Prescribing Trends in Opioids - Driven by Efficacy Advantages, Opioids to Remain the Mainstay of Breakthrough Pain Management

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Prescribing Trends in Opioids - Driven by Efficacy Advantages, Opioids to Remain the Mainstay of Breakthrough Pain Management

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Prescribing Trends in Opioids - Driven by Efficacy Advantages, Opioids to Remain the Mainstay of Breakthrough Pain Management

Summary

GBI Research, the leading business intelligence provider, has released its latest research, "Prescribing Trends in Opioids - Driven by Efficacy Advantages, Opioids to Remain the Mainstay of Breakthrough Pain Management", provides in-depth analysis of unmet needs, drivers and barriers that impact the opioids market. The report analyzes current method of practice for various indications including post-operative pain management, osteoarthritis, cancer pain, neuropathic pain and lower back pain. Treatment flow, prescription share, driver and restraints have been analyzed with respect to individual market. Trends followed in opioid abuse and regulations and various strategies applied to control are further analyzed into the report. Furthermore, the report provides competitive benchmarking for the leading products and analyzes the pipeline portfolio that shapes the global prescribing trends in opioids.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts.

Pain is a widespread problem across the world. More than 25% of the total population suffers from some clinically significant pain in a year. Since pain considerably affects day to day life, its management presents a considerable challenge for physicians. Inadequate pain control remains a major problem across the world. There is an urgent and unmet need to manage these pain related problems accurately. Currently, management of pain is not efficient due to the low rates of treatment seeking and diagnosis. In many cases such as cancer pain, the pain is under-treated in more than half of the cases that take treatment. This is primarily due to the absence of a perfect pain management solution. Pain management can be most effective only when the underlying disease conditions are cured. However, the indications studied as part of this report do not offer any effective cure. The combination of under managed pain, low awareness, and fear of addiction to some classes of pain medications is preventing people suffering pain from seeking treatment 100% of the time.

The market for pain management therapeutics is comprised of therapies such as opioids, non-steroidal anti-inflammatory drugs (NSAIDs), local anesthetics, tricyclic antidepressants and anticonvulsants. Many efficacious pain therapies are associated with several unwanted side effects. Opioids, the largest pain therapy class, cause a number of side effects, such as nausea, vomiting, constipation and somnolence, and can cause severe respiratory depression. NSAIDs can cause gastrointestinal (GI) upset, increase cardiovascular risks, and cause kidney and liver damage.

GBI Research indicates that the pain market is growing with huge potentials, despite of patent expiries and generic substitution. Rapid growth of elderly population worldwide and an escalation in the prevalence of painful conditions such as cancer and arthritis have boosted the use of opioids and pain management drugs. Despite concerns about diversion, misuse and abuse and addiction, the opioid market continues to grow with its increased use by physicians in the treatment of pain, in turn driving the market for pain management drugs.

Scope

- Analysis of various prescribing tends for pain management and key associated factors with opioids prescription.- Influencers, alternatives, formulations and different modes for opioid delivery have been analyzed.- The report further analyzes related regulations and different perspectives of Opioid prescription.- Analysis of the major prescribing sectors, including post-operative pain, osteoarthritis, cancer pain, neuropathic pain and low back pain.- Major marketed products in the opioids market are enlisted providing their mechanism of action, product description, safety issues and efficacy details. - Key drivers and barriers that have a significant impact on the market. - Coverage of pipeline molecules in various phases of drug development. Key promising molecules for pain management.

Reasons to buy

- Align your product portfolio to the markets with high growth potential.- Develop market-entry and market expansion strategies by identifying the leading therapeutic segments and geographic markets poised for strong growth.- Reinforce R&D pipelines by identifying new target mechanisms which can produce first-in-class molecules with higher efficiency and better safety.- Develop strategic initiatives by understanding the key focus areas of leading companies. - Exploit in-licensing and out-licensing opportunities by identifying products that could fill portfolio gaps.

