EVENT PULSE PREVIEWS: ABUSE RESISTANT OPIOIDS 2010
Healthcare professionals, managed care organizations, and regulatory agencies continue to struggle in trying to balance the clear therapeutic benefits of opioid pain therapies with the potential risks associated with abuse, diversion, addiction and overdose. Meanwhile, pharmaceutical manufacturers’ pipelines include early- and late-stage candidates with a variety of abuse-deterrent mechanisms, and the FDA is in the process of developing the first class-wide risk evaluation and mitigation strategy (REMS) programs for opioids. Event Pulse Preview: Abuse Resistant Opioids provides an overview of key marketed opioid brands, early- and late-stage pipeline drugs, and estimated patient share of such products through 2015. This report will also gauge awareness and the anticipated impact of the FDA’s proposed opioid risk evaluation and mitigation strategy (REMS) programs for opioids.
Event Pulse Previews is a syndicated report series that evaluates current and anticipated trends and practices in hot-button therapeutic areas. These reports provide near- and mid-term outlooks on the shifting landscape of new market entries, treatment algorithms and clinical data.
Healthcare professionals, managed care organizations, and regulatory agencies continue to struggle in trying to balance the clear therapeutic benefits of opioid pain therapies with the potential risks associated wit
h abuse, diversion, addiction and overdose. Meanwhile, pharmaceutical manufacturers’ pipelines include early- and late-stage candidates with a variety of abuse-deterrent mechanisms, and the FDA is in the process of developing the first class-wide risk evaluation and mitigation strategy (REMS) programs for opioids. ]]>
Event Pulse Preview: Abuse Resistant Opioids 2010 provides an overview of key marketed opioid brands, early- and late-stage pipeline drugs, and estimated patient share of such products through 2015. This report will also gauge awareness and the anticipated impact of the FDA’s proposed opioid risk evaluation and mitigation strategy (REMS) programs for opioids.
PROJECT DETAILS
Scope
• Assessment of unmet needs and current awareness/perceptions of opioids in development
• Overview of key marketed brands, as well as early- and late-stage pipeline drugs
• Estimated patient share to 2015 of marketed brands, generics, and key late-stage pipeline opioid drugs
• Identification of future market events and anticipated impact on opioid revenues
• Synthesized comparison to similar data collected in the October 2009 iteration of this study
Reasons to Purchase
• Benchmark key late-stage pipeline opioids against current market leading brands
• Assess anticipated impact of recent FDA approvals, including abuse resistant OxyContin and Exalgo
• Assess impact of recent entries to the market, including Embeda, Nucynta, and Onsolis
• Gauge anticipated impact of the FDA’s proposed REMS for opioids
• Compare findings to similar data collected in the October 2009 iteration of this study
Contributing Experts
• MCO Pharmacy Directors (10 Telephone In-Depth Interviews)
• Primary Care Physicians (50 Online Interviews)
• Pain Management Physicians (25 Online Interviews)
• Rheumatologists (25 Online Interviews)
Methodology
Event Pulse Previews utilize our TwinTrack methodology, which has been our most popular service since 2003. It consists of an internet survey fielded simultaneously with a sizeable sample of in-depth telephone interviews. TwinTrack is unique: No other vendor has the capability to deliver, at Internet speed, a qualitative sample large enough to match your needs for robust findings and meaningful, qualitative insights. Our credentialed and experienced consultants moderate high-caliber, peer-level interviews.
Outline
o Current Trends in Opioid Prescribing
o Awareness and Impact of Recent Opioid Product Launches
o Awareness and Impact of FDA proposed REMS
o Perceived Need for Abuse Resistant Opioids
o Response to Abuse Resistant Mechanisms
o Awareness of Products in Development
o Anticipated Impact of New Abuse Resistant Opioids
o Anticipated Use of Products in Development
o MCOs – Current Formulary for Opioid Products
o MCOs – Response to New Opioid Products and FDA proposed REMS
o MCOs – Perceived Need for Abuse Resistant Opioids
o MCOS – Response to Abuse Resistant Mechanisms
o MCOs – Anticipated Formulary Status for Products in Development
Deliverables
• Customized PowerPoint Report deck with conclusions, recommendations, and detailed findings, including graphics and selected verbatims
• Synthesized comparison to data collected in October 2009
• Data in Excel, which includes full question/response history for each respondent
• Final Report and Data are synthesized from both Internet and Telephone tracks
Timeline
• Data collected June 30, 2010 – July 16, 2010
• Report and data available July 23, 2010
Price
• $9,500 all-inclusive
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DETAILED PRODUCT LIST
Long-Acting / Extended-Release:
• Avinza (morphine extended-release)
• Embeda (morphine extended-release + naltrexone)
• Exalgo (hydromorphone controlled-released)
• Kadian (morphine extended-release)
• Oramorph SR (morphine sustained-release)
• Opana ER (oxymorphone)
• Ultram ER (tramadol extended- release)
• Duragesic / generic fentanyl patch
• Methadose / generic methadone
• MS-Contin / generic morphine extended-release
• OxyContin (new abuse resistant formulation)
In development: Egalet morphine, ELI-216 (oxycodone + naltrexone), Remoxy (oxycodone),TRANSDUR-Sufentanil Patch, TPM-01 / oxycodone Short-Acting / Immediate-Release:
• Nucynta (tapentadol)
• Sprix (ketorolac tromethamine)
• Branded and generic hydrocodone products (Lortab, Lorcet, Vicodin, etc.)
• Branded and generic hydromorphone products (Dilaudid, etc.)
