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Pipeline Insight: Moderate-to-Severe Acute Pain - Positive outlook for opioid-sparing analgesics
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| Inhalt der Studie: |
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 ma.....
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? [Studien Infos ausblenden] |
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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 2010 Classification of pipeline products Future outlook: current pipeline drugs will constitute almost one quarter of the acute pain market by 2019 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 2005–09 Three new products entered the moderate-to-severe acute pain market in 2009 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 2019 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 2019 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 2019 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 2019 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 2019 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 2019 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 2019 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 2019 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 2019 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 2019 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 2019 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 2019 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 2019 ARX-01 (sufentanil; AcelRx Pharmaceuticals) Drug overview Drug profile Clinical trial data SWOT analysis Datamonitor drug assessment score card for ARX-01 Clinical and commercial attractiveness Satisfaction of unmet needs Forecasts to 2019 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 2010 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 [Inhaltsverzeichnis ausblenden] |
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