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Last Updated: May 17, 2025

CLINICAL TRIALS PROFILE FOR NUBAIN


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All Clinical Trials for Nubain

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00707824 ↗ Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus Completed Mahidol University Phase 4 2000-06-01 Can epidural nalbuphine reduce incidence or severity of epidural morphine induced pruritus in patient undergoing cesarean section?
NCT00947284 ↗ Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity Terminated University of California, San Francisco N/A 2010-01-01 In previous clinical studies of post-surgical pain the investigators found that nalbuphine (Nubain), a narcotic pain killer, relieves pain more effectively when combined with low-dose naloxone (Narcan), a drug that is used to treat narcotic overdose. This finding was particularly true in men. The purpose of this study is to find out if nalbuphine combined with naloxone is more effective in relieving experimentally produced pain than either drug alone. A second reason for this study is to find out if study medications work more effectively in women or in men. Subjects will come to the University of California at San Francisco (UCSF) Clinical Research Center (CRC) for 4 study visits. The first visit will be a 2-hour screening to assess the subject for study eligibility. During the other three visits, the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
NCT01380197 ↗ Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally Completed Atlanta Clinical and Translational Science Institute Phase 3 2010-05-26 The pathophysiology of sickle cell disease (SCD) manifestations, are complex with interactions of intracellular hemoglobin, membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes are thought to result from ischemia caused when small blood vessels are occluded by misshapen, inflexible erythrocytes. Painful episodes are the most common cause of hospitalization, morbidity, and impairment for SCD patients. There is no therapy that completely prevents or directly aborts painful events for all patients. Consequently, treatment for acute VOC is primarily supportive using hydration and medicinal pain control. Every pain medication has the potential to relieve pain but is associated with significant limitations and side effects. The primary hypothesis to be tested in this double blind, randomized controlled trial is that Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes of acute chest syndrome. The investigators also expect subjects will report fewer side effects from respiratory depression, abdominal distention from reduced peristalsis, reduced histamine release causing pruritis and still be provided adequate pain control. Further hypotheses to be tested is ability to recruit patient participants while being treated in the Emergency Department and that continuous infusion of Nalbuphine with accompanying patient controlled analgesia (PCA) is safe and effective in controlling pain, requiring less total opiates consumption, while decreasing length of hospitalization.
NCT01380197 ↗ Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally Completed Children's Healthcare of Atlanta Phase 3 2010-05-26 The pathophysiology of sickle cell disease (SCD) manifestations, are complex with interactions of intracellular hemoglobin, membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes are thought to result from ischemia caused when small blood vessels are occluded by misshapen, inflexible erythrocytes. Painful episodes are the most common cause of hospitalization, morbidity, and impairment for SCD patients. There is no therapy that completely prevents or directly aborts painful events for all patients. Consequently, treatment for acute VOC is primarily supportive using hydration and medicinal pain control. Every pain medication has the potential to relieve pain but is associated with significant limitations and side effects. The primary hypothesis to be tested in this double blind, randomized controlled trial is that Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes of acute chest syndrome. The investigators also expect subjects will report fewer side effects from respiratory depression, abdominal distention from reduced peristalsis, reduced histamine release causing pruritis and still be provided adequate pain control. Further hypotheses to be tested is ability to recruit patient participants while being treated in the Emergency Department and that continuous infusion of Nalbuphine with accompanying patient controlled analgesia (PCA) is safe and effective in controlling pain, requiring less total opiates consumption, while decreasing length of hospitalization.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nubain

Condition Name

Condition Name for Nubain
Intervention Trials
Conscious Sedation Failure During Procedure 1
Healthy 1
Nalbuphine 1
Opioid Abuse 1
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Condition MeSH

Condition MeSH for Nubain
Intervention Trials
Opioid-Related Disorders 1
Rotator Cuff Injuries 1
Anemia, Sickle Cell 1
Acute Chest Syndrome 1
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Clinical Trial Locations for Nubain

Trials by Country

Trials by Country for Nubain
Location Trials
United States 2
Mexico 1
Canada 1
Thailand 1
Egypt 1
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Trials by US State

