Pipeline Insight: Moderate-to-Severe Acute Pain - Positive outlook for opioid-sparing analgesics
Datamonitor, November 2010, Pages: 297
Introduction
The treatment of moderate to severe acute pain is dominated by opioids. While they offer excellent pain relief, they come with undesirable side effects and abuse potential. The future market is highly receptive to better tolerated opioids and analgesics with opioid-sparing effects. Opportunities also exist in the post-operative and breakthrough pain segments for rapid acting delivery technologies.
Features and benefits
- Analysis of patient segmentation, epidemiology, current treatment approaches, the patient acquisition process and clinical unmet needs
- Assessment of key pipeline agents in late stage development for breakthrough, post-operative, and general moderate to severe acute pain treatment
- Breakdown of historic (2005-09) and future (2010-19) prescription sales across the seven major markets consisting of the US, Japan, and 5EU.
- Discussion of pipeline trends, R&D strategies, and key development companies
Highlights
- The value of the moderate-to-severe acute pain market across the seven major markets was $3.9 billion in 2009 and is forecast to reach $6.1 billion by 2019. Current pipeline drugs are expected to drive future market growth and will constitute almost one quarter of the market by 2019.
- The prevailing strategy employed by developers of acute pain treatments is that of reformulating alternative delivery methods of established opioid molecules. Although this is less risk with this strategy the rewards are not substantial, particularly in this cost competitive market environment.
- The market is receptive to analgesics offering fewer adverse events than opioids and have opioid-sparing effects. Several pipeline products appear promising, such as QRx Pharma's dual opioid combination MoxDuo and Nycomed/Durect's long acting bupivacaine injection Posidur. However, convincing clinical data is needed to aid market penetration.
Your key questions answered
- Who will be the winners and losers in the future breakthrough cancer pain market?
- What are the commercial prospects for non-opioid analgesics, such as ketamine and bupivacaine, targeting moerate to severe acute pain?
- What are the most promising drug candidates in development for the potential treatment of post-operative pain?
Executive Summary
Strategic scoping and focus
Datamonitor insight into the moderate-to-severe acute pain market
Related reports
Upcoming related reports
OVERVIEW
Catalyst
Summary
1. PIPELINE OVERVIEW AND DYNAMICS
Key findings
Pipeline overview
Late-stage candidates dominate the acute pain pipeline in
Classification of pipeline products
Future outlook: current pipeline drugs will constitute almost one quarter of the acute pain market by
Key companies involved in the acute pain pipeline
Small, specialist pharmaceutical companies dominate the moderate-to-severe acute pain pipeline
Key R&D company strategies
Reformulations: alternative delivery methods of established molecules are highly prevalent in the pipeline
2. EPIDEMIOLOGY
Key findings
Definition of acute pain
Duration
Severity
Etiology
Patient segmentation
Breakthrough pain
Post-operative pain
Epidemiology
There is a dearth of studies examining the prevalence of moderate-to-severe acute pain
Breakthrough cancer pain
Breakthrough pain in non-malignant conditions
Post-operative pain
Assessment of acute pain
3. MARKET OVERVIEW
Key findings
Current treatment options for acute pain
Analgesics span multiple drug classes
Management of acute pain by severity
Current comparator therapies
Fentora (fentanyl buccal tablet; Cephalon) is Datamonitor’s comparator drug for breakthrough pain
Percocet (oxycodone/acetaminophen, Endo Pharmaceuticals) is a suitable comparator although consensus among key opinion leaders is lacking
Current market overview
Market definition for this report
Moderate-to-seven acute pain market exhibited steady growth in the seven major markets over 2005–
Three new products entered the moderate-to-severe acute pain market in
Clinical unmet need in moderate-to-severe acute pain
Reduction in opioid-related adverse events
Improved treatments for breakthrough pain
Improvement in the management of post-operative pain
Reduction in the abuse potential of opioids
Environmental unmet need in acute pain
Healthcare professionals require greater training in pain assessment
Standardized diagnosis and assessment tools for breakthrough pain
4. R&D APPROACH
Key findings
Clinical trial design in acute pain
A variety of endpoints are used for acute pain trials
