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治療クラスの概要:中度から重度の疼痛:疼痛管理における新規の乱用抑止製剤技術と新しいメカニズムの台頭

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

発行 MP Advisors 商品コード 322979
出版日 ページ情報 英文
納期: 即日から翌営業日
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治療クラスの概要:中度から重度の疼痛:疼痛管理における新規の乱用抑止製剤技術と新しいメカニズムの台頭 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: 2015年01月01日 ページ情報: 英文
概要

当レポートでは、疼痛管理における新規の乱用抑止製剤技術と新しいメカニズムの台頭について調査分析し、概要、利点と欠点、ガイドライン、プラットフォーム、パイプライン分析などについて、体系的な情報を提供しています。

第1章 疼痛の管理

  • イントロダクション
  • 疼痛の分類(種類と強さ)
  • 慢性疼痛の治療:現在のアプローチ
  • 疼痛の市場規模と現在の治療オプション(急性、慢性、神経因性疼痛)
  • 医学的アンメットニーズと市場機会
  • 中度から重度の疼痛と神経因性疼痛に対する上市薬の概要
  • 非オピオイド薬の利点と欠点
  • 非麻薬性治療の必要性:薬物乱用と耐性

第2章 規制薬物に対するFDAスケジュールとスケジュールII・IIIの利点

第3章 乱用抑止製剤の開発に対するFDAガイドライン

第4章 上市薬・パイプラインにおける乱用抑止技術プラットフォーム

  • 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 疼痛治療における新しいメカニズムのパイプライン分析

  • 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 神経因性疼痛における後期パイプライン開発

  • 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 乱用抑止製剤(オピオイド)企業に対するFDAの見通し

  • 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

図表

目次
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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