1 Table of Contents1 Table of Contents 51.1 List of Tables 91.2 List of Figures 92 Introduction 103 Prescribing Trends in Opioids - Introduction to Opioids 113.1 World Health Organization Pain Ladder 113.2 Opioids in Pain Management 133.2.1 Opioids Remain the Mainstay of Chronic Pain Treatment 133.2.2 Opioids Classification 133.2.3 Leading Opioids in the Market 153.2.4 Adverse Effects Associated with Opioids Restrain its Prescription 164 Prescribing Trends in Opioids - Overview 174.1 Factors in Opioid Prescription 194.1.1 Alternatives to Opioid Use 204.1.2 Advantages and Disadvantages of Opioids over the Alternatives 204.2 Formulations and Mode of Delivery for Opioids 244.2.1 Route of Administration 244.2.2 Drug Dosing 254.2.3 Patients Compliance 264.3 Trends in Opioids Prescription 274.3.1 Gold Standards for Opioid Prescription 274.4 Acute and Chronic Pain 284.4.1 Use of Opioid Medications for Acute Pain 284.4.2 Use of Opioid Medications for Chronic Pain 304.5 Definition of Low, Moderate and Severe Pain 314.6 Regulations and Opioids Prescription 314.6.1 Impact of REMS on Opioids Prescription 324.6.2 FDA Regulations Regarding Opioids 374.6.3 Risk Evaluation and Mitigation Strategy 384.6.4 Physicians' Perspective of REMS 384.6.5 Differentiating physical dependence, tolerance and addiction 404.6.6 Future treatments and abuse deterrent formulations 405 Prescribing Trends in Opioids - Post-operative Pain 425.1 Current Practice 425.1.1 Treatment Flow 445.1.2 Patients Indicated for Opioid Use 445.2 Prescription Trends 465.3 Drivers and Restraints for the Opioids Market for Post-operative Pain 465.3.1 Drivers for Prescribing Trends in Post-operative Pain 475.3.2 Restraints for Prescribing Trends in Post-operative Pain 476 Prescribing Trends in Opioids - Osteoarthritis Pain 486.1 Current Practice 486.1.1 Treatment Flow 496.1.2 Patients Indicated for Opioid Use 506.2 Drivers and Restraints for the Opioids Market for Osteoarthritis Pain 516.2.1 Drivers for Prescribing Trends in Osteoarthritis Pain 526.2.2 Restraints for Prescribing Trends in Osteoarthritis Pain 527 Prescribing Trends in Opioids - Cancer Pain 537.1 Current Practice 537.1.1 Treatment Flow 547.1.2 Patients Indicated for Opioid Use 557.2 Drivers and Restraints for the Opioids Market for Cancer Pain 567.2.1 Drivers for Prescribing Trends in Cancer Pain 567.2.2 Restraints for Prescribing Trends in Cancer Pain 578 Prescribing Trends in Opioids - Neuropathic Pain 588.1 Current Practice 588.1.1 Treatment Flow 598.1.2 Patients Indicated for Opioid Use 608.2 Drivers and Restraints for the Opioids Market for Neuropathic Pain 618.2.1 Drivers for Prescribing Trends in Neuropathic Pain 618.2.2 Restraints for Prescribing Trends in Neuropathic Pain 619 Prescribing Trends in Opioids - Low Back Pain 639.1 Current Practice 639.1.1 Treatment Flow 639.1.2 Patients Indicated for Opioid Use 649.2 Drivers and Restraints for the Opioid Market for Low Back Pain 659.2.1 Drivers for Prescribing Trends in Low Back Pain 659.2.2 Restraints for