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Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR RELISTOR


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All Clinical Trials for Relistor

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00672139 ↗ Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness Completed Progenics Pharmaceuticals, Inc. Phase 4 2008-07-01 This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.
NCT00672139 ↗ Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness Completed Bausch Health Americas, Inc. Phase 4 2008-07-01 This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.
NCT00672139 ↗ Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness Completed Valeant Pharmaceuticals International, Inc. Phase 4 2008-07-01 This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.
NCT00672477 ↗ Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness Completed Progenics Pharmaceuticals, Inc. Phase 4 2008-06-01 This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.
NCT00672477 ↗ Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness Completed Bausch Health Americas, Inc. Phase 4 2008-06-01 This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.
NCT00672477 ↗ Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness Completed Valeant Pharmaceuticals International, Inc. Phase 4 2008-06-01 This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.
NCT00804141 ↗ Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation Completed Pfizer Phase 3 2008-12-03 This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipation in participants with nonmalignant pain. The study consists of a 2-week screening period, a 48-week open-label treatment period and a 2 week follow-up period. Participants will need to agree to self-administer SC injections, complete daily diaries, and check-in via a daily telephone call during the study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Relistor

Condition Name

Condition Name for Relistor
Intervention Trials
Opioid-Induced Constipation 4
Constipation 4
Pharyngeal Dysfunction 2
Gastric Motility Disorder 1
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Condition MeSH

Condition MeSH for Relistor
Intervention Trials
Constipation 10
Opioid-Induced Constipation 7
Myocardial Ischemia 1
Coronary Disease 1
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Clinical Trial Locations for Relistor

Trials by Country

Trials by Country for Relistor
Location Trials
United States 65
Canada 17
Australia 5
Spain 3
Korea, Republic of 3
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Trials by US State

Trials by US State for Relistor
Location Trials
Pennsylvania 4
North Carolina 4
Florida 4
Ohio 3
New Jersey 3
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Clinical Trial Progress for Relistor

Clinical Trial Phase

Clinical Trial Phase for Relistor
Clinical Trial Phase Trials
Phase 4 10
Phase 3 4
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Relistor
Clinical Trial Phase Trials
Completed 10
Unknown status 2
Withdrawn 2
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Clinical Trial Sponsors for Relistor

Sponsor Name

Sponsor Name for Relistor
Sponsor Trials
Bausch Health Americas, Inc. 4
Valeant Pharmaceuticals International, Inc. 4
Wyeth is now a wholly owned subsidiary of Pfizer 4
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Sponsor Type

Sponsor Type for Relistor
Sponsor Trials
Other 17
Industry 16
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Clinical Trials, Market Analysis, and Projections for Relistor (Methylnaltrexone Bromide)

Introduction to Relistor

Relistor, also known as methylnaltrexone bromide, is a peripherally acting mu-opioid receptor antagonist. It is primarily used for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain and those with advanced illness. The drug is available in both subcutaneous injection and oral tablet forms.

Clinical Trials and Efficacy

Key Findings

Clinical trials have demonstrated the efficacy of Relistor in treating OIC. In a study involving 150 patients with chronic non-cancer pain, Relistor 12 mg administered once daily showed significant improvement in spontaneous bowel movements (SBM) compared to the placebo group. The study found that 38% of patients in the Relistor group achieved SBM within 4 hours of the first dose, compared to 10% in the placebo group[1].

Safety Profile

While effective, Relistor has a notable safety profile. Serious adverse reactions include gastrointestinal perforation, severe or persistent diarrhea, and opioid withdrawal symptoms. Patients with known or suspected gastrointestinal obstruction are contraindicated from using Relistor due to the risk of gastrointestinal perforation. Common adverse reactions include abdominal pain, nausea, diarrhea, hyperhidrosis, and flatulence[1][4].

Impact on Hospitalization and Healthcare Costs

A study published in Advances in Therapy highlighted the cost and outcome benefits of using Relistor in the emergency department. Patients treated with Relistor had a 64% decreased odds of hospitalization and shorter lengths of stay compared to those not treated with OIC prescription medications. Additionally, the study found a significant reduction in healthcare costs, with a $781 reduction per OIC ED encounter and a $392 reduction in healthcare costs during the 30-day post-discharge period[3].

