Commercial and Pipeline Insight: Opioids - Short acting and anti-abuse technologies set to fragment and grow the market

CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Contributing experts 3
Datamonitor insight into the opioid market 4
Related reports 6

CHAPTER 2 MARKET OVERVIEW AND POTENTIAL 8
Market overview and pain definition 9
Definition of opioid market 9
Market potential 10
Epidemiology of pain 10
Incidence 10
The burden of pain on every day life 10
Commonly-reported pain conditions 10
Definition of pain 11
Nociceptive pain 11
Neuropathic pain 12
Types of pain treated with opioids 13
Diagnosis of pain 14
Treatment of pain 15
Acute pain and cancer pain 15
Chronic non-cancer pain 16
Unmet need in pain treatment 17
Need to reduce the abuse and overdosing potential of opioids 18
Need to minimize opioid-related adverse events 19
Improved short-acting opioids 20
Current market value and future market forecasts 26
Current market dynamics 26
OxyContin dominates the opioid market 26
The US generated more revenue from opioid therapies than the EU and Japan combined 27
The opioid market is set to grow throughout the forecast period 29
Short-acting opioids-large growth driver 30
Anti-abuse reformulations take share from OxyContin 32
Generics are ever present 33

CHAPTER 3 BRAND DYNAMICS AND LEADING COMPARATOR THERAPIES 34
Marketed brands overview 35
Short-acting opioid brands 36
Actiq (fentanyl oral transmucosal) 36
Drug overview 36
Forecasts to 2017 36
SWOT analysis 38
Clinical trial data 38
Fentora 40
Drug overview 40
Forecasts to 2017 40
SWOT analysis 44
Patient potential 44
Marketing factors 44
Clinical trial data 45
Long-acting opioid brand 47
OxyContin (oxycodone HCl controlled-release) 47
Drug overview 47
Forecasts to 2017 48
SWOT analysis 51
Clinical trial data 51
Kadian (morphine sulfate XR) 55
Drug overview 55
Forecasts to 2017 55
SWOT analysis 57
Clinical trial data 57
Avinza (morphine sulfate XR) 59
Drug overview 59
Forecasts to 2017 59
SWOT analysis 61
Clinical trial data 61
Duragesic (fentanyl transdermal patch) 63
Drug overview 63
Forecasts to 2017 64
SWOT analysis 66
Clinical trial data 66
Opana 68
Drug overview 68
Forecasts to 2017 69
SWOT analysis 70
Clinical trial data 70

CHAPTER 4 FORECAST ANALYSIS 72
Key events 73
New product launches 74
Key drug launch assumptions 74
Product launches in Japan 75
Patent expiries 76
Data definitions, limitations and assumptions 76
Standard units 76
Japanese market data 76
Derivation of sales forecasts and pricing trends 77
Forecast methodology 77

CHAPTER 5 STRATEGIES FOR SUCCESS 78
Broaden customer base with key additional indications 79
Back pain 80
Postoperative pain 80
Neuropathic pain 81
Osteoarthritis 81
Refractory migraine 82
Opportunities for specialized niche companies to enter the market 82
Delivery reformulation 83
Anti-abuse technologies 86

CHAPTER 6 PIPELINE OVERVIEW-R&D DYNAMICS AND APPROACH 87
Pipeline overview 88
Classification of pipeline products 91
Majority of pipeline products are reformulations of existing opioids 91
Short-acting opioids 91
Oral transmucosal opioids 91
Intranasal opioids 92
Oral inhaled opioids 92
Long-acting opioids 93
Oral opioids 93
Subcutaneous opioids 93
Transdermal opioids 93
Clinical trial design 94
Actiq clinical trials set the standard 94
Actiq pivotal trial overview 94
Clinical trial endpoints in pain 100
Primary endpoints: the brief pain inventory is often used to assess pain in cancer patients 100
Secondary endpoints: economic and quality-of-life measures are important 100

