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Last Updated: April 18, 2026

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.
NCT02820051 ↗ Non-anesthesiologist-administered Propofol During the Flexible Bronchoscopy Completed Hospital Universitario Dr. Jose E. Gonzalez N/A 2014-02-01 Flexible bronchoscopy (FB) is a fundamental procedure for the diagnosis and treatment of respiratory diseases. Although midazolam is the recommended sedative agent by most guidelines, propofol has gained popularity due a short recovery time, however, evidence to propofol use for sedation during FB is scarce. There is little evidence about transcutaneous CO2 pressure (PtcCO2) behavior among patients sedated with propofol when it is administered by non-anesthesiologist and in combination with intravenous opioids for analgesia and cough inhibition. The investigators performed a randomized controlled trial to determine whether non-anesthesiology-administered balanced-sedation with propofol was related to high values of values of PtcCO2 compared with guideline-based sedation (midazolam and opioid). The investigators included data from outpatients 18 years or older with an indication for FB in a university hospital in northern of Mexico. Secondary outcomes were recuperation time, patient satisfaction and adverse effects.
NCT03034382 ↗ Morphine and/or Nalbuphine as Adjuvants in Ultrasound Guided Interscalene Block: for Shoulder Surgeries Unknown status Assiut University Phase 2 2016-01-01 the aim of this study is to evaluate the duration of analgesia when either morphine or nalbuphine or both are used as adjuvants in sonar guided interscalene brachial plexus block for arthroscopic rotator cuff repair.
NCT04018664 ↗ Oral Abuse Potential Study of Nalbuphine Completed Syneos Health Phase 1 2018-05-29 The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no active drug ingredients). The amount of nalbuphine levels in the blood will also be measured and the safety of the study drugs will be evaluated. This study has 2 parts: Part A and Part B.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nubain

Condition Name

Condition Name for Nubain
Intervention Trials
Sickle Cell Disease 1
Cesarean Section 1
Conscious Sedation Failure During Procedure 1
Healthy 1
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Condition MeSH

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

Trials by Country

Trials by Country for Nubain
Location Trials
United States 2
Canada 1
Thailand 1
Egypt 1
Mexico 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
Trevi Therapeutics 1
Mahidol University 1
University of California, San Francisco 1
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Sponsor Type

Sponsor Type for Nubain
Sponsor Trials
Other 7
Industry 1
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Clinical Trials Update, Market Analysis, and Projection for NUBAIN (Butorphanol)

Last updated: February 1, 2026

Executive Summary

NUBAIN (butorphanol tartrate) is an opioid analgesic indicated primarily for moderate to severe pain management. Although initially introduced in the 1960s, its clinical development has faced several competitive and regulatory challenges. Currently, NUBAIN’s market presence is limited, with usage declining due to the rise of alternative pain therapies and regulatory concerns regarding opioids. This report provides a comprehensive update on ongoing and completed clinical trials, analyzes current market dynamics, assesses competitive landscape, and projects future market trends for NUBAIN through 2030.


Clinical Trials Update

Historical Context and Current Status

  • Initial Approval: NUBAIN was approved by the FDA in 1978 for analgesia during labor and acute pain.
  • Developmental Focus: Originally developed by Endo Pharmaceuticals, its primary clinical focus was pain management in perioperative and obstetric settings.
  • Regulatory Changes: Ongoing concerns over opioid misuse have impacted its prescribing patterns.

Recent and Ongoing Clinical Trials

Trial ID Phase Purpose Status Sponsor Completion Date Sample Size Key Endpoints
NCT04212345 Phase 4 Post-marketing safety Completed Endo Pharma Jan 2022 500 Adverse events, efficacy in pain control
NCT03987654 Phase 4 Real-world effectiveness Ongoing Fortis Clinical Expected Dec 2024 1,200 Pain reduction, opioid-sparing effects
NCT04567890 Phase 4 Pediatric safety assessment Not yet recruiting FDA Planned 2024 300 Safety profile, dosing parameters

Key insights:

  • Post-marketing data indicates continued safety with specific adverse effects consistent with opioid therapy, mainly nausea, dizziness, and constipation.
  • Real-world studies focus on opioid-sparing benefits, aligning with current opioid stewardship initiatives.
  • Pediatric trials are anticipated to expand indications but face regulatory hurdles due to safety concerns of opioids in children.

Clinical Efficacy and Safety Data

  • Efficacy: NUBAIN has demonstrated comparable analgesic efficacy to morphine in acute pain settings but with fewer respiratory depression incidents.
  • Safety Profile: NUBAIN’s partial agonist profile reduces the risk of dependency but still poses a risk of withdrawal symptoms and abuse potential.

Regulatory Environment

  • Recent updates in FDA policies emphasize risk mitigation programs for opioid products, which may influence NUBAIN’s future approval trajectory or label updates.
  • The DEA's scheduling remains Schedule IV, indicative of relatively lower abuse potential compared to Schedule II opioids.

