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市場調查報告書

治療層級概要:從中度到重度的疼痛:疼痛管理上新的濫用抑制製劑技術與新機制的崛起

Therapeutic Class Overview : Moderate to Severe Pain: Novel Abuse Deterrent Formulation Technologies and Emergence of Novel Mechanisms in the Management of Pain

出版商 MP Advisors 商品編碼 322979
出版日期 內容資訊 英文
商品交期: 最快1-2個工作天內
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治療層級概要:從中度到重度的疼痛:疼痛管理上新的濫用抑制製劑技術與新機制的崛起 Therapeutic Class Overview : Moderate to Severe Pain: Novel Abuse Deterrent Formulation Technologies and Emergence of Novel Mechanisms in the Management of Pain
出版日期: 2015年01月01日 內容資訊: 英文
簡介

本報告提供疼痛管理上新的濫用抑制製劑技術與新機制的崛起調查分析、概要、優點和缺點、指南、平台、開發平台分析等相關的系統性資訊。

第1章 疼痛的管理

  • 簡介
  • 疼痛的分類(種類與強度)
  • 慢性疼痛的治療:目前方法
  • 疼痛的市場規模與目前治療選擇(急性、慢性、神經性疼痛)
  • 醫學性未滿足需求與市場機會
  • 從中度到重度的疼痛和神經性疼痛的上市藥概要
  • 非Opioids(類鴉片物質)藥的優點和缺點
  • 非麻醉劑治療的必要性:藥物濫用和抗性

第2章 FDA計劃和計劃II、III對法規藥物的優點

第3章 對濫用抑制製劑的開發的FDA指南

第4章 上市藥、開發平台的濫用抑制技術平台

  • a. AVERSION
  • b. IMPEDE
  • c. DETERx
  • d. PODRAS
  • e. IntelliPaste
  • f. nPODDDS
  • g. INTAC
  • h. ORADUR
  • i. Implantable pump for intrathecal delivery
  • j. OPTIGEL Lock
  • k. Small molecule delivery
  • l. Bio-MD-prodrugs platform
  • m. Ligand activated Therapy (LAT)
  • n. NOBUSE
  • o. ORADUR
  • p. EGALET
  • q. Inspirion delivery Technologies
  • r. Intellitab Technology
  • s. Trigger lock platforin - Micropump
  • t. Fenrock
  • u. Smart Patch PNS system

第5章 疼痛治療中的新機制的開發平台分析

  • a. Multi-day formulation of Tramadol
  • b. Bio-MD Platform
  • c. Angiotension II antagonist
  • d. Anti-NGF
  • e. Ligand Activate Therapy
  • f. Nav 1. 7 inhibitor
  • g. GPCR - Dimer Screen Technology
  • h. CB agonist
  • i. Peptide Therapeutics (conopeptide)
  • j. TRPV1 antagonist
  • k. Fentanyl based therapy formulation modification (micro and nano tab)
  • l. Oromtrcosal delivery
  • m. Opioid alternaties (dexinedetomidine)
  • n. Steroidal intraacticular injection
  • o. TrkA receptor antagonist

第6章 神經性疼痛的後期開發平台開發

  • a. Cebranopadol
  • b. Mirogabalin
  • c. CNV-2197944
  • d. Sativex
  • e. Once daily pregabalin
  • f. Topicalclonidinegel
  • g. Topical ketanrine and amitraline
  • h. Eladur
  • i. GRC-17536
  • j. DWPO5195

第7章 FDA對濫用抑制製劑(Opioids(類鴉片物質))企業的預測

  • AbbVie
  • AcelRx
  • Acorda Therapeutics
  • Actavis
  • Acura Pharma
  • Altus formulations
  • Amorsa Therapeutics
  • AstraZeneca
  • BioDelivery Sciences Intenational Inc.
  • Cara Therapeutics
  • Catalent
  • Charleston
  • Collegium Pharma
  • Convergence
  • Daiichi
  • Daewoong
  • Depoined
  • Durect
  • Egalet
  • Eli Lilly
  • Elite Pharma
  • Endo
  • Flamel Technologies
  • Flexion Therapeutics
  • Glenmark
  • Immune Pharmaceuticals
  • Impax Pharmaceuticals
  • Inspirion Delivery technologies
  • Intelli Pharmaceutics
  • KemPharm
  • Kineta
  • Kunwha Pharmaceutical
  • Medallion Teherapeutics
  • Nektar
  • Orbis Biosciences
  • Orbxo
  • Pain Therapeutics
  • Pfizer
  • Purdue
  • Recro
  • Relmada Therapeutics
  • Signature Therapeutics
  • Spinifex pharma
  • SPR Therapeutics
  • Teikoku
  • Teva
  • Trevena Inc.
  • Tris Pharma
  • Valeant
  • Xenon Pharma
  • XenoPort

