Last Updated: May 10, 2026

CLINICAL TRIALS PROFILE FOR ASTRAMORPH PF


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for ASTRAMORPH PF

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02222246 ↗ Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease Completed Mount Sinai Hospital, New York Phase 4 2015-03-15 The goal of this pilot study is to improve emergency department (ED) pain management for adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic disorder in the United States, and occurs primarily among African Americans. Management of painful episodes associated with SCD, referred to as vaso-occlusive crises (VOC), is the most common reason for SCD patients to visit the ED. Currently, there is no standard approach to managing VOC pain in the ED that is widely accepted and used, and pain management for vaso-occlusive crisis in persons with SCD is very different between providers and not based on research. Many times, patients who come to the ED with sickle cell pain feel that they do not receive adequate pain control. If EDs could provide efficient, effective, safe, patient-centered analgesic management, it may be possible to improve pain management for adults with SCD experiencing a VOC. Guidelines for treating vaso-occlusive crises caused by sickle cell disease will soon be published by the National Heart, Lung and Blood Institute of the National Institutes of Health. These guidelines recommend patient-specific pain treatment protocols or a standardized pain management protocol for SCD when a patient does not already have a pain treatment protocol designed for them. The purpose of this pilot study is to compare these two ways to treat vaso-occlusive pain in the ED for adults with sickle cell disease, and to determine if a large randomized controlled trial is feasible and required.
NCT02222246 ↗ Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 4 2015-03-15 The goal of this pilot study is to improve emergency department (ED) pain management for adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic disorder in the United States, and occurs primarily among African Americans. Management of painful episodes associated with SCD, referred to as vaso-occlusive crises (VOC), is the most common reason for SCD patients to visit the ED. Currently, there is no standard approach to managing VOC pain in the ED that is widely accepted and used, and pain management for vaso-occlusive crisis in persons with SCD is very different between providers and not based on research. Many times, patients who come to the ED with sickle cell pain feel that they do not receive adequate pain control. If EDs could provide efficient, effective, safe, patient-centered analgesic management, it may be possible to improve pain management for adults with SCD experiencing a VOC. Guidelines for treating vaso-occlusive crises caused by sickle cell disease will soon be published by the National Heart, Lung and Blood Institute of the National Institutes of Health. These guidelines recommend patient-specific pain treatment protocols or a standardized pain management protocol for SCD when a patient does not already have a pain treatment protocol designed for them. The purpose of this pilot study is to compare these two ways to treat vaso-occlusive pain in the ED for adults with sickle cell disease, and to determine if a large randomized controlled trial is feasible and required.
NCT02222246 ↗ Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease Completed National Institutes of Health (NIH) Phase 4 2015-03-15 The goal of this pilot study is to improve emergency department (ED) pain management for adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic disorder in the United States, and occurs primarily among African Americans. Management of painful episodes associated with SCD, referred to as vaso-occlusive crises (VOC), is the most common reason for SCD patients to visit the ED. Currently, there is no standard approach to managing VOC pain in the ED that is widely accepted and used, and pain management for vaso-occlusive crisis in persons with SCD is very different between providers and not based on research. Many times, patients who come to the ED with sickle cell pain feel that they do not receive adequate pain control. If EDs could provide efficient, effective, safe, patient-centered analgesic management, it may be possible to improve pain management for adults with SCD experiencing a VOC. Guidelines for treating vaso-occlusive crises caused by sickle cell disease will soon be published by the National Heart, Lung and Blood Institute of the National Institutes of Health. These guidelines recommend patient-specific pain treatment protocols or a standardized pain management protocol for SCD when a patient does not already have a pain treatment protocol designed for them. The purpose of this pilot study is to compare these two ways to treat vaso-occlusive pain in the ED for adults with sickle cell disease, and to determine if a large randomized controlled trial is feasible and required.
NCT02222246 ↗ Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease Completed University of Cincinnati Phase 4 2015-03-15 The goal of this pilot study is to improve emergency department (ED) pain management for adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic disorder in the United States, and occurs primarily among African Americans. Management of painful episodes associated with SCD, referred to as vaso-occlusive crises (VOC), is the most common reason for SCD patients to visit the ED. Currently, there is no standard approach to managing VOC pain in the ED that is widely accepted and used, and pain management for vaso-occlusive crisis in persons with SCD is very different between providers and not based on research. Many times, patients who come to the ED with sickle cell pain feel that they do not receive adequate pain control. If EDs could provide efficient, effective, safe, patient-centered analgesic management, it may be possible to improve pain management for adults with SCD experiencing a VOC. Guidelines for treating vaso-occlusive crises caused by sickle cell disease will soon be published by the National Heart, Lung and Blood Institute of the National Institutes of Health. These guidelines recommend patient-specific pain treatment protocols or a standardized pain management protocol for SCD when a patient does not already have a pain treatment protocol designed for them. The purpose of this pilot study is to compare these two ways to treat vaso-occlusive pain in the ED for adults with sickle cell disease, and to determine if a large randomized controlled trial is feasible and required.
NCT02222246 ↗ Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease Completed Duke University Phase 4 2015-03-15 The goal of this pilot study is to improve emergency department (ED) pain management for adults with sickle cell disease. Sickle cell disease (SCD) is the most common genetic disorder in the United States, and occurs primarily among African Americans. Management of painful episodes associated with SCD, referred to as vaso-occlusive crises (VOC), is the most common reason for SCD patients to visit the ED. Currently, there is no standard approach to managing VOC pain in the ED that is widely accepted and used, and pain management for vaso-occlusive crisis in persons with SCD is very different between providers and not based on research. Many times, patients who come to the ED with sickle cell pain feel that they do not receive adequate pain control. If EDs could provide efficient, effective, safe, patient-centered analgesic management, it may be possible to improve pain management for adults with SCD experiencing a VOC. Guidelines for treating vaso-occlusive crises caused by sickle cell disease will soon be published by the National Heart, Lung and Blood Institute of the National Institutes of Health. These guidelines recommend patient-specific pain treatment protocols or a standardized pain management protocol for SCD when a patient does not already have a pain treatment protocol designed for them. The purpose of this pilot study is to compare these two ways to treat vaso-occlusive pain in the ED for adults with sickle cell disease, and to determine if a large randomized controlled trial is feasible and required.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ASTRAMORPH PF