CHAPTER 7 SHORT-ACTING OPIOID DRUG ANALYSIS & FORECASTS 102
Late-stage short-acting pipeline overview 103
Fentanyl based formulations 105
Rapinyl (sublingual) 106
Drug overview 106
Forecasts to 2017 106
Marketing potential 109
Patient potential 111
Satisfaction of unmet needs 111
Clinical trial data 112
BEMA fentanyl (buccal) 112
Drug overview 112
Forecasts to 2017 113
Marketing factors 116
Patient potential 117
Satisfaction of unmet needs 118
Clinical trial data 118
Instanyl (intranasal) 119
Drug overview 119
Forecasts to 2017 119
Marketing potential 121
Patient potential 122
Satisfaction of unmet needs 122
Clinical trial data 123
Nasalfent (intranasal) 123
Drug overview 123
Forecasts to 2017 123
Marketing potential 125
Patient potential 126
Satisfaction of unmet needs 126
Clinical data 126
AD-923 (sublingual spray) 127
Drug overview 127
Ongoing clinical trial program 128
Forecasts to 2017 128
HFT-290 (transdermal) 130
Morphine-based formulations 131
Rylomine (intranasal) 131
Drug overview 131
Forecasts to 2017 131
Marketing potential 133
Patient potential 134
Satisfaction of unmet needs 134
Clinical trial data 134
Buprenorphine based formulations 135
V1003 (intranasal) 135
Drug overview 135
Forecasts to 2017 136
Marketing potential 138
Patient potential 138
Clinical trial data 139
BEMA LA (buccal) 140
Drug overview 140
Clinical trial data 140
Drugs on hold 141
Taifun (inhaled) 141
Drug overview 141
Marketing potential 141
Patient potential 142
Satisfaction of unmet needs 143
Clinical trial data 143
AeroLEF (inhaled) 144
Drug overview 144
Marketing potential 145
Patient potential 146
Satisfaction of unmet needs 146
Clinical trial data 147

CHAPTER 8 LONG-ACTING OPIOID DRUG ANALYSIS & FORECASTS 149
Late-stage long-acting pipeline overview 150
Oxycodone based formulations 153
Remoxy (oxycodone) 153
Drug overview 153
Forecasts to 2017 154
Marketing potential 156
Patient potential 157
Satisfaction of unmet needs 157
Clinical trial data 157
Oxytrex (oxycodone and naltrexone) 158
Drug overview 158
Forecasts to 2017 158
Marketing potential 161
Patient potential 161
Satisfaction of unmet needs 162
Ongoing clinical trial program 162
ELI-216 (naltrexone hydrochloride, oxycodone) 162
Drug overview 162
Marketing potential 163
Patient potential 163
Ongoing clinical trial program 163
Acurox/OxyADF (oxycodone) tablet 164
Drug overview 164
Clinical trial data 165
Morphine-based formulations 167
Embeda (morphine sulfate, naltrexone hydrochloride) 167
Drug overview 167
Forecasts to 2017 167
Marketing potential 170
Patient potential 170
Satisfaction of unmet needs 171
Clinical trial data 171
Morphine-6-glucuronide (M6G) 171
Drug overview 171
Forecasts to 2017 172
Marketing potential 173
Patient potential 174
Clinical trial data 174
Egalet morphine (morphine) 176
EpiCept MP/DP (morphine, lidocaine) 177
Drug overview 177
Tramadol-based formulations 177
Tapentadol 177
Drug overview 177
Forecasts to 2017 178
Marketing potential 180
Patient potential 180
Clinical trial data 181
Tramadol ER 182
Drug overview 182
Forecasts to 2017 182
Clinical trial data 182
NS-315 (tramadol hydrochloride) 183
Drug overview 183
BVF-146 (tramadol in combination with NSAID) 183
Other 184
Ionsys (transdermal delivery system) 184
Drug overview 184
Forecasts to 2017 184
Marketing potential 185
Patient potential 185
Clinical trial data 186
Sufentanil patch 188
Drug overview 188
Forecasts to 2017 188
Clinical trial data 189
Vicodin CR 190
Drug overview 190
Forecasts to 2017 190
Hydromorphone nasal spray 192
Drug overview 192