US Cancer Pain Report

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1 Brochure More information from US Cancer Pain Report Description: The US market for the drug treatment of cancer pain in 2008 is valued at $3.1 billion, according to US Cancer Pain Report The cancer pain market is dominated by opioid drugs, a trend expected to continue throughout the next decade. The increasing number of cancer pain patients will be the primary driver of market value during the forecast period. Few of the many drugs in development for pain conditions are seeking regulatory approval for cancer pain. Of these, most are reformulations of fentanyl or other opioids, using novel delivery devices or as combination therapies. Reformulations of existing opioids are unlikely to capture market share unless they can compete economically with older agents that are already available on payer-approved formularies. Today, half of the 4.1 million cancer patients in the US experience pain. More than 600,000, among these, experience moderate-to-severe pain. Estimates that the cancer pain market will be valued at $5.3 billion in 2018, based on a patient population of more than 2.5 million cancer pain patients. While most pain is the result of tissue damage caused by the tumor, some cancer pain is due to the effects of chemotherapy, radiation or surgery; moreover, 25% of patients experience more than one type of cancer pain. Estimates for 2008 and projections to 2018 for SEVEN types of cancer pain: tumor-related, treatmentrelated, neuropathic, breakthrough pain, malignant bone pain, visceral pain and soft-tissue pain. Interviews with oncologists and pain clinicians, as well as data from US Pain Clinic Monitor provide additional perspective on the cancer pain market. US Pain Clinic Monitor is an audit of more than 100 pain clinics that includes prescribing data on cancer pain and 26 other pain indications. Worldwide, only 25 agents are in active clinical trials for the treatment of cancer pain, but more than 150 agents could have the potential to treat cancer pain. All of these agents are reviewed in this report. Currently, worldwide, 42 drugs with the potential to treat cancer pain have reached Phase III+ in their clinical development. The 15 Phase III+ compounds that are being studied specifically for the treatment of cancer pain include novel delivery approaches for the opioid receptor agonist fentanyl (nine compounds), novel formulations of morphine (two compounds), an NMDA receptor antagonist (intranasal ketamine), a topical combination of ketamine and amitriptyline (NP-1, for chemotherapy-induced neuropathy), an IM sodium channel antagonist (tetrodotoxin), and an oral serotonin receptor agonist that stimulates nerve growth factor release (xaliproden). Most of the drugs recently approved in the world for the treatment of cancer pain are opiates. One exception is GW s dronabinol/cannabidiol (Sativex), a cannabinoid receptor agonist recently approved in Canada for the treatment of cancer pain. The US has not seen a recent approval, but BDSI s ONSOLIS has reached a pre-registration stage of development in the US. Market Value 2008 and the Future: The US cancer pain market is currently valued at $3.1 billion (2008). Opioids dominate the market ($2.0 billion), followed by medications commonly used to treat inflammatory pain, such as corticosteroids, anesthetics, and NSAIDs (combined, $1.0 billion). Anticonvulsants and antidepressants make up a comparatively small portion of the cancer pain market ($53 million) since they are for treating only those patients with neuropathic pain. During the forecast period the anticonvulsant segment will grow at the same rate as the entire cancer pain market. Growth is this segment will be driven by the continued uptake of Lyrica, which will be patent-protected throughout the forecast period, but tempered by generic gabapentin s ongoing erosion of Neurontin s sales. Growth of the opioid segment during the forecast period will outpace growth of the overall cancer pain market, primarily fueled by new formulations of existing products like the recently-approved, short-acting drug tapentadol. The US cancer pain market is projected to reach $5.3 billion in 2018, representing a compound annual growth rate of 5.5% ( ). Types of Cancer Pain and Prevalence: Approximately 4.1 million people living in the U.S. in 2008 have had a cancer diagnosis in the previous 5 years. Half of these patients, about 2 million people, experience pain. Just over 600,000 cancer patients experience moderate to severe pain from one or more of the following types of cancer pain: - Tumor-related pain;