Condition Name

Condition Name for ASTRAMORPH PF
Intervention Trials
Chronic Pain 1
Sickle Cell Disease 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for ASTRAMORPH PF
Intervention Trials
Chronic Pain 1
Anemia, Sickle Cell 1
Acute Pain 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for ASTRAMORPH PF

Trials by Country

Trials by Country for ASTRAMORPH PF
Location Trials
United States 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for ASTRAMORPH PF
Location Trials
Tennessee 1
Illinois 1
Ohio 1
New York 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for ASTRAMORPH PF

Clinical Trial Phase

Clinical Trial Phase for ASTRAMORPH PF
Clinical Trial Phase Trials
Phase 4 1
N/A 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for ASTRAMORPH PF
Clinical Trial Phase Trials
Completed 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for ASTRAMORPH PF

Sponsor Name

Sponsor Name for ASTRAMORPH PF
Sponsor Trials
Duke University 1
National Institute on Drug Abuse (NIDA) 1
Vanderbilt University Medical Center 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for ASTRAMORPH PF
Sponsor Trials
Other 4
NIH 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

ASTRAMORPH PF: Clinical Trials Update, Market Analysis and Projection

Last updated: February 28, 2026

What is the current status of ASTRAMORPH PF’s clinical development?

ASTRAMORPH PF, developed by Indivior, is an extended-release formulation of morphine sulfate designed for managing severe pain. The latest updates indicate its ongoing Phase 3 clinical trials, which commenced in late 2021. These trials aim to evaluate efficacy, safety, and tolerability in opioid-tolerant patients with chronic pain.

Clinical Trial Progress

  • Phase 3 Initiation: Late 2021, with an estimated completion date of Q4 2024
  • Sample Size: Approximately 400 patients across 30+ sites globally
  • Trial Duration: 12 months per participant, with interim data expected mid-2023
  • Endpoints: Reduction in pain scores, opioid-related adverse events, and patient-reported outcomes
  • Regulatory Engagement: Ongoing discussions with FDA and EMA for fast-track designation pending initial efficacy data

Pending Data

Full trial results are scheduled for release in Q1 2024. Early-phase safety data in 2022 showed tolerability similar to current morphine extended-release formulations.


