Pain Management- New Discoveries And Treatment Options In Abuse Deterrent Era • Opioids - Novel Abuse deterrent Formulation Technologies & Pipeline drugs • Emerging Novel Technologies, Mechanisms and late stage pipeline drugs in the Management of Pain
Table of Contents
1. Executive Summary
a. ER formulation of Opioids- An initial target for pipeline Abuse deterrent drugs & a high priority by Regulators?
b. Late stage pipeline drugs and new MoA – which has potential to reduce Opioid use in moderate pain?
c. New FDA guidelines for Oral solid abuse deterrent generic formulations - A kick start of generic cycle for ADF formulations?
d. Key pipeline ER abuse deterrent drugs, its ROA, tech platform etc
e. Possible implications of rescheduling Hydrocodone from CIII to CII on Opioids market & ADF development.
2. Management of Pain
Classification of Pain (Type and Intensity)
Treatment of chronic pain – current approach
Market Size of pain and current therapeutic options (acute, chronic pain and neuropathic pain)
Unmet medical need and market opportunities in overall Pain management
Overview of Marketed drugs for moderate to severe pain and neuropathic pain
Limitations of non-opioids drugs and overview of marketed drugs
Non-steroidal Anti-inflammatory Drugs (NSAID) – Mechanism of action
Necessity for non-opiate treatment –Drug abuse deterrent and tolerance
Opioid Abuse deterrent Epidemic- A Whistle Blower for FDA to take Stringent Action and start of abuse deterrent Era
ER opioids vs. IR opioids- Abuse deterrent potential
3. FDA Schedule for controlled substances and advantage of Schedule III over II
Hydrocodone rescheduling to Class II –
o Prescription trend post rescheduling
Advantage to other Opiates & advantage to ER ADF opioids to grow due to rescheduling
4. FDA Perspective on Abuse deterrent formulations (Opioids)
FDA perspective on Abuse deterrent Opioids- Observations from early experience with Abuse deterrent formulation development.
FDA view of the Evolution of the Abuse deterrent Opioid market
Tools FDA Intends to use to move the market toward its goal
ADF Labeling – Importance and advantage for reimbursement, REMS need
Our view on FDA guidelines for Abuse deterrent Formulation developments
Our view on FDA guidelines for Generic Abuse deterrent Formulation developments
5. Approved Abuse deterrent Formulations by FDA - Development , label claim, Technology and current prescription trend
Common Manufacturing approach for making ADF formulation
Abuse deterrent drugs approval from FDA in 2014- its Technology platform and current prescription trend in US
Abuse deterrent approval from FDA in 2015- its Technology platform and current prescription trend in US
Recently approved ER Formulation of Patent expired molecules for pain management
6. Abuse Deterrent Technology Platforms employed in marketed drugs and pipeline
k. Implantable pump for intrathecal delivery
l. OPTIGEL Lock
m. Small molecule delivery
n. Bio-MD-prodrugs platform
o. Ligand activated Therapy (LAT)
s. Inspirion delivery Technologies
t. Intellitab Technology
u. Trigger lock platform –Micropump
v. Proprietary / OraGuard Technology
w. Pain Therapeutics
y. Smart Patch PNS system
z. ALO-02/Troxyca ER
aa. BeadTek and INTELLITAB technology
bb. Acuform Technology
cc. OROS Technology
dd. Resistec Technology
ee. SENTRYBOND Technology
7. Pipeline analysis of Novel Technologies and new mechanisms in Pain management
a. Multi-day formulation of Tramadol
b. Bio-MD Platform
c. Orexo- Sublingual technology
d. Fentanyl based therapy formulation modification (micro and nano tab)
e. Acorda Therapeutics
f. Bilayered oral formulation- Charleston lab
h. Steroidal intraarticular injection
i. Intrathecal drug delivery system
j. Oromucosal delivery
New mechanisms in Pain management
a. Angiotension II antagonist