Trials by US State for Nubain
Location Trials
Georgia 1
California 1
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Clinical Trial Progress for Nubain

Clinical Trial Phase

Clinical Trial Phase for Nubain
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Nubain
Clinical Trial Phase Trials
Completed 4
Terminated 1
Unknown status 1
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Clinical Trial Sponsors for Nubain

Sponsor Name

Sponsor Name for Nubain
Sponsor Trials
Atlanta Clinical and Translational Science Institute 1
Children's Healthcare of Atlanta 1
Hospital Universitario Dr. Jose E. Gonzalez 1
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Sponsor Type

Sponsor Type for Nubain
Sponsor Trials
Other 7
Industry 1
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Nalbuphine (NUBAIN): Clinical Trials Update, Market Analysis, and Projections

Introduction to Nalbuphine (NUBAIN)

Nalbuphine, marketed under the brand name NUBAIN, is a mixed opioid agonist-antagonist that has been in use for several decades, primarily for pain management. Recently, it has been under investigation for various new indications, including chronic cough, pruritus, and other conditions. Here, we will delve into the current clinical trials, market analysis, and future projections for nalbuphine.

Clinical Trials Update

Prurigo Nodularis (PN) and Pruritus

Trevi Therapeutics is conducting a Phase 2b/3 clinical trial known as the PRISM trial to evaluate the safety and efficacy of nalbuphine ER in patients with severe pruritus associated with prurigo nodularis (PN). This randomized, double-blind, placebo-controlled trial aims to enroll approximately 240 patients across 50 centers in the U.S. and Europe. Despite slower-than-anticipated enrollment due to competition from other trials and site start-up delays in Europe, the trial is ongoing, with top-line data expected in the future[1].

Chronic Cough in Idiopathic Pulmonary Fibrosis (IPF) and Refractory Chronic Cough (RCC)

Trevi Therapeutics is also conducting a Phase 2 trial to evaluate the efficacy, safety, and tolerability of nalbuphine ER for chronic cough in patients with IPF. This trial is a randomized, double-blind, placebo-controlled, two-treatment, two-period crossover study involving up to 56 patients. Enrollment is underway, with all remaining clinical sites expected to be activated by the end of the relevant period. Top-line data from this trial are anticipated in the second half of the respective year[1].

Hepatic Impairment and Primary Biliary Cholangitis (PBC)

A Phase 1b single ascending dose study in subjects with mild and moderate liver impairment has been completed. The study showed no serious adverse events, and the safety and pharmacokinetic profile supports the planning of a Phase 2 trial for pruritus associated with PBC. Data from this study will also be used to support a New Drug Application (NDA) submission for nalbuphine ER for pruritus in PN[1].

Levodopa-Induced Dyskinesia (LID) in Parkinson’s Disease

Trevi Therapeutics has written the protocol for a Phase 2 trial of nalbuphine ER for LID in patients with Parkinson’s disease and plans to submit an Investigational New Drug Application (IND) to the FDA in the upcoming months[1].

Human Abuse Potential (HAP) Study

A significant recent development is the completion of a human abuse potential (HAP) study for oral nalbuphine. This study demonstrated statistically significant lower "Drug Liking" scores for clinical doses (81mg and 162mg) compared to IV butorphanol, a commonly used opioid. The study results show that nalbuphine has a lower potential for abuse, which is crucial for its regulatory positioning and potential unscheduled status. This data will be included in the 8-factor analysis for future NDA submissions, supporting the drug's safety profile and ease of prescription access[3][4].

Market Analysis

Current Market Status

The global nalbuphine HCL market is expected to grow over the next few years, driven by increasing demand for effective treatments for chronic conditions such as chronic cough, pruritus, and other indications. The market research report forecasts growth from 2025 to 2030, highlighting the potential for nalbuphine ER to capture a significant share of this market[2].

Competitive Landscape

The pharmaceutical market for chronic cough and pruritus treatments is competitive, with several drugs and therapies vying for market share. However, the unique profile of nalbuphine ER, particularly its lower abuse potential and efficacy in treating severe pruritus and chronic cough, positions it favorably in the market. The lack of serious adverse events reported in clinical trials further enhances its competitive edge[1][3].

