Evolution in the Pain Therapy Drugs Market: Nociceptive and Neuropathic Drug Development

NEW YORK, Jan. 10, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Evolution in the Pain Therapy Drugs Market: Nociceptive and Neuropathic Drug Development

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Pain Therapy Drugs Market

As the market evolves over the next decade current market leaders will lose patent expiry and become subject to generic competition. What's in the pipeline and which companies and products will prosper?

Pain affects around 1.5 billion people worldwide. In most cases, pain is temporary and easily treated with commonly available analgesics. For some people, however, pain is a debilitating, chronic condition. In Europe, an estimated 20% of the population suffers from chronic pain. As the population ages, the number of people with chronic pain is increasing, particularly from conditions such as osteoarthritis. Chronic pain is also associated with cancer. An estimated 30% of all cancer patients are in pain with the proportion more than doubling among people with late-stage cancer. In recent years, drug development in pain therapy has been focused mainly on reformulations of existing therapies and alternative modes of drug delivery in order to improve the safety and efficacy of existing drug groups.Drugs of the futureThis report identifies 75 agents in clinical development for pain indications, of which 26 are in development for neuropathic pain. Among these, six are specifically targeting postherpetic neuralgia. Other indications specified, include: diabetic peripheral neuropathy, central neuropathic pain due to spinal cord injury or multiple sclerosis (MS), neuropathic pain in cancer, lumbosacral radiculopathy, and painful neuropathies affecting AIDS patients. Nociceptive pain indications being targeted by developers,include: osteoarthritis pain and chronic low back pain.

This report answers key questions on:

What is the current clinical understanding of pain? What is the status of, and commercial prospects for, currently available pain therapies? What drugs are in the pipeline and what is their status? Which companies are set to win, and which to lose, as the pain sector develops over the next 5 years?

While highly competitive, pain remains a sector of high unmet clinical need with excellent opportunities in niche markets

While the pain market is fragmented and highly competitive, it remains an area of high unmet need as current therapies are often less than effective and/or have undesirable side-effects. A number of new drugs are poised to take market share, with Palexia/Nucynta (tapentadol) widely tipped to be among the up and coming market leaders. As the market continues to evolve over the next decade, the current market leaders will lose patent expiry and become subject to generic competition and consequent price erosion. It is generally agreed that sales of novel treatments are unlikely to entirely replace the revenue lost following patent expiry of the current top five. However, there will be opportunities in underserved niche market segments, particularly neuropathic pain, which typically fails to respond adequately to conventional analgesics.

Lessons in OTC switchingThe pain sector is ideal for OTC switching and is a means of mitigating the effects of generic competition. A good example is Novartis' former blockbuster, Voltaren (diclofenac), which was re-launched as an OTC product in 1999 and is now the company's leading OTC brand. The prescription product still maintains relatively strong sales, however, due to long-term trust in the brand in markets in Latin America, the Middle East, Africa and Asia. In 2010, sales of Voltaren (excluding OTC) amounted to US$791 million.

Tackling Opioid Abuse

Opioid abuse is a widely known problem, particularly in the US. Prescription drug abuse in the US is the country's fastest growing drug abuse problem and has been directly correlated to a dramatic increase in the number of prescriptions filled for opioids. According to the Office of National Drug Control Policy, between 1997 and 2007, the milligram-per-person use of prescription opioids in the US increased from 74mg to 369mg while the number of prescriptions for opioids dispensed by retail pharmacies rose from 174 million in 2000 to 257 million in 2009. In 2007, the number of deaths from unintentional overdose of opioids in the US was 11,499, compared with just 2,901 in 1999. Despite the potential for abuse, however, opioids remain important in the treatment of moderate to severe chronic pain and several companies such as Acura and Collegium are developing formulations aimed at deterring abuse.

"...Who are the players, and what are the products, that will shape this US$46 billion sector over the next 5 years...?"

Questions answered

To what extent will generic competition affect Lilly's leading pain drug Cymbalta from 2013 onwards? What legal challenges must Pfizer overcome if Lyrica is to achieve its forecast sales of US$4.2 billion in 2017? What clinical benefits does GW Pharmaceuticals' Sativex offer in the MS market and does the product have new indication opportunities? Grünenthal's Palexia/Nucynta (also marketed by Johnson & Johnson in the US) is widely tipped for rapid growth due to its dual action and better tolerability profile over its opioid competitors. But will these benefits be enough to challenge the lower price of generically available competitors in the future? How did Pfizer improve its market share in 2011 in the pain sector? What techniques are being employed to overcome opioid abuse? Who is developing products that target cancer-related pain? What do the market leaders have in their Phase I/II pipelines?

