table: Characteristics of patients enrolled in the Farrar Actiq trial
  • FIGURES
    • Figure: Number of pipeline compounds in clinical development for three pain indications, 2011
    • Figure: Acute pain pipeline, by development phase, 2011
    • Figure: Acute pain pipeline, by mechanism of action and opioid molecule type, 2011
    • Figure: Acute pain pipeline, by route of administration, 2011
    • Figure: Acute pain pipeline, by indication under investigation, 2011
    • Figure: Pain intensity difference of Fentora (fentanyl buccal tablet; Cephalon) versus placebo over time
    • Figure: Actiq study design

Report

Published by
Datamonitor
Published on
19 Oct 2011
Product code
HC00067-006
Pages
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