Regulatory Environment

The regulatory environment is crucial for the success of nalbuphine ER. The positive results from the HAP study strengthen the drug's regulatory position, supporting its potential to remain unscheduled. This status would provide easier prescription access and fewer regulatory restrictions compared to scheduled medications, which is a significant advantage in the market[3][4].

Market Projections

Growth Potential

The global nalbuphine HCL market is projected to grow significantly over the next few years. With the completion of ongoing clinical trials and the potential approval of nalbuphine ER for new indications, the market is expected to expand. The forecast from 2025 to 2030 indicates a strong growth trajectory, driven by increasing demand for effective and safe treatments for chronic conditions[2].

Revenue Projections

The revenue potential for nalbuphine ER is substantial, given its broad range of potential indications. Successful outcomes from the PRISM trial and other ongoing studies could lead to significant revenue growth. The market research report estimates that the global nalbuphine HCL market will generate substantial revenue, with the exact figures dependent on the drug's performance in clinical trials and its subsequent regulatory approvals[2].

Key Takeaways

  • Clinical Trials: Nalbuphine ER is being evaluated in several clinical trials for indications including prurigo nodularis, chronic cough in IPF and RCC, and levodopa-induced dyskinesia in Parkinson’s disease.
  • Human Abuse Potential: The HAP study results show a lower abuse potential for nalbuphine ER, supporting its safety profile and regulatory positioning.
  • Market Analysis: The global nalbuphine HCL market is expected to grow significantly, driven by increasing demand for effective treatments for chronic conditions.
  • Regulatory Environment: Positive HAP study results support the potential for nalbuphine ER to remain unscheduled, providing easier prescription access and fewer regulatory restrictions.
  • Growth Potential: The market is projected to grow substantially over the next few years, driven by the potential approval of nalbuphine ER for new indications.

FAQs

What is nalbuphine ER, and what are its potential indications?

Nalbuphine ER is an extended-release formulation of the mixed opioid agonist-antagonist nalbuphine. It is being investigated for several potential indications, including severe pruritus associated with prurigo nodularis, chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), and levodopa-induced dyskinesia in Parkinson’s disease.

What are the key findings from the human abuse potential (HAP) study of oral nalbuphine?

The HAP study demonstrated statistically significant lower "Drug Liking" scores for clinical doses of oral nalbuphine compared to IV butorphanol, indicating a lower potential for abuse. No serious adverse events were reported, supporting the drug's favorable safety profile[3][4].

What is the current status of the PRISM trial for prurigo nodularis?

The PRISM trial, a Phase 2b/3 clinical trial, is ongoing but has experienced slower-than-anticipated enrollment due to competition from other trials and site start-up delays in Europe. Top-line data are expected in the future[1].

How does the regulatory environment impact the market potential of nalbuphine ER?

The positive results from the HAP study support the potential for nalbuphine ER to remain unscheduled, which would provide easier prescription access and fewer regulatory restrictions compared to scheduled medications. This status is crucial for its market success[3][4].

What are the market projections for nalbuphine HCL?

The global nalbuphine HCL market is projected to grow significantly from 2025 to 2030, driven by increasing demand for effective and safe treatments for chronic conditions. The exact revenue figures will depend on the drug's performance in clinical trials and subsequent regulatory approvals[2].

Sources

  1. Trevi Therapeutics. "Advancement of Nalbuphine ER in Clinical Development for Three Indications." Investor Site - Press Releases.
  2. Market Research Reports. "Global Nalbuphine HCL Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030."
  3. Stock Titan. "Trevi Therapeutics Announces Positive Topline Results from Human Abuse Potential Study of Oral Nalbuphine."
  4. Trevi Therapeutics. "Trevi Therapeutics Announces Positive Topline Results from Human Abuse Potential Study of Oral Nalbuphine." IR.TreviTherapeutics.com.
Last updated: 2025-01-01

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