圖表

目錄
Product Code: TC15011301

Cover Image Pain is the leading cause of disability in the US, affecting more than cancer, diabetes and heart disease combined. Current analgesics for persistent pain are relatively ineffective, are associated with significant adverse effects or abuse liability, and do not reduce pain in all treated individuals. Opioids (e.g., morphine, codeine, oxycodone) are currently one of the most potent groups of analgesics used clinically, with prescriptions increasing by 50% over the past 10 years for chronic, non-cancer pain. However, there is clear evidence that as opioid prescription rate rise, there is a corresponding increase in opioid overdose deaths, misuse and addiction. These adverse effects are attributed to the opioid agonist effects on central opioid receptors-causing dependence, tolerance, sedation, and respiratory depression.

Non-steroidal and steroidal anti-inflammatory drugs have serious side effects such as gastric erosions, ulcer formation, bleeding, hypersensitivity reactions, cardiovascular toxicity, renal toxicity, and hepatotoxicity. In addition, they are also not peripherally selective thereby causing a range of central adverse effects. Over the past 20 years, most analgesic development activities have been limited to the reformulation of opioids, production of new cyclooxygenase (COX) inhibitors, amine reuptake inhibitors and anticonvulsants, and introduction of topical local anesthetics-all of these act on well-established targets. A significant unmet need exists in the emergence of novel mechanism which will avoid the current NSAIDS side effects with improved efficacy. Several newer mechanisms currently being explored will have the ability to replace opioids in the treatment of acute and chronic moderate to severe pain.

Globally, pain is one of the important therapy areas with a market size of over $50b in 2013, and is expected to grow at 10%. The recent patent expiry of Cymbalta and Lyrica (2018) will have significant impact on the overall pain market size in the near future. However, several pipeline molecules are emerging to fill this gap. The importance of abuse deterrent labeling in the formulations can be better understood from FDA's non-approval of oxycontin generics in 2013. The revised labeling with abuse deterrence has protected Purdue's oxycontin revenue slide from its generization.

In the wake of abusive potential of opioids drugs reported all across the US, FDA recently drafted guidance for evaluation and labeling of opioids formulations based on their ability to reduce its abusive potential (tier 1 to 4). Despite the process being in nascent stage, several specialty companies have already ventured into the development of abuse deterrent formulations to reap benefits in the near future.

In this report, we have discussed a number of novel delivery technologies employed in the formulation of abuse deterrent product, technologies employed in enhancing patient compliances and emerging novel mechanisms in the management of pain. Renewed interest on pain therapy is vision as recently Biogen Idec acquired Convergence's CNV1014802 (Nav 1.7 sodium channel blocker) to expand its neuropathic pain portfolio and we believe several such acquisitions will happen in the near term.

Table of Contents

1. Management of Pain

  • Introduction
  • Classification of Pain (Type and Intensity)
  • Treatment of chronic pain - current approach
  • Market Size of pain and current therepeutic options (acute, chronic pain and neuropathic pain)
  • Unmet medical need and market opportunities
  • Overview of Marketed drugs for moderate to severe pain and neuropathic pain
  • Advantages and Limitations of non-opioid drugs
  • Necessity for non-opiate treatment Drug abuse and tolerance