2 - Treatment-related pain; - Soft-tissue pain; - Visceral pain; - Neuropathic pain; - Bone pain; and - Breakthrough pain. Tumor growth and invasion can cause different types of pain depending upon the type of tissue being destroyed by the tumor: - Inflammatory or nociceptive pain is caused by invasion and destruction of somatic tissues such as skin and muscles with concomitant inflammatory reactions, and is detected by somatic sensory nerves. The pain is generally felt in the location of the tissue damage. - Visceral pain is caused by tumor invasion of internal organs and their surrounding tissues, and is detected by autonomic nerve fibers. The pain is often felt at sites distant to the site of tumor invasion, making it difficult to pinpoint the source the pain. - Neuropathic pain is caused by tumor damage directly to the nerves, and can be persistent and debilitating. The pain is often described as electrical or lancinating. - Bone pain is caused by tumor invasion of bones, which can promote either destruction or excessive growth of nerve fibers within the bone tissue. Additionally, cancer treatments can cause acute or chronic pain: - Surgeries to remove tumors can cause residual scar tissue and damage to internal organs or nerves that provokes pain. - Certain chemotherapies damage nerves and cause treatment-induced neuropathic pain. Finally, most cancer patients in pain experience sudden periods of intensified pain called breakthrough pain, because the pain breaks through the baseline level of analgesia provided by whatever pain medications the patient is taking. Diagnosis and Assessment: The assessment of the cancer patient in pain is largely subjective, as it is difficult to empirically quantify pain. Oncologists and pain specialists may use a variety of pain scales to quantify and characterize the patient s pain; some of these may be helpful in identifying the etiology of the pain as well. Functional scales are gaining in popularity because they quantify the effect of the pain on the ability of patients to perform daily functions. Standard history taking and physical exam techniques also provide important information on the source and intensity of a patient s pain. All of these techniques can also be used to measure treatment success. However, these approaches are inconsistent from patient to patient, and even over time in individual patients; thus, physicians must rely on a heavy dose of clinical judgment to assess patients and develop effective treatment plans. Treatment: Opioids are the treatment of choice for cancer patients in moderate to severe pain. They provide powerful analgesia but come with a number of potentially dose-limiting side effects that often need to be managed with additional adjuvant medications. Additionally, patients often develop tolerance to the analgesic effects over time, requiring dose increases or the trial of new drugs. While high-dose opioids may be efficacious in the treatment of neuropathic pain, newer antidepressant and anticonvulsant drugs are preferred. Interventional approaches such as nerve blocks and intrathecal pumps are used in appropriate situations. Alternative therapies are frequently offered by oncology centers. The design of any efficacious treatment regimen may require a trial-and-error approach, in which different combinations of drugs will be custom-titrated to provide the best balance between analgesia and side effects. Most cancer patients in moderate to severe pain are treated at oncology clinics, which may have insufficient experience or resources to aggressively manage pain. Specialized pain clinics are becoming more common in the US, but the oncologists utilization of resources in this setting remains low. Unmet needs: Oncologists and pain specialists surveyed have cited two main unmet needs in the treatment of cancer pain: Access to treatments: 1. The availability of low-priced generics, such as opioids and gabapentin, makes it difficult to obtain payer approval to prescribe expensive, newer medications, even when these drugs provide a therapeutic advantage. 2. Oncologists are reluctant to utilize pain specialists to manage pain in cancer patients, even though pain

3 clinics are becoming more common and can provide expertise. Novel therapies: 1. Improved efficacy in the treatment of neuropathic, visceral and bone pain is desired by clinicians. 2. Novel mechanisms of action must be developed in order to better address specific pain subtypes and breakthrough pain. 3. Drugs that can provide opioid-like analgesia with fewer side effects and less tolerance are still needed. 4. Longer-acting opioids could still be of clinical benefit. Physicians already have sufficient options that provide fast onset of relief. Future treatments: Few drugs, among the many in development for pain conditions, are specifically seeking regulatory approval for use in cancer pain. Of these, most are reformulations of fentanyl or other opioids, using novel delivery devices or as combination therapies. These products are unlikely to capture market share unless they can compete economically with older agents already available on payer-approved formularies. Cannabinoid drugs and tapentadol have the greatest potential for success among the novel agents that may enter the market soon. Cannabinoids represent a novel mechanism of action to add to the limited spectrum that is currently available. Tapentadol is noteworthy because it simultaneously targets two different pain pathways. Anticonvulsants and antidepressants in development for the treatment of neuropathic pain will be of benefit to a portion of the cancer pain population. However, their use will be restricted by reimbursement hurdles. Contents: TABLE OF CONTENTS LIST OF FIGURES LIST OF TABLES I. EXECUTIVE SUMMARY II. INTRODUCTION AND METHODOLOGY III. PHYSIOLOGY OF CANCER PAIN A. Definition of Cancer Pain 1. Nociceptive Cancer Pain 1.1 Nociceptive Cancer Pain Mechanisms 2. Neuropathic Cancer Pain 2.1 Characteristics of Neuropathic Pain 2.2 Cellular Mechanisms of Neuropathic Pain 2.3 Chemotherapy-Induced Neuropathy 2.4 Other Sources of Neuropathic Cancer Pain 3. Breakthrough Cancer Pain 3.1 Breakthrough Cancer Pain Mechanisms 4. Malignant Bone Pain 4.1 Malignant Bone Pain Mechanisms 5. Visceral Cancer Pain 5.1 Visceral Cancer Pain Mechanisms IV. CLINICAL ASSESSMENT OF CANCER PAIN 1. Qualitative Description of Pain