Prescribing Trends in Low Back Pain 6610 Prescribing Trends in Opioids - Opioid Abuse 6710.1 Opioid Dependence 6710.2 Opioid Abuse 6810.2.1 Patient/Abuser 6810.2.2 Diversion of Opioid Prescriptions 6810.3 Regulations to Reduce the Abuse of Opioids 6910.3.1 REMS strategies 6910.4 Abuse Deterrent Formulations 7010.4.1 Embeda 7010.4.2 Remoxy 7010.4.3 Oxecta 7111 Prescribing Trends in Opioids - Major Drugs 7211.1 Duragesic (fentanyl) 7211.1.1 Mechanism of Action 7211.1.2 Product Description: 7211.1.3 Safety Issues 7211.2 Ultram ER (tramadol hydrochloride) 7311.2.1 Mechanism of Action 7311.2.2 Product Description 7311.2.3 Safety Issues 7311.2.4 Efficacy Details 7311.3 Pavinal-Atropine (oxycodone hydrochloride hydrate + hydrocotarnine hydrochloride + atropine sulfate) 7411.3.1 Mechanism of Action 7411.3.2 Product Description: 7411.3.3 Safety Issues 7411.4 OxyContin (oxycodone hydrochloride) 7511.4.1 Mechanism of Action 7511.4.2 Product Description 7511.4.3 Safety Issues 7511.4.4 Efficacy Details 7511.5 Vicodin (hydrocodone bitartrate + acetaminophen) 7611.5.1 Mechanism of Action 7611.5.2 Product Description 7611.5.3 Safety Issues 7611.6 Buprelor (buprenorphine) 7611.6.1 Mechanism of Action 7611.6.2 Product Description 7611.6.3 Safety Issues 7711.7 Dividol (viminolo parahydroxybenzoate) 7711.7.1 Mechanism of Action 7711.7.2 Product Description: 7711.7.3 Safety Issues 7711.8 Filnarine SR (morphine sulfate pentahydrate) 7811.8.1 Mechanism of Action 7811.8.2 Product Description 7811.8.3 Safety Issues 7811.9 Nalbuphine (nalbuphine hydrochloride) 7811.9.1 Mechanism of Action 7811.9.2 Product Description 7811.9.3 Safety Issues 7911.10 Spasmoplus (propyphenazone) 7911.10.1 Mechanism of Action 7911.10.2 Product Description 7911.10.3 Safety Issues 7911.11 Mypaid (dihydrocodeine) 7911.11.1 Mechanism of Action 7911.11.2 Product Description 7911.11.3 Safety Issues 8011.12 Yantil (tapentadol hydrochloride) 8011.12.1 Mechanism of Action 8011.12.2 Product Description 8011.12.3 Safety Issues 8011.13 Nucynta (tapentadol hydrochloride) 8111.13.1 Mechanism of Action 8111.13.2 Product Description 8111.13.3 Safety Issues 8111.13.4 Efficacy Details 8212 Prescribing Trends in Opioids - Pipeline Analysis 8312.1 Introduction 8312.2 Profiles of Key Late-Stage Drugs in the Opioids Market 8412.2.1 Fentanyl Taifun - AKELA Pharma Inc. 8412.2.2 Fentanyl Sublingual Spray - Insys Therapeutics, Inc. 8512.2.3 Oxycodone Hydrochloride - Mundipharma International Limited 8512.2.4 CEP-33237 – Teva Pharmaceuticals (Cephalon, Inc.) 8512.2.5 ELI-216 - Elite Pharmaceuticals, Inc. 8512.2.6 ALO-02 (Oxycodone-naltrexone) 8612.3 Price Premium on New Dose Forms 8712.4 Price Premium on Abuse Deterrent Formulations in the Pipeline 8713 Prescribing Trends in Opioids - Appendix 8813.1 Market Definitions 8813.2 Abbreviations 8813.3 Sources 8813.4 Research Methodology 8913.4.1 Coverage 8913.4.2 Secondary Research 9013.4.3 Primary Research 9013.5 Pipeline Analysis 9013.5.1 Expert Panel Validation 9113.6 Contact Us 9113.7 Disclaimer 91

