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Pipeline Insight: Nociceptive Pain - Safety Profile Uppermost in Crowded Market
Datamonitor, Oct 2004, Pages: 264

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CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Our 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

Our 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 III

Patient potential

Marketing

Satisfaction of unmet needs

Forecasts to 2014

Drug assessment summary

Contramid tramadol

Drug overview

Clinical trial data

Phase III

Phase II

Patient potential

Marketing

Satisfaction of unmet needs

Forecasts to 2014

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

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

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) 166

Drug overview

Clinical trial data

Patient potential

Marketing

Satisfaction of unmet needs

Forecasts to 2014

Drug assessment summary

Licofelone

Drug overview

Clinical trial data

Patient potential

Marketing

Satisfaction of unmet needs

Forecasts to 2014

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

Drug assessment summary

SAB-378

Other analgesics

Prialt (ziconotide)

Drug overview

Clinical trial data

Patient potential

Marketing

Satisfaction of unmet needs

Forecasts to 2014

Drug assessment summary

Bicifadine SR

Drug overview

Clinical trial data

Patient potential

Marketing

Satisfaction of unmet needs

Forecasting to 2014

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

Drug assessment summary

APPENDIX B

Our Healthcare

Our Healthcare research and analysis methodologies

Our Healthcare therapy area capabilities

About the CNS analysis team

Key therapy team members

Lynda Lynch, Director CNS

David Abramson, Therapeutic Lead Consultant

Disclaimer




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