c. Ligand Activate Therapy
d. Nav1. 7 inhibitor
e. GPCR –Dimer Screen Technology
f. CB agonist
g. Kappa Receptor agonists
h. TrkA receptor antagonist
i. MAP kinase inhibitor
j. Opioid alternatives (dexmedetomidine)
k. Peptide Therapeutics (conopeptide)
l. TRPV1 antagonist
m. Gene therapy
8. Late stage pipeline developments in neuropathic pain
a. Cebranopadol (oral, once daily, Grunenthal/ Depomed, PhIII, chronic pain)-A potential threat to abuse deterrent formulations
b. Mirogabalin- Key MOA diff vs. Lyrica, Pros & Cons analysis based on reported PhII data
e. Convergence/ biogen Idec- CNV-2197944
f. Convergence/ biogen Idec- CNV-1014802
h. Once daily pregabalin
i. Topical clonidine gel
j. Topical ketamine and amitraline
k. Amorsa therapeutics
l. Pregabalin CR
q. Algiax Pharmaceuticals
Appendix – I FDA Guidelines for the development of abuse Deterrent Formulations
Types of Abuse deterrent formulation as per current guidance
Pre market studies
Post market studies
Appendix- II General Principles for Evaluating the Abuse deterrent Generic Solid Oral Opioid Drug Products
Need for regulatory filing and other key requirements
Route of Abuse deterrent
Comparative in Vitro Studies
List of Tables
Table-1(A): Key pipeline ER Abuse Deterrent Drugs, its ROA, techplatform
Table-1(B): Key pipeline ER Abuse Deterrent Drugs, its ROA, techplatform
Table-1(C): Key pipeline ER Abuse Deterrent Drugs, its ROA, techplatform
Table-1(D): Key pipeline ER Abuse Deterrent Drugs, its ROA, techplatform
Table-2: Non-Injectable Opioid Pain TRx+share-US
Table-3: Classification Based on Intensity of Pain 2013-2014
Table-4: Marketed Fentanyl Dosage Forms (Us): Transdermal Patches, Buccal And Sublingual Tablets And Films For Pain Relief
Table-5: Commonly Used Opioids for Pain Management
Table-6: Marketed Drugs for Neuropathic Pain
Table-7: Drug Enforcement Authority (DEA) Controlled Substances Schedule Criteria
Table-8: Summary of Controlled Substances Act requirements
Table-9: Overview of pivotal studies conducted in the ALO-02 development program
Table-10: Benefits of Sublingual Microtablets vs. IV morphine Patient Controlled Analgesia
Table-11: Marketed formulation of Oromucosal product
Table-12: Microgabalin –WW ongoing key clinical trials
List of Charts
Chart -1: Classification of Pain
Chart-2: Pain is multi-factorial
Chart-3: Pain Relief ladder-WHO
Chart-4: Neuropathic Pain market size and projection through 2020
Chart-5: Medicine spending in 2020 US$ by geography, product type and disease area
Chart-6: Specialty Medicines and Leading therapy areas in 2020
Chart-7: Number of Death from Prescription drugs
Chart-8: Number of Death from Heroin
Chart-9: Hydrocodone prescription volume has noticeably declined since up-scheduling
Chart-10: Total opioid market TRx and sales growth
Chart-11: Recent long acting opioids TRx launches
Chart-12: NUCYNTA ER prescription trend-us post launch in June 2015
Chart-13: Abuse Deterrent pipeline in development-Acura pharma
Chart-14: DETERx Multiparticulate system
Chart-15: Design element of DETERx as used in Xtampza
Chart-16: Pipeline of Collegium Pharma
Chart-17: Pipeline of Intellipharmaceuticals
Chart-18: Abuse Deterrent Technology platform of Elite Pharmaceuticals
Chart-18(a): Abuse Deterrent Technology platform- One Bead System
Chart-18 (b): Abuse Deterrent Technology platform- Two Bead System
Chart-19: Guardian Technology combines abuse deterrent- features with a precision zero-order profile
Chart-20: Egalet product pipeline using GuardianTM Technology
Chart-21: Egalet’s guardian technology as used in ARYMO and Egalet-002
Chart-22: OraguardTM Manufacturing process used for Vantrela ER
Chart-23: Diagram of the cross-section of an ALO-02 pellet
Chart-24: Zohydro ER’s BeadTek technology-PEO Gels in liquids
Chart-25: Exalgo’s OROS Delivery technology- Deigned for ER not ADF