List of Tables

1.1 List of TablesTable 1: Prescribing Trends in Opioids, Key Brands Affected by REMS 35Table 2: Prescribing Trends in opioids, List of Approved REMS 39

List of Figures

1.2 List of FiguresFigure 1: Prescribing Trends in Opioids, WHO Three Step Ladder for Pain Management, 2011 11Figure 2: Prescribing Trends in Opioids, Adverse Effects, 2011 12Figure 3: Prescribing Trends in Opioids, Classification of Opioids 14Figure 4: Prescribing Trends in Opioids, Treatment of Acute Pain 28Figure 5: Prescribing Trends in Opioids, Contraindications and Relative Contraindications in the Treatment of Acute Pain using Schedule II, III, IV Drugs 29Figure 6: Prescribing Trends in Opioids, Patient Assessment for Chronic Pain Management using Opioids 30Figure 7: Prescribing Trends in opioids, Components of REMS 33Figure 8: Prescribing Trends in Opioids, REMS, Implications for Patients 34Figure 9: Prescribing Trends in Opioids, Number of Emergency Department Visits due to Drug Abuse in the US, 2004 and 2008 36Figure 10: Prescribing Trends in Opioids, New REMS Proposal for Opioid Prescription, 2010 37Figure 11: Prescribing Trends in Opioids, Drugs Used in Post-operative Pain Management 43Figure 12: Prescribing Trends in Opioids, Post-operative Pain, Treatment Flow Algorithm 44Figure 13: Prescribing Trends in Opioids, Prescription Population Indicated for Opioid and Non-Opioid Use, Post-operative Pain (%), 2011 44Figure 14: Prescribing Trends in Opioids, Post-operative Pain, Patient Share (%), 2011 45Figure 15: Prescribing Trends in Opioids, Post-operative Pain, Drivers and Restraints 46Figure 16: Prescribing Trends in Opioids, Osteoarthritis Pain, Treatment Flow Algorithm 49Figure 17: Prescribing Trends in Opioids, Prescription Population Indicated for Opioid and Non-Opioid Use, Osteoarthritis Pain (%), 2011 50Figure 18: Prescribing Trends in Opioids, Osteoarthritis Pain, Patients Share (%), 2011 50Figure 19: Prescribing Trends in Opioids, Osteoarthritis Pain, Drivers and Restraints 51Figure 20: Prescribing Trends in Opioids, Cancer Pain, Treatment Flow Algorithm 54Figure 21: Prescribing Trends in Opioids, Prescription Population Indicated for Opioid and Non-Opioid Use, Cancer Pain (%), 2011 55Figure 22: Prescribing Trends in Opioids, Cancer Pain, Patients Share (%), 2011 55Figure 23: Prescribing Trends in Opioids, Cancer Pain, Drivers and Restraints 56Figure 24: Prescribing Trends in Opioids, Neuropathic Pain, Treatment Flow Algorithm 59Figure 25: Prescribing Trends in Opioids, Prescription Population Indicated for Opioid and Non-Opioid Use, Neuropathic Pain (%), 2011 60Figure 26: Prescribing Trends in Opioids, Neuropathic Pain, Patients Share (%), 2011 60Figure 27: Prescribing Trends in Opioids, Neuropathic Pain, Drivers and Restraints, 2010 61Figure 28: Prescribing Trends in Opioids, Low Back Pain, Treatment Flow Algorithm 63Figure 29: Prescribing Trends in Opioids, Prescription Population Indicated for Opioid and Non-Opioid Use, Low Back Pain (%), 2011 64Figure 30: Prescribing Trends in Opioids, Low Back Pain, Patient Share (%), 2011 64Figure 31: Prescribing Trends in Opioids, Low Back Pain, Drivers and Restraints, 2010 65Figure 32: Prescribing Trends in Opioids, Global, Opioid R&D Pipeline by Indication (%), March 2010 83Figure 33: Prescribing Trends in Opioids, Global, R&D Pipeline by Phase (%), March 2010 84

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