Market Analysis

Market Segment Dominance

The mu-opioid receptor antagonists segment, which includes Relistor, is expected to hold a large market share in the opioid-induced constipation market. This dominance is attributed to the availability of various products suitable for different symptoms of OIC and the ongoing research activities in this segment. Other notable drugs in this class include Naldemedine (Symproic), Naloxegol (Movantik), and Alvimopan (Entereg)[5].

Product Availability and Effectiveness

Relistor's availability in both subcutaneous injection and oral tablet forms enhances its market appeal. It is often considered more effective at reversing OIC compared to other drugs in its class. This versatility and efficacy are expected to drive the segment and contribute to global market revenue over the forecast period[5].

Market Projections

Forecast and Trends

The global opioid-induced constipation market is projected to grow significantly over the next few years. The mu-opioid receptor antagonists segment, led by drugs like Relistor, is anticipated to continue its dominance. The market trends report forecasts growth up to 2029, driven by increasing research activities, the launch of new products, and the rising prevalence of opioid use for pain management[5].

Economic Impact

The economic benefits of using Relistor and other OIC prescription medications are substantial. By reducing hospitalization rates and lengths of stay, these medications can lead to significant cost savings for healthcare systems. The study mentioned earlier highlighted a reduction in healthcare costs per OIC ED encounter, which can have a cumulative positive impact on healthcare economics[3].

Regulatory and Development Aspects

Regulatory Approvals

Relistor has received FDA approval for the treatment of OIC in adult patients with chronic non-cancer pain and those with advanced illness. It has also been under development for other indications, including nonalcoholic fatty liver disease, postoperative ileus, and unresectable adenocarcinoma of the pancreas, although these are not yet approved[2][4].

Patent and Cash Flow Considerations

The net present value (NPV) model for Relistor, as analyzed by GlobalData, takes into account factors such as patent law, regulatory approval processes, and cash flows. This model helps in evaluating the drug's value and potential success rates at different stages of development. Understanding these factors is crucial for investors and pharmaceutical companies to make informed decisions[2].

Conclusion

Relistor is a significant player in the treatment of opioid-induced constipation, backed by robust clinical trials and a favorable market position. Its efficacy in improving bowel movements and reducing healthcare costs makes it a valuable option for patients and healthcare systems. As the market continues to grow, Relistor is poised to remain a dominant force in the mu-opioid receptor antagonists segment.

Key Takeaways

  • Efficacy: Relistor significantly improves spontaneous bowel movements in patients with OIC.
  • Safety: It has a notable safety profile, including risks of gastrointestinal perforation and opioid withdrawal symptoms.
  • Market Dominance: The mu-opioid receptor antagonists segment, led by Relistor, is expected to hold a large market share.
  • Economic Benefits: Relistor reduces hospitalization rates and healthcare costs.
  • Regulatory Status: FDA-approved for OIC treatment, with ongoing development for other indications.

FAQs

Q: What is Relistor used for?

A: Relistor is used for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain and those with advanced illness.

Q: What are the common adverse reactions associated with Relistor?

A: Common adverse reactions include abdominal pain, nausea, diarrhea, hyperhidrosis, and flatulence.

Q: How does Relistor impact healthcare costs?

A: Relistor reduces hospitalization rates and lengths of stay, leading to significant cost savings for healthcare systems.

Q: Is Relistor available in different forms?

A: Yes, Relistor is available in both subcutaneous injection and oral tablet forms.

Q: What is the market projection for Relistor and similar drugs?

A: The mu-opioid receptor antagonists segment, led by Relistor, is expected to continue its dominance and drive market growth up to 2029.

Sources

  1. PRI Healthcare Solutions: RELISTOR - PRI Healthcare Solutions.
  2. GlobalData: Net Present Value Model: Relistor.
  3. PR Newswire: New Data on Cost Impact of Treating Opioid-Induced Constipation.
  4. Pfizer Labeling: RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection.
  5. Mordor Intelligence: Global Opioid Induced Constipation Market Trends.

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