4 2. Standard Quantitative Pain Measurement Scales 2.1 McGill Pain Questionnaire (MPQ) 2.2 M.D. Anderson Symptom Inventory (MDASI) 2.3 Brief Pain Inventory (BPI) 2.4 Visual Analog Scale (VAS) 2.5 The Neuropathic Pain Scale (NPS) 2.6 Pain Assessment by Functional Scales 3. Physical Examination of the Cancer Pain Patient 3.1 Characterizing Underlying Systemic Illness 3.2 Regional Pain Physical Examination V. EPIDEMIOLOGY CURRENT AND FUTURE 1. Cancer Pain 1.1 Incidence of Cancer Pain 1.2 Prevalence of Cancer Pain 2. Incidence and Prevalence of Cancer Pain by Pain Type 2.1 Tumor-Related Cancer Pain 2.2 Treatment-Related Cancer Pain 2.3 Neuropathic Cancer Pain 2.4 Breakthrough Cancer Pain 2.5 Malignant Bone Pain 2.6 Visceral Cancer Pain 2.7 Soft-Tissue Cancer Pain 3. Basis for Target Population 4. US Cancer Pain Population Forecasts VI. APPROACHES TO TREATMENT OF CANCER PAIN A. Actual Clinical Practice 1. Opioids and Semi-Synthetic Narcotics 1.1 Categorization of Opioids 1.2 Opioid Treatment Design 1.3 Management of Opioid Side Effects 1.4 Specific Opioids Used in the Treatment of Cancer Pain 2. Anti-Inflammatory Pain Medications 3. Corticosteroids 4. Anesthetics 5. Anticonvulsants 6. Antidepressants 7. Other Drugs 8. Surgery and Radiation 9. Alternative Therapies B. Clinical Practice Guidelines

5 1. World Health Organization Guidelines 2. National Comprehensive Cancer Network Guidelines C. Limitations of Current Treatment 1. Limitations in Patient Access to Treatments 2. Limitations in Current Products Performance D. Promising New Approaches E. Future Trends VII. DRUGS IN CLINICAL DEVELOPMENT TO TREAT CANCER PAIN 1. Overview 2. Recent Approvals and Launches 3. Current Pipeline 3.1 Phase III, Pre-registration, and Registration 3.2 Phase II 3.3 Phase I 4. New Formulations and Combinations of Already Approved Pain Drugs VIII. MARKET FORECASTS AND ESTIMATES CURRENT AND FUTURE A. Current Sales of Pharmaceutical Products, By Drug Class US Market: Summary by Drug Class 1.1 Opioids 1.2 Corticosteroids/Other 1.3 Anesthetics 1.4 Anti-Inflammatories 1.5 Anticonvulsants 1.6 Muscle Relaxants 1.7 Antidepressants 1.8 Methodology B. Market Forecast for Cancer Pain, US Market: Forecast by Drug Class 1.1 Opioids 1.2 Corticosteroids/Other 1.3 Anesthetics 1.4 Anti-Inflammatories 1.5 Anticonvulsants 1.6 Muscle Relaxants 1.7 Antidepressants Ordering: Order Online - Order by Fax - using the form below Order by Post - print the order form below and send to

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