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  4. > Moderate to Severe Pain: Novel Abuse Deterrent Formulation Technologies and Emergence of Novel Mechanisms in the Management of Pain

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.

Table Of Contents

Moderate to Severe Pain: Novel Abuse Deterrent Formulation Technologies and Emergence of Novel Mechanisms in the Management of Pain
1. Management of Pain
- Introduction
- 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
- Overview of Marketed drugs for moderate to severe pain and neuropathic pain
- Advantages and Limitations of non-opioid drugs and overview of marketed 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
e. IntelliPaste
i. Implantable pump for intrathecal delivery
k. Small molecule delivery
l. Bio-MD-prodrugs platform
m. Ligand activated Therapy (LAT)
q. Inspirion delivery Technologies
r. Intellitab Technology
s. Trigger lock platform -Micropump
t. Fenrock
u. Smart Patch PNS system
5. Pipeline analysis of Novel Technologies and new mechanisms in Pain management
a. Multi-day formulation of Tramadol
b. Bio-MD Platform
c. Angiotension II antagonist
d. Anti-NGF
e. Ligand Activate Therapy
f. Nav1. 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. Oromucosal delivery
m. Opioid alternatives (dexmedetomidine)
n. Steroidal intraarticular 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. Topical clonidine gel
g. Topical ketamine and amitraline
h. Eladur
i. GRC-17536
j. DWP05195
7. FDA Perspective on Abuse deterrent formulations (Opioids)
Companies mentioned:
- AbbVie
- AcelRx
- Acorda Therapeutics
- Actavis
- Acura Pharma
- Altus formulations
- Amorsa Therapeutics
- AstraZeneca
- BioDelivery Sciences International Inc
- Cara Therapeutics
- Catalent
- Charleston
- Collegium Pharma
- Convergence
- Daiichi
- Daewoong
- Depomed
- Durect
- Egalet
- Eli Lilly
- Elite Pharma
- Endo
- Flamel Technologies
- Flexion Therapeutics
- Glenmark
- Grunenthal
- Immune Pharmaceuticals
- Impax Pharmaceuticals
- Inspirion Delivery technologies
- Intelli Pharmaceutics
- Johnson and Johnson
- KemPharm
- Kineta
- Kunwha Pharmaceutical
- Medallion Therapeutics
- Nektar
- Orbis Biosciences
- Orexo
- Pain Therapeutics
- Pfizer
- Purdue
- Recro
- Relmada Therapeutics
- Signature Therapeutics
- Spinifex pharma
- SPR Therapeutics
- Teikoku
- Teva
- Trevena Inc
- Tris Pharma
- Valeant
- Xenon Pharma
- XenoPort

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 NSAIDs
Table-9: Benefits of Sublingual Microtablets vs. IV morphine Patient Controlled Analgesia

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 2018: 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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