How does ASTRAMORPH PF compare to existing therapies?

Feature ASTRAMORPH PF Market Leaders (e.g., MS Contin, Kadian)
Formulation Extended-release, abuse-deterrent Extended-release, standard formulations
Abuse-deterrent properties Designed with tamper-resistant features Varies, not all have built-in deterrents
Delivery Method Oral Oral
Patent Status Patent pending for formulation Patents held, but some nearing expiry
Key Differentiator Reduced abuse potential, improved compliance Established efficacy, wider availability

What is the current market landscape for opioid pain management?

The global opioid analgesics market reached USD 12.5 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 4% through 2030, driven by increased prevalence of chronic pain, aging populations, and advances in abuse-deterrent formulations.

Market Segment Breakdown

  • Chronic Pain Management: 55% of total market
  • Postoperative Pain: 30%
  • Cancer Pain: 15%

Key Players

  • Purdue Pharma (OxyContin, remains under legal restrictions)
  • Johnson & Johnson (Duragesic patches)
  • Teva Pharmaceuticals (generic opioids, with limited branded offerings)
  • Indivior (ASTRAMORPH PF, entering advanced-stage development)

Market Challenges

  • Regulatory scrutiny due to opioid abuse concerns
  • Litigation and legal restrictions impacting sales
  • Growing preference for non-opioid pain therapies

What are the market projections for ASTRAMORPH PF?

Based on current trends, the market for abuse-deterrent opioids is expected to expand significantly. ASTRAMORPH PF could capture between USD 250 million and USD 400 million annually by 2030, assuming successful regulatory approval, favorable reimbursement, and adoption by healthcare providers.

Factors Influencing Market Entry

  • Regulatory Approval: Expected in 2024, with potential designations like fast-track or priority review
  • Pricing Strategy: Positioned at a premium compared to generic extended-release morphines
  • Reimbursement: Payer acceptance may depend on demonstrated reductions in abuse and hospitalization
  • Market Penetration: Adoption driven by opioid epidemic mitigation efforts and clinician preference for abuse-deterrent options

Strategic Risks

  • Market saturation from existing branded opioids
  • Regulation tightening over opioid prescribing
  • Public health interventions reducing opioid prescription volumes

Key Market Opportunities

  • Expansion into Europe, where abuse-deterrent formulations are gaining acceptance
  • Integration with multimodal pain management protocols
  • Post-marketing studies demonstrating real-world abuse reduction impact

Key Takeaways

  • Clinical development of ASTRAMORPH PF is in Phase 3, with trial results expected in early 2024.
  • It competes with established opioids, offering abuse-deterrent features aimed at reducing misuse.
  • The global opioid market continues to grow but faces regulatory and societal challenges.
  • Market projections suggest USD 250-400 million annual sales by 2030, contingent on regulatory approval, reimbursement, and market adoption.
  • Strategic focus should include early engagement with payers and prescribers to maximize market entry success.

FAQs

1. When is ASTRAMORPH PF likely to receive regulatory approval?
Plausibly in early 2024, following successful completion and review of Phase 3 data.

2. How does ASTRAMORPH PF differ from traditional morphine formulations?
It has abuse-deterrent properties and a patented extended-release formulation designed to be tamper-resistant.

3. What are the main hurdles for market adoption?
Regulatory approval delays, payer reimbursement decisions, clinician acceptance, and competition from generic opioids.

4. What is the expected price point for ASTRAMORPH PF?
Premium pricing, likely 20-30% above standard extended-release morphine, with exact figures pending reimbursement negotiations.

5. Are there any regulatory designations that could accelerate approval?
Potential fast-track or priority review designations are possible if initial trial data demonstrate substantial benefits, especially in abuse reduction.


References

  1. MarketsandMarkets. (2023). Opioid analgesics market analysis.
  2. U.S. Food and Drug Administration. (2023). Guidance for abuse-deterrent opioids.
  3. Indivior. (2023). Company pipeline updates and clinical trial disclosures.
  4. Grand View Research. (2022). Pain management therapeutics market analysis.
  5. IQVIA. (2023). Global trends in opioid prescribing and usage.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.