Contents

CURRENT MARKET 4

Leading Pain Therapies 5

Opioid Analgesics 6

FDA Risk Evaluation and Mitigation Strategy for Opioids 7

Leading Companies 8

Endo Pharmaceuticals 8

Eli Lilly 8

Grünenthal 8

Johnson & Johnson 9

Pfizer 9

Purdue Pharma/Mundipharma/Napp Pharmaceuticals 9

TYPES OF PAIN 9

Acute and Chronic Pain 9

Nociceptive and Neuropathic Pain 10

Psychogenic Pain 10

CURRENT GUIDANCE AND TREATMENT OPTIONS 11

Cancer Pain 11

The World Health Organization's Pain Ladder 11

Cancer Pain Complexity and a Case for Change 11

Neuropathic Pain 12

FUTURE MARKET 14

What's in the Pipeline? 14

Opioid Abuse Deterrents 17

Acura Pharmaceuticals' Aversion Technology 18

Collegium Pharmaceutical's DETERx Technology 18

Durect's Oradur Technology 19

Grünenthal's Tamper Resistant Formulation 19

COMPETITOR RATIO ANALYSIS 20

PRODUCT ANALYSIS 22

NEUROPATHIC PAIN 22

Cymbalta (duloxetine) 22

Mode of Action 22

Approvals 22

Lifecycle Development 23

Proof of Concept/Clinical Data 23

Diabetic Peripheral Neuropathic Pain 23

Chronic Low Back Pain 24

Fibromyalgia 24

Development Risks 24

Company Expertise 24

Competition within the Marketplace 24

Patents 25

Generic Company Activity 25

Competitor Ratio Analysis 26

Sales Forecast 26

Lyrica (pregabalin) 28

Mode of Action 28

Approvals 28

Lifecycle Development 28

Proof of Concept/Clinical Data 29

Central neuropathic pain following spinal cord injury 29

Postherpetic neuralgia and neuropathic pain associated with diabetic peripheral neuropathy 29