• Branded and generic morphine products (MSIR, morphine sulfate IR)
• Branded and generic oxycodone products (OxyIR, Percocet, Percodan, Endocet, etc.)
• Branded and generic tramadol products
• (Ultram, Ultracet, etc.)
In development: Acurox (oxycodone + niacin), Acurox without niacin, Hydromorphone Nasal Spray, MoxDuo IR (morphine + oxycodone), MoxDuo CR
Breakthrough Pain:
• Actiq (transmucosal fentanyl)
• Fentora (fentanyl buccal tablet)
• Onsolis (fentanyl buccal soluble film)
In development: Ereska (intranasal ketamine), Fentanyl TAIFUN (fentanyl inhalant), FENTOS tape (transdermal fentanyl), Instanyl (intranasal fentanyl), PecFent (intranasal fentanyl), Rapinyl (sublingual fentanyl)
EVENT PULSE PREVIEWS: ABUSE RESISTANT OPIOIDS 2010
Event Pulse Preview: Abuse Resistant Opioids provides an overview of key marketed opioid brands, early- and late-stage pipeline drugs, and estimated patient share of such products through 2015. This report will also gauge awareness and the anticipated impact of the FDA’s proposed opioid risk evaluation and mitigation strategy (REMS) programs for opioids.
Event Pulse Previews is a syndicated report series that evaluates current and anticipated trends and practices in hot-button therapeutic areas. These reports provide near- and mid-term outlooks on the shifting landscape of new market entries, treatment algorithms and clinical data.
PROJECT DETAILS
Scope
- Assessment of unmet needs and current awareness/perceptions of opioids in development
- Overview of key marketed brands, as well as early- and late-stage pipeline drugs
- Estimated patient share to 2015 of marketed brands, generics, and key late-stage pipeline opioid drugs
- Identification of future market events and anticipated impact on opioid revenues
- Synthesized comparison to similar data collected in the October 2009 iteration of this study
Reasons to Purchase
- Benchmark key late-stage pipeline opioids against current market leading brands
- Assess anticipated impact of recent FDA approvals, including abuse resistant OxyContin and Exalgo
- Assess impact of recent entries to the market, including Embeda, Nucynta, and Onsolis
- Gauge anticipated impact of the FDA’s proposed REMS for opioids
- Compare findings to similar data collected in the October 2009 iteration of this study
Contributing Experts
- MCO Pharmacy Directors (10 Telephone In-Depth Interviews)
- Primary Care Physicians (50 Online Interviews)
- Pain Management Physicians (25 Online Interviews)
- Rheumatologists (25 Online Interviews)
Methodology
Event Pulse Previews utilize our TwinTrack methodology, which has been our most popular service since 2003. It consists of an internet survey fielded simultaneously with a sizeable sample of in-depth telephone interviews. TwinTrack is unique: No other vendor has the capability to deliver, at Internet speed, a qualitative sample large enough to match your needs for robust findings and meaningful, qualitative insights. Our credentialed and experienced consultants moderate high-caliber, peer-level interviews.
Outline
- Current Trends in Opioid Prescribing
- Awareness and Impact of Recent Opioid Product Launches
- Awareness and Impact of FDA proposed REMS
- Perceived Need for Abuse Resistant Opioids
- Response to Abuse Resistant Mechanisms
- Awareness of Products in Development
- Anticipated Impact of New Abuse Resistant Opioids
- Anticipated Use of Products in Development
- MCOs – Current Formulary for Opioid Products
- MCOs – Response to New Opioid Products and FDA proposed REMS
- MCOs – Perceived Need for Abuse Resistant Opioids
- MCOs – Response to Abuse Resistant Mechanisms
- MCOs – Anticipated Formulary Status for Products in Development
DETAILED PRODUCT LIST
Long-Acting / Extended-Release:
- Avinza (morphine extended-release)
- Embeda (morphine extended-release + naltrexone)
- Exalgo (hydromorphone controlled-released)
- Kadian (morphine extended-release)
- Oramorph SR (morphine sustained-release)
- Opana ER (oxymorphone)
- Ultram ER (tramadol extended- release)
- Duragesic / generic fentanyl patch
- Methadose / generic methadone
- MS-Contin / generic morphine extended-release
- OxyContin (new abuse resistant formulation)
- In development: Egalet morphine, ELI-216 (oxycodone + naltrexone), Remoxy (oxycodone),TRANSDUR-Sufentanil Patch, TPM-01 / oxycodone
Short-Acting / Immediate-Release:
- Nucynta (tapentadol)
- Branded and generic hydrocodone products (Lortab, Lorcet, Vicodin, etc.)
- Branded and generic hydromorphone products (Dilaudid, etc.)
- Branded and generic morphine products (MSIR, morphine sulfate IR)
- Branded and generic oxycodone products (OxyIR, Percocet, Percodan, Endocet, etc.)
- Branded and generic tramadol products (Ultram, Ultracet, etc.)
- In development: Acurox (oxycodone + niacin), Acurox without niacin, Hydromorphone Nasal Spray, MoxDuo IR (morphine + oxycodone), MoxDuo CR
Breakthrough Pain:
- Actiq (transmucosal fentanyl)
- Fentora (fentanyl buccal tablet)
- Onsolis (fentanyl buccal soluble film)
- In development: Ereska (intranasal ketamine), Fentanyl TAIFUN (fentanyl inhalant), FENTOS tape (transdermal fentanyl), Instanyl (intranasal fentanyl), PecFent (intranasal fentanyl), Rapinyl (sublingual fentanyl)