Chart-26: Stratum Tech platform- Orbis Bioscience
Chart-27: Tramadol in Vitro Pharmacokinetic
Chart-28: PF614: Prodrug of Oxycodone (ER Oxycodone)
Chart-29: Pipeline of Enysce Bioscince
Chart-30: ZilrettaTM cilical phase study for pain
Chart-31: Biodelivery science International BEMA technology
Chart-32: Product in pipeline utilizing BEMA technology
Chart-33: Advance in Orodispersible film for drug delivery
Chart-34: Cara therapeutics drug development
Chart-35: Cebranopadol overview
Chart-36: Cebranopadol MOA- Uniquely differentiate
Chart-37: Cebranopadol phase II clinical trial summary
Chart-37 (a): Cebranopadol phase II clinical trial summary
Chart-37 (b): Cebranopadol phase II clinical trial summary
Chart-38: Cebranopadol reduced Abuse Deterrent potential
Chart-39: Daiichi sankyo (Efficacy result of mirogabalin vs. Lyrica/Pregabalin)
Chart-40: A flow chart depicting a tier-based approach to evaluating the extractability of Opioid from an intact product for ingestion
Global Pain Management Drugs Market Research Report 2018
Published: 21-Mar-2018 Price: US 2900 Onwards Pages: 116
In this report, the global Pain Management Drugs market is valued at USD XX million in 2017 and is expected to reach USD XX million by the end of 2025, growing at a CAGR of XX% between 2017 and 2025.
Geographically, this report is segmented into several key Regions, with production, consumption, revenue (million USD), market share and growth rate of Pain Management Drugs in these regions, from 2013 to 2025 (forecast), covering
- North America
Global Opioids Drug Market Professional Survey Report 2018
Published: 14-Mar-2018 Price: US 3500 Onwards Pages: 111
This report studies Opioids Drug in Global market, especially in North America, China, Europe, Southeast Asia, Japan and India, with production, revenue, consumption, import and export in these regions, from 2013 to 2018, and forecast to 2025.
This report focuses on top manufacturers in global market, with production, price, revenue and market share for each manufacturer, covering
- Eli Lilly......
2018-2025 Opioids Drug Report on Global and United States Market, Status and Forecast, by Players, Types and Applications
Published: 09-Mar-2018 Price: US 3600 Onwards Pages: 129
This report studies the Opioids Drug market status and outlook of global and United States, from angles of players, regions, product types and end industries; this report analyzes the top players in global and United States market, and splits the Opioids Drug market by product type and application/end industries.
The global Opioids Drug market is valued at XX million USD in 2017 and is expected to reach XX million USD by the end of 2025, growing at a CAGR of......
Global Pain Partnering 2012 to 2018
Published: 01-Mar-2018 Price: US 1495 Onwards Pages: 200
""Delivery of this report will take 1-3 days after purchase."""
The Global Pain Partnering Terms and Agreements since 2012 report provides understanding and access to partnering deals and agreements entered into by the world's leading healthcare companies.
- Trends in partnering deals
- Top deals by value
- Deals listed by company A-Z, industry sector, stage of development, technology type
The report provides understanding and access to......
Visceral Pain - Pipeline Review, H1 2018
Published: 20-Feb-2018 Price: US 2000 Onwards Pages: 51
Global Markets Direct's latest Pharmaceutical and Healthcare disease pipeline guide Visceral Pain - Pipeline Review, H1 2018, provides an overview of the Visceral Pain (Central Nervous System) pipeline landscape.
Visceral pain is a type of nociceptive pain that comes from the internal organs. Symptoms include aches, cramps and diffuse pain. Treatment includes analgesics such as narcotics or NSAIDs and pain modifiers such as tricyclic antidepressants or anticonvulsants.