Fibromyalgia 29

Development Risks 29

Company Expertise 30

Competition within the Marketplace 30

Patents 30

Generic Company Activity 30

Competitor Ratio Analysis 31

Sales Forecast 31

Lidoderm/Versatis (lidocaine) 33

Mode of Action 33

Approvals 33

Lifecycle Development 33

Proof of Concept/Clinical Data 33

Development Risks 34

Company Expertise 34

Competition within the Marketplace 34

Patents 34

Generic Company Activity 35

Watson Pharmaceuticals 35

Mylan 35

Endo's Citizen Petition Regarding Bioequivalence 36

Competitor Ratio Analysis 36

Sales Forecast 36

Qutenza/NGX-1998 (capsaicin) 38

Mode of Action 38

Approvals 38

Lifecycle Development 38

Qutenza 38

NGX-1998 38

Proof of Concept/Clinical Data 39

Development Risks 39

Company Expertise 39

Competition within the Marketplace 40

Patents 40

Competitor Ratio Analysis 40

Sativex (nabiximols) 41

Mode of Action 41

Approvals 41

Development 41

Proof of Concept/Clinical Data 41

Development Risks 42

Company Expertise 42

Competition within the Marketplace 43

Competitor Ratio Analysis 43

IN DEVELOPMENT FOR NEUROPATHIC PAIN 44

Horizant (gabapentin enacarbil) 44

Mode of Action 44

Approvals 44

Lifecycle Development 44

Proof of Concept/Clinical Data 44

Development Risks 45

Company Expertise 45

Competition within the Marketplace 45

Patents 45

Competitor Ratio Analysis 46

Nuedexta (dextromethorphan+quinidine) 47

Mode of Action 47

Approvals 47

Lifecycle Development 47

Proof of Concept/Clinical Data 47

Development Risks 48

Company Expertise 48

Competition within the Marketplace 48

Patents 48

Generic Company Activity 49

Competitor Ratio Analysis 49

Zebinix (eslicarbazepine acetate) 50

Mode of Action 50

Approvals 50

Lifecycle Development 50

Proof of Concept/Clinical Data 50

Development Risks 50

Company Expertise 51

Competition within the Marketplace 51

Competitor Ratio Analysis 51

AGN-214868 52

Mode of Action 52

Current Status 52

Proof of Concept/Clinical Data 52

Development Risks 52

Company Expertise 52

Competition within the Marketplace 53

Competitor Ratio Analysis 53

ARA290 54

Mode of Action 54

Current Status 54

Proof of Concept/Clinical Data 54

Development Risks 54

Company Expertise 54

Competition within the Marketplace 54

Competitor Ratio Analysis 55

AZD2066 56

Mode of Action 56

Current Status 56

Proof of Concept/Clinical Data 56

Development Risks 56

Company Expertise 56

Competition within the Marketplace 56

Competitor Ratio Analysis 57

AZD2423 58

Mode of Action 58

Current Status 58

Proof of Concept/Clinical Data 58

Development Risks 58

Company Expertise 58

Competition within the Marketplace 59

Competitor Ratio Analysis 59

E2007 (perampanel) 60

Mode of Action 60

Current Status 60

Proof of Concept/Clinical Data 60

Development Risks 60

Company Expertise 61

Competition within the Marketplace 61

Competitor Ratio Analysis 61

EMA401 62

Mode of Action 62

Current Status 62

Proof of Concept/Clinical Data 62

Development Risks 62

Company Expertise 62

Competition within the Marketplace 62

Competitor Ratio Analysis 63

KRN5500 64

Mode of Action 64

Current Status 64

Proof of Concept/Clinical Data 64

Development Risks 64

Company Expertise 64

Competition within the Marketplace 65

Competitor Ratio Analysis 65

NT-11624 (dimiracetam) 66

Mode of Action 66

Current Status 66

Proof of Concept/Clinical Data 66

Development Risks 66

Company Expertise 67

Competition within the Marketplace 67

Competitor Ratio Analysis 67

CNV1014802 68

Mode of Action 68

Current Status 68

Proof of Concept/Clinical Data 68

Development Risks 68

Company Expertise 68

Competition within the Marketplace 68

Competitor Ratio Analysis 69

NOCICEPTIVE PAIN 70

Celebrex (celecoxib) 70

Mode of Action 70

Approvals 70

Lifecycle Development 71

Proof of Concept/Clinical Data 71

Gastrointestinal Events 71

Development Risks 71

Cardiovascular and Gastrointestinal Risks 71

Company Expertise 72

Competition within the Marketplace 72

Patents 72

Generic Company Activity 73

Competitor Ratio Analysis 73

Sales Forecast 73

Duragesic (fentanyl) 75

Mode of Action 75

Approvals 75

Proof of Concept/Clinical Data 75

Development Risks 75

Company Expertise 76

Competition within the Marketplace 76

Competitor Ratio Analysis 76

Sales Forecast 76

OxyContin (oxycodone) 78

Mode of Action 78

Approvals 78

Proof of Concept/Clinical Data 78

Development Risks 78

Company Expertise 79

Competition within the Marketplace 79

Patents 79

Generic Company Activity 79

Competitor Ratio Analysis 80

Sales Forecast 80

Oxecta (oxycodone) 82

Mode of Action 82

Approvals 82

Lifecycle Development 82

Proof of Concept/Clinical Data 82

Development Risks 82

Company Expertise 83

Competition within the Marketplace 83

Patents 83

Competitor Ratio Analysis 84

Opana/Opana ER (oxymorphone) 85

Mode of Action 85