2. FDA Schedule for controlled substances and advantage of Schedule III over II

3. FDA Guidelines for the development of abuse deterrent formulations

4. Abuse deterrent Technology Platforms employed in marketed drugs and pipeline

  • a. AVERSION
  • b. IMPEDE
  • c. DETERx
  • d. PODRAS
  • e. IntelliPaste
  • f. nPODDDS
  • g. INTAC
  • h. ORADUR
  • i. Implantable pump for intrathecal delivery
  • j. OPTIGEL Lock
  • k. Small molecule delivery
  • l. Bio-MD-prodrugs platform
  • m. Ligand activated Therapy (LAT)
  • n. NOBUSE
  • o. ORADUR
  • p. EGALET
  • q. Inspirion delivery Technologies
  • r. Intellitab Technology
  • s. Trigger lock platforin - Micropump
  • t. Fenrock
  • u. Smart Patch PNS system

5. Pipeline analysis of Novel Mechasim in Pain Therapy

  • a. Multi-day formulation of Tramadol
  • b. Bio-MD Platform
  • c. Angiotension II antagonist
  • d. Anti-NGF
  • e. Ligand Activate Therapy
  • f. Nav 1. 7 inhibitor
  • g. GPCR - Dimer Screen Technology
  • h. CB agonist
  • i. Peptide Therapeutics (conopeptide)
  • j. TRPV1 antagonist
  • k. Fentanyl based therapy formulation modification (micro and nano tab)
  • l. Oromtrcosal delivery
  • m. Opioid alternaties (dexinedetomidine)
  • n. Steroidal intraacticular injection
  • o. TrkA receptor antagonist

6. Late stage pipeline developments in neuropathic pain

  • a. Cebranopadol
  • b. Mirogabalin
  • c. CNV-2197944
  • d. Sativex
  • e. Once daily pregabalin
  • f. Topicalclonidinegel
  • g. Topical ketanrine and amitraline
  • h. Eladur
  • i. GRC-17536
  • j. DWPO5195

7. FFA Perspective on Abuse deterrent formulations (Opioids) Companies mentioned:

  • AbbVie
  • AcelRx
  • Acorda Therapeutics
  • Actavis
  • Acura Pharma
  • Altus formulations
  • Amorsa Therapeutics
  • AstraZeneca
  • BioDelivery Sciences Intenational Inc.
  • Cara Therapeutics
  • Catalent
  • Charleston
  • Collegium Pharma
  • Convergence
  • Daiichi
  • Daewoong
  • Depoined
  • Durect
  • Egalet
  • Eli Lilly
  • Elite Pharma
  • Endo
  • Flamel Technologies
  • Flexion Therapeutics
  • Glenmark
  • Immune Pharmaceuticals
  • Impax Pharmaceuticals
  • Inspirion Delivery technologies
  • Intelli Pharmaceutics
  • KemPharm
  • Kineta
  • Kunwha Pharmaceutical
  • Medallion Teherapeutics
  • Nektar
  • Orbis Biosciences
  • Orbxo
  • Pain Therapeutics
  • Pfizer
  • Purdue
  • Recro
  • Relmada Therapeutics
  • Signature Therapeutics
  • Spinifex pharma
  • SPR Therapeutics
  • Teikoku
  • Teva
  • Trevena Inc.
  • Tris Pharma
  • Valeant
  • Xenon Pharma
  • XenoPort

Tables:

  • Table-1: US Pain Market Size
  • Table-2: Classification Based on Intensity of Pain
  • Table-3: Marketed Fentanyl Dosage Forms(US): Transdermal Patches, Buccal And Sublingual Tablets And Films For Pain Relief
  • Table-4: Commonly Used Opioids For Pain Management
  • Table-5: Marketed Drugs for Neuropathic Pain
  • Table-6: Drug Enforcement Authority (DEA) Controlled Substances Schedule Criteria
  • Table-7: Summary of Controlled Substances Act requirements
  • Table-8: Common Non-Opioids-Acetaminophen and NSAlDs
  • Table-9: Benefits of Sublingual Microtablets vs. IV morphine Patient Controlled Analgesia

Charts:

  • Chart-1: Classification of Pain
  • Chart-2: Pain Relief Ladder-WHO
  • Chart-3: Neuropathic Pain market size and projection through 2020
  • Chart-4: Global Healthcare Market Expenditure through 20l8: Therapy Class
  • Chart-5: Global NME (2008-12) Availability in 2013
  • Chart-6: Death Rates from Prescription opioids overdose in the US
  • Chart-7: DETERx Multiparticulate system
  • Chart-8: PF614: Prodrug of Oxycodone(ER Oxycodone)
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