Moderate to severe (non-breakthrough) acute pain: Post-operative and dental pain models are commonly used
Breakthrough pain: Actiq clinical trial program set the standard
Clinical determination of abuse deterrence is unfeasible
Key opinion leaders believe that the risk evaluation and mitigation strategies of the FDA have the potential to shift prescribing patterns
5. PIPELINE ANALYSIS & FORECASTS: BREAKTHROUGH PAIN
Key findings
Overview of breakthrough pain pipeline
Pipeline summary
Comparative forecasts
PecFent (fentanyl nasal spray; Archimedes)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for PecFent
Clinical and commercial attractiveness
Satisfaction of unmet needs
Forecasts to
Fentanyl SL (fentanyl sublingual spray; Insys Therapeutics)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for Fentanyl SL
Clinical and commercial attractiveness
Satisfaction of unmet needs
Forecasts to
Fentanyl TAIFUN (fentanyl inhalation spray; Akela Pharma/Janssen Pharmaceutica/Teikoku Seiyaku)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for Fentanyl TAIFUN
Clinical and commercial attractiveness
Satisfaction of unmet needs
Forecasts to
Fastanix (NAL1239, fentanyl orally dissolving film; NAL Pharmaceuticals)
Drug overview
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for Fastanix
Clinical and commercial attractiveness
Satisfaction of unmet needs
Forecasts to
ARX-02 (sublingual sufentanil; AcelRx Pharmaceuticals)
Drug overview
Clinical trial data
Clinical and commercial attractiveness
6. PIPELINE ANALYSIS & FORECASTS: POST-OPERATIVE AND ACUTE PAIN
Key findings
Overview of post-operative and acute pain pipeline
Candidates within the non-breakthrough pain segment of the pipeline are characterized by a greater variety of mechanisms of action
Comparative forecasts
Acurox (oxycodone with niacin; Acura/King Pharmaceuticals)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for Acurox without niacin
Clinical and commercial attractiveness
Satisfaction of unmet needs
Forecasts to
DDS-06C (tramadol and acetaminophen; Labopharm)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for DDS-06C
Clinical and commercial attractiveness
Satisfaction of unmet needs
Forecasts to
Lyrica (pregabalin; Pfizer)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for Lyrica
Clinical and commercial attractiveness
Satisfaction of unmet needs
Forecasts to
Rylomine (intranasal morphine; Javelin Pharmaceuticals/Archimedes)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for Rylomine
Clinical and commercial attractiveness
Satisfaction of unmet needs
Forecasts to
Ereska (intranasal ketamine; Javelin Pharmaceuticals)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for Ereska
Clinical and commercial attractiveness
Satisfaction of unmet needs
Forecasts to
MoxDuo IR (morphine and oxycodone; QRxPharma)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for MoxDuo IR
Clinical and commercial attractiveness
Satisfaction of unmet needs
Forecasts to
Exparel (bupivacaine hydrochloride; Pacira Pharmaceuticals)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for Exparel
Clinical and commercial attractiveness
Satisfaction of unmet needs
Forecasts to
M6G (morphine 6-glucuronide; PAION)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for M6G
Clinical and commercial attractiveness
Satisfaction of unmet needs
Forecasts to
Posidur (Bupivacaine, Nycomed/Durect)
Drug overview
Drug profile
Clinical trial data
Datamonitor drug assessment score card for Posidur
SWOT analysis
Clinical and commercial attractiveness
Satisfaction of unmet needs
Forecasts to
ARX-01 (sufentanil; AcelRx Pharmaceuticals)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for ARX-
Clinical and commercial attractiveness
Satisfaction of unmet needs
Forecasts to
Non-forecasted products in development for post-operative and acute pain
ADL5859 (Adolor/Pfizer)
ARRY797 (Array BioPharma)
NDL-101 (NeuroDiscovery)
CR845 (Cara Therapeutics)
Xen2174 (Xenome)
CollaRx Bupivacaine Implant (bupivacaine; Innocoll)
BEMA Buprenorphine (Buprenorphine buccal film, BioDelivery Sciences)
Hydromorphone nasal spray (Ikano Therapeutics)
NCE1 (Grünenthal)
Recently discontinued products
YM Biosciences terminated development of AeroLEF—a respiratory inhaler formulation of fentanyl—in June
BIBLIOGRAPHY
Books and journal papers
Websites
Datamonitor reports
APPENDIX
Forecasting assumptions
New product launches
Methodology
Datamonitor forecast methodology
Product forecasts
Definition of a standard unit
Exchange rates
Country group definitions
Datamonitor drug assessment scorecard
Contributing experts
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