1. Prescribing Trends in Opioids - Driven by Efficacy Advantages,
Opioids to Remain the Mainstay of Breakthrough Pain
Management
Report Details:
Published:May 2012
No. of Pages: 91
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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
2. 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
3. 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.
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Major points covered in Table of Contents of this report include
1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 9
1.2 List of Figures 9
2 Introduction 10
3 Prescribing Trends in Opioids - Introduction to Opioids 11
3.1 World Health Organization Pain Ladder 11
3.2 Opioids in Pain Management 13
3.2.1 Opioids Remain the Mainstay of Chronic Pain Treatment 13
3.2.2 Opioids Classification 13
3.2.3 Leading Opioids in the Market 15
3.2.4 Adverse Effects Associated with Opioids Restrain its Prescription 16
4 Prescribing Trends in Opioids - Overview 17
4.1 Factors in Opioid Prescription 19
4.1.1 Alternatives to Opioid Use 20
4.1.2 Advantages and Disadvantages of Opioids over the Alternatives 20
4.2 Formulations and Mode of Delivery for Opioids 24
4.2.1 Route of Administration 24
4.2.2 Drug Dosing 25
4.2.3 Patients Compliance 26
4.3 Trends in Opioids Prescription 27
4.3.1 Gold Standards for Opioid Prescription 27
4.4 Acute and Chronic Pain 28
4.4.1 Use of Opioid Medications for Acute Pain 28
4.4.2 Use of Opioid Medications for Chronic Pain 30
4.5 Definition of Low, Moderate and Severe Pain 31
4.6 Regulations and Opioids Prescription 31
4.6.1 Impact of REMS on Opioids Prescription 32
4.6.2 FDA Regulations Regarding Opioids 37
4.6.3 Risk Evaluation and Mitigation Strategy 38
4.6.4 Physicians’ Perspective of REMS 38
4.6.5 Differentiating physical dependence, tolerance and addiction 40
4.6.6 Future treatments and abuse deterrent formulations 40
4. 5 Prescribing Trends in Opioids - Post-operative Pain 42
5.1 Current Practice 42
5.1.1 Treatment Flow 44
5.1.2 Patients Indicated for Opioid Use 44
5.2 Prescription Trends 46
5.3 Drivers and Restraints for the Opioids Market for Post-operative Pain 46
5.3.1 Drivers for Prescribing Trends in Post-operative Pain 47
5.3.2 Restraints for Prescribing Trends in Post-operative Pain 47
6 Prescribing Trends in Opioids - Osteoarthritis Pain 48
6.1 Current Practice 48
6.1.1 Treatment Flow 49
6.1.2 Patients Indicated for Opioid Use 50
6.2 Drivers and Restraints for the Opioids Market for Osteoarthritis Pain 51
6.2.1 Drivers for Prescribing Trends in Osteoarthritis Pain 52
6.2.2 Restraints for Prescribing Trends in Osteoarthritis Pain 52
7 Prescribing Trends in Opioids - Cancer Pain 53
7.1 Current Practice 53
7.1.1 Treatment Flow 54
7.1.2 Patients Indicated for Opioid Use 55
7.2 Drivers and Restraints for the Opioids Market for Cancer Pain 56
7.2.1 Drivers for Prescribing Trends in Cancer Pain 56
7.2.2 Restraints for Prescribing Trends in Cancer Pain 57
8 Prescribing Trends in Opioids - Neuropathic Pain 58
8.1 Current Practice 58
8.1.1 Treatment Flow 59
8.1.2 Patients Indicated for Opioid Use 60
8.2 Drivers and Restraints for the Opioids Market for Neuropathic Pain 61
8.2.1 Drivers for Prescribing Trends in Neuropathic Pain 61
8.2.2 Restraints for Prescribing Trends in Neuropathic Pain 61
9 Prescribing Trends in Opioids - Low Back Pain 63
9.1 Current Practice 63
9.1.1 Treatment Flow 63
9.1.2 Patients Indicated for Opioid Use 64
9.2 Drivers and Restraints for the Opioid Market for Low Back Pain 65
9.2.1 Drivers for Prescribing Trends in Low Back Pain 65
9.2.2 Restraints for Prescribing Trends in Low Back Pain 66
10 Prescribing Trends in Opioids - Opioid Abuse 67
10.1 Opioid Dependence 67
10.2 Opioid Abuse 68
10.2.1 Patient/Abuser 68
10.2.2 Diversion of Opioid Prescriptions 68
6. 11.8.3 Safety Issues 78
11.9 Nalbuphine (nalbuphine hydrochloride) 78
11.9.1 Mechanism of Action 78
11.9.2 Product Description 78
11.9.3 Safety Issues 79
11.10 Spasmoplus (propyphenazone) 79
11.10.1 Mechanism of Action 79
11.10.2 Product Description 79
11.10.3 Safety Issues 79
11.11 Mypaid (dihydrocodeine) 79
11.11.1 Mechanism of Action 79
11.11.2 Product Description 79
11.11.3 Safety Issues 80
11.12 Yantil (tapentadol hydrochloride) 80
11.12.1 Mechanism of Action 80
11.12.2 Product Description 80
11.12.3 Safety Issues 80
11.13 Nucynta (tapentadol hydrochloride) 81
11.13.1 Mechanism of Action 81