United States Opioids Drug Market Report 2018
Published: 20-Feb-2018 Price: US 3800 Onwards Pages: 108
In this report, the United States Opioids Drug market is valued at USD XX million in 2017 and is expected to reach USD XX million by the end of 2025, growing at a CAGR of XX% between 2017 and 2025.
Geographically, this report splits the United States market into seven regions:
- The West
- The Middle Atlantic
- New England
- The South
- The Midwest
with sales (volume), revenue (value), market share and growth rate of Opi......
China Morphine Sulfate Market Research Report 2018
Published: 19-Feb-2018 Price: US 3400 Onwards Pages: 102
The global Morphine Sulfate market is valued at XX million USD in 2016 and is expected to reach XX million USD by the end of 2022, growing at a CAGR of XX% between 2016 and 2022.
China plays an important role in global market, with market size of xx million USD in 2016 and will be xx million USD in 2022, with a CAGR of xx%.
This report studies the Morphine Sulfate development status and future trend in China, focuses on top players in China, also splits Morphine Sul......
Global Opioids Drug Sales Market Report 2018
Published: 13-Feb-2018 Price: US 4000 Onwards Pages: 112
In this report, the global Opioids Drug market is valued at USD XX million in 2017 and is expected to reach USD XX million by the end of 2025, growing at a CAGR of XX% between 2017 and 2025.
Geographically, this report split global into several key Regions, with sales (K Units), revenue (Million USD), market share and growth rate of Opioids Drug for these regions, from 2013 to 2025 (forecast), covering
- United States
Global Morphine Sulfate Market Professional Survey Report 2018
Published: 12-Feb-2018 Price: US 3500 Onwards Pages: 107
This report studies Morphine Sulfate in Global market, especially in North America, China, Europe, Southeast Asia, Japan and India, with production, revenue, consumption, import and export in these regions, from 2012 to 2016, and forecast to 2022.
This report focuses on top manufacturers in global market, with production, price, revenue and market share for each manufacturer, covering
- Mallinckrodt Pharmaceuticals
- Purdue Pharma
Value for Money
We believe in "optimum utilization of available budget and resources". While servicing our clients' (your) market research requirements, we keep the same approach in focus to help you get the best value for your $$s.
Ever Growing Inventory
Ranging from the smallest feasible / required data (datasheets, data facts, SWOT analysis, company profiles, etc) to full research reports that help you make decisions, our inventory is updated almost on a daily basis with the latest industry reports from domain experts that track more than 5000 niche sectors.
One Stop Solution
Need a custom research report on medical devices market? Require all available business intelligence on 3D printing industry? Exploring F&B sector of a particular country/region? RnRMarketResearch.com is your one-stop-solution to all market intelligence needs. We not only offer custom research and consulting services, we also "bundle" reports to meet your needs and help you fetch the data analysis you require for your business.
Dedicated Client Engagement
Not limited to only "finding" relevant reports for you, our client engagement team dedicates its efforts to understand your "business need" and accordingly maps available research data to help you move forward. Call "your" client engagement executive any time of your day and get your questions answered in order to make the correct business decision.
Saving Time and Efforts
Simply share your research requirement details with us and let us do all the hard work to find required intelligence for you. When you add up our "one stop solution" and "dedicated client engagement" services mentioned above, you obviously know the time and effort saving you do by working with us.
Working with Fortune 500 organizations, we understand the importance of being flexible for payments. Share your payment terms with us and we will surely match up to them to ensure you get access to required business intelligence data without having to wait for the payment to be done.
Post-Purchase Research Support
Have questions after reading a report / datasheet bought through us? Not sure about the methodology used for data available in the research? Talk to us / Share your questions with us and if required, we will connect you with the analyst(s)/author(s) of the report(s) and ensure you get satisfactory answers for the same. Need more data / analysis / report(s) on the topic of your research/project? The RnRMarketResearch.com team is here for you 24X7 to support you with your post-purchase requirements.
Subscription Offers & Packages (Get in touch with us for more details - firstname.lastname@example.org
/ +1 888 391 5441 )
- Ad Hoc
- Pay - as - you - go / Bucket Subscriptions
- Fixed Cost for #of reports
- Customize / Personalize as per your needs