Approvals 85

Lifecycle Development 85

Proof of Concept/Clinical Data 86

Development Risks 86

Company Expertise 86

Competition within the Marketplace 86

Patents 86

Generic Company Activity 87

Competitor Ratio Analysis 88

Sales Forecast 88

Palexia/Nucynta (tapentadol) 90

Mode of Action 90

Approvals 90

Lifecycle Development 90

Proof of Concept/Clinical Data 91

Development Risks 91

Company Expertise 91

Competition within the Marketplace 92

Patents 92

Competitor Ratio Analysis 92

Sales Forecast 93

Vimovo (naproxen+esomeprazole) 94

Mode of Action 94

Approvals 94

Proof of Concept/Clinical Data 94

Development Risks 95

Company Expertise 95

Competition within the Marketplace 95

Patents 95

Generic Company Activity 96

Competitor Ratio Analysis 97

Sales Forecast 97

BuTrans/Norspan (buprenorphine) 99

Mode of Action 99

Approvals 99

Lifecycle Development 99

Proof of Concept/Clinical Data 99

Development Risks 100

Company Expertise 100

Competition within the Marketplace 101

Patents 101

Competitor Ratio Analysis 101

IN DEVELOPMENT FOR NOCICEPTIVE PAIN 102

Remoxy (oxycodone) 102

Mode of Action 102

Current Status 102

Proof of Concept/Clinical Data 102

Development Risks 103

Company Expertise 103

Competition within the Marketplace 103

Competitor Ratio Analysis 104

MoxDuo IR (morphine+oxycodone) 105

Mode of Action 105

Current Status 105

Proof of Concept/Clinical Data 105

Development Risks 105

Company Expertise 105

Competition within the Marketplace 106

Competitor Ratio Analysis 106

ALO-02 (oxycodone+naltrexone) 107

Mode of Action 107

Current Status 107

Proof of Concept/Clinical Data 107

Development Risks 108

Company Expertise 108

Competition within the Marketplace 108

Competitor Ratio Analysis 108

COL-003 (oxycodone) 109

Mode of Action 109

Current Status 109

Proof of Concept/Clinical Data 109

Development Risks 109

Company Expertise 110

Competition within the Marketplace 110

Competitor Ratio Analysis 110

Eladur (bupivacaine) 111

Mode of Action 111

Current Status 111

Proof of Concept/Clinical Data 111

Development Risks 111

Company Expertise 111

Competition within the Marketplace 112

Competitor Ratio Analysis 112

Zohydro (hydrocodone bitartrate) 113

Mode of Action 113

Current Status 113

Proof of Concept/Clinical Data 113

Development Risks 113

Company Expertise 114

Competition within the Marketplace 114

Competitor Ratio Analysis 114

NP2 Enkephalin 115

Mode of Action 115

Current Status 115

Proof of Concept/Clinical Data 115

Development Risks 115

Company Expertise 115

Competition within the Marketplace 116

Competitor Ratio Analysis 116

Tanezumab 117

Mode of Action 117

Current Status 117

Proof of Concept/Clinical Data 117

Development Risks 118

Company Expertise 118

Competition within the Marketplace 118

Competitor Ratio Analysis 118

ARRY-797 119

Mode of Action 119

Current Status 119

Proof of Concept/Clinical Data 119

Development Risks 119

Company Expertise 119

Competition within the Marketplace 119

Competitor Ratio Analysis 120

SOURCES 121

Espicom Sources 121

Others 121

INDEX 122

List of Tables

Drugs Approved for Neuropathic Pain in the US and EU 13

Drugs in Development for Pain 14

Competitor Ratio Analysis Summary 21

Cymbalta US Patents 25

FDA Tentative ANDA Approvals for Duloxetine 26

Cymbalta Sales, 2010-2017 (US$ Million) 26

Lyrica US Patents 30

FDA Tentative ANDA Approvals for Pregabalin 31

Lyrica Sales, 2010-2017 (US$ Million) 31

Lidoderm US Patents 35

Lidoderm/Versatis Sales by Company, 2010-2017 (EUR & US$ Million) 37

Qutenza US Patents 40

Horizant US Patents 45

Nuedexta US Patents 49

Celebrex US Patents 72

Celebrex/Celecox Sales by Company, 2010-2017 (¥ & US$ Million) 74

Duragesic Sales, 2010-2017 (US$ Million) 76

OxyContin US Patents 79

OxyContin Sales, 2010-2017 (US$ Million) 80

Oxecta US Patents 83

Opana ER US Patents 87

FDA ANDA Approvals for Oxymorphone ER 87

Opana/Opana ER Sales, 2010-2017 (US$ Million) 88

Nucynta US Patents 92

Palexia/Nucynta Sales, 2010-2017 (US$ Million) 93

Vimovo US Patents 96

Vimovo Sales, 2011-2017 (US$ Million) 97

BuTrans US Patents 101

List of Figures

NHS Opioid Analgesic Prescriptions by Volume, 2010 (%) 6

NHS Opioid Analgesic Prescriptions by Cost, 2010 (%) 7

Leading Companies in Pain Management by Revenue (%) 8

Cymbalta Sales Trend, 2007-2017 27

Lyrica Sales Trend, 2007-2017 32

Lidoderm/Versatis Sales Trend, 2008-2017 37

Celebrex/Celecox Sales Trend, 2007-2017 74

Duragesic Sales Trend, 2007-2017 77

OxyContin Sales Estimate, 2010-2017 81

Opana/Opana ER Sales Trend, 2007-2017 89

Palexia/Nucynta Sales Trend, 2009-2017 93

Vimovo Sales, 2011-2017 98

To order this report:Drug and Medication Industry: Evolution in the Pain Therapy Drugs Market: Nociceptive and Neuropathic Drug Development

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