11.13.2 Product Description 81
11.13.3 Safety Issues 81
11.13.4 Efficacy Details 82
12 Prescribing Trends in Opioids - Pipeline Analysis 83
12.1 Introduction 83
12.2 Profiles of Key Late-Stage Drugs in the Opioids Market 84
12.2.1 Fentanyl Taifun - AKELA Pharma Inc. 84
12.2.2 Fentanyl Sublingual Spray - Insys Therapeutics, Inc. 85
12.2.3 Oxycodone Hydrochloride - Mundipharma International Limited 85
12.2.4 CEP-33237 – Teva Pharmaceuticals (Cephalon, Inc.) 85
12.2.5 ELI-216 - Elite Pharmaceuticals, Inc. 85
12.2.6 ALO-02 (Oxycodone-naltrexone) 86
12.3 Price Premium on New Dose Forms 87
12.4 Price Premium on Abuse Deterrent Formulations in the Pipeline 87
13 Prescribing Trends in Opioids - Appendix 88
13.1 Market Definitions 88
13.2 Abbreviations 88
13.3 Sources 88
13.4 Research Methodology 89
13.4.1 Coverage 89
13.4.2 Secondary Research 90
13.4.3 Primary Research 90
7. 13.5 Pipeline Analysis 90
13.5.1 Expert Panel Validation 91
13.6 Contact Us 91
13.7 Disclaimer 91
1.1 List of Tables
Table 1: Prescribing Trends in Opioids, Key Brands Affected by REMS 35
Table 2: Prescribing Trends in opioids, List of Approved REMS 39
1.2 List of Figures
Figure 1: Prescribing Trends in Opioids, WHO Three Step Ladder for Pain Management, 2011 11
Figure 2: Prescribing Trends in Opioids, Adverse Effects, 2011 12
Figure 3: Prescribing Trends in Opioids, Classification of Opioids 14
Figure 4: Prescribing Trends in Opioids, Treatment of Acute Pain 28
Figure 5: Prescribing Trends in Opioids, Contraindications and Relative Contraindications in the
Treatment of Acute Pain using Schedule II, III, IV Drugs 29
Figure 6: Prescribing Trends in Opioids, Patient Assessment for Chronic Pain Management using
Opioids 30
Figure 7: Prescribing Trends in opioids, Components of REMS 33
Figure 8: Prescribing Trends in Opioids, REMS, Implications for Patients 34
Figure 9: Prescribing Trends in Opioids, Number of Emergency Department Visits due to Drug
Abuse in the US, 2004 and 2008 36
Figure 10: Prescribing Trends in Opioids, New REMS Proposal for Opioid Prescription, 2010 37
Figure 11: Prescribing Trends in Opioids, Drugs Used in Post-operative Pain Management 43
Figure 12: Prescribing Trends in Opioids, Post-operative Pain, Treatment Flow Algorithm 44
Figure 13: Prescribing Trends in Opioids, Prescription Population Indicated for Opioid and Non-
Opioid Use, Post-operative Pain (%), 2011 44
Figure 14: Prescribing Trends in Opioids, Post-operative Pain, Patient Share (%), 2011 45
Figure 15: Prescribing Trends in Opioids, Post-operative Pain, Drivers and Restraints 46
Figure 16: Prescribing Trends in Opioids, Osteoarthritis Pain, Treatment Flow Algorithm 49
Figure 17: Prescribing Trends in Opioids, Prescription Population Indicated for Opioid and Non-
Opioid Use, Osteoarthritis Pain (%), 2011 50
Figure 18: Prescribing Trends in Opioids, Osteoarthritis Pain, Patients Share (%), 2011 50
Figure 19: Prescribing Trends in Opioids, Osteoarthritis Pain, Drivers and Restraints 51
Figure 20: Prescribing Trends in Opioids, Cancer Pain, Treatment Flow Algorithm 54
Figure 21: Prescribing Trends in Opioids, Prescription Population Indicated for Opioid and Non-
Opioid Use, Cancer Pain (%), 2011 55
Figure 22: Prescribing Trends in Opioids, Cancer Pain, Patients Share (%), 2011 55
Figure 23: Prescribing Trends in Opioids, Cancer Pain, Drivers and Restraints 56
Figure 24: Prescribing Trends in Opioids, Neuropathic Pain, Treatment Flow Algorithm 59
Figure 25: Prescribing Trends in Opioids, Prescription Population Indicated for Opioid and Non-
8. Opioid Use, Neuropathic Pain (%), 2011 60
Figure 26: Prescribing Trends in Opioids, Neuropathic Pain, Patients Share (%), 2011 60
Figure 27: Prescribing Trends in Opioids, Neuropathic Pain, Drivers and Restraints, 2010 61
Figure 28: Prescribing Trends in Opioids, Low Back Pain, Treatment Flow Algorithm 63
Figure 29: Prescribing Trends in Opioids, Prescription Population Indicated for Opioid and Non-
Opioid Use, Low Back Pain (%), 2011 64
Figure 30: Prescribing Trends in Opioids, Low Back Pain, Patient Share (%), 2011 64
Figure 31: Prescribing Trends in Opioids, Low Back Pain, Drivers and Restraints, 2010 65
Figure 32: Prescribing Trends in Opioids, Global, Opioid R&D Pipeline by Indication (%), March
2010 83
Figure 33: Prescribing Trends in Opioids, Global, R&D Pipeline by Phase (%), March 2010 84
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