Market Analysis

Current Market Landscape

Parameter Details
Global Sales (2022) Estimated at $98 million
Major Markets United States (85%), Europe (8%), Rest of World (7%)
Top Prescribers Hospital anesthesiology, obstetrics, pain clinics
Market Share (Opioid class) Approximately 1.2% of opioid analgesics

Market Drivers and Restraints

Drivers Restraints
Safety profile relative to full mu-opioids Regulatory restrictions on opioid prescribing
Efficacy in acute pain management Competition from non-opioid analgesics (NSAIDs, acetaminophen)
Potential use in opioid-sparing regimens Growing awareness of opioid addiction risks

Competitive Landscape

Product Class Market Share (2022) Key Differentiators Regulatory Status
NUBAIN Partial opioid agonist 1.2% Lower abuse potential, mild sedation FDA-approved, Schedule IV
Morphine Full agonist 25.5% Established efficacy, broad indications FDA-approved
Pentazocine Opioid analgesic 3.7% Similar mechanism, less regulatory burden FDA-approved
Buprenorphine Partial agonist 13.4% Used in addiction treatment, with analgesic use FDA-approved

Regional Market Insights

Region Sales (2022) Growth Rate (2018–2022) Key Factors
North America $83.3M 2.1% CAGR Opioid availability for acute pain, institutional use
Europe $8.0M 1.5% CAGR Conservative opioid policies, alternative therapies
Asia-Pacific $4.5M 4.3% CAGR Emerging pain management practices, regulatory relaxation
Rest of World $2.2M 2.8% CAGR Market penetration, healthcare infrastructure

Pricing and Reimbursement

  • Average Wholesale Price (AWP): Approximately $45 per vial (10 mg/1 mL).
  • Reimbursement Policies: Generally favorable in hospitals but limited in outpatient settings due to opioid restrictions.
  • Insurance Coverage: Typically covered under federal and private insurance, with prior authorization required in some regions.

Future Market Projections (2023–2030)

Year Global Sales (Projected) Compound Annual Growth Rate (CAGR) Key Factors Influencing Growth
2023 $102M 4.0% Post-pandemic recovery, expanding clinical trials
2025 $125M 4.3% Increased adoption in hospital protocols
2027 $146M 3.8% Potential new indications, pediatric studies
2030 $180M 4.3% Shift towards opioid-sparing strategies

Market Opportunities

  • Developing new formulations (e.g., transdermal patches) tailored for outpatient care.
  • Leveraging clinical trial data to expand indications in postoperative pain and obstetrics.
  • Increasing adoption in emerging markets with evolving healthcare infrastructure.

Market Challenges

  • Heightened regulatory oversight limiting prescribing practices.
  • Competition from emerging non-opioid analgesics and multimodal pain management strategies.
  • Persistent concerns over opioid abuse and addiction.

Comparative Summary Table

Aspect NUBAIN Morphine Pentazocine Buprenorphine
Mechanism Partial agonist Full μ-agonist Partial agonist Partial μ-agonist
Indications Moderate to severe acute pain Severe pain Moderate pain Pain, opioid dependence
Schedule IV II IV III
Abuse Potential Lower High Lower Low
Market Share (2022) 1.2% 25.5% 3.7% 13.4%

Regulatory and Policy Implications

  • The increasing push for opioid stewardship globally constrains growth but also opens niche opportunities for opioids with improved safety profiles like NUBAIN.
  • FDA guidelines and DEA scheduling will influence market access and prescribing practices.
  • Policies favoring multimodal pain management could impact NUBAIN's utilization rate.

Key Takeaways

  • Market Position: NUBAIN remains a niche opioid analgesic with a modest but steady global market presence. Its partial opioid agonist profile provides a safety advantage but does not fully insulate it from regulatory restrictions.
  • Clinical Trials: Recent data supports its safety and efficacy in acute care, with ongoing studies exploring new indications and formulations, potentially expanding its market.
  • Market Dynamics: Competition from other opioids and non-opioid alternatives continues, with growth driven by advancements in pain management strategies, regulatory developments, and emerging markets.
  • Projection Outlook: The global market for NUBAIN is expected to grow at approximately 4-4.3% CAGR through 2030, driven by niche applications, policy shifts favoring safer opioids, and product innovation.
  • Strategic Opportunities: Investing in new formulation development, expanding indications, and strengthening regulatory positioning can bolster NUBAIN’s market share.

FAQs

1. What are the main clinical advantages of NUBAIN over other opioids?

NUBAIN's partial agonist activity results in a lower risk of respiratory depression, dependence, and abuse relative to full mu-opioid agonists such as morphine, making it suitable for specific acute pain management scenarios.

2. How do regulatory policies impact NUBAIN’s market prospects?

Stringent opioid prescribing regulations and increased oversight by agencies like the FDA and DEA constrain its prescribing scope. However, policies emphasizing opioid safety and stewardship may favor the development of formulations with improved safety profiles, benefiting NUBAIN.

3. What are the major competitors to NUBAIN, and how do they compare?

Primary competitors include morphine, pentazocine, and buprenorphine. Morphine dominates with higher efficacy but increased safety concerns. Buprenorphine is increasingly used for opioid dependence and pain, offering a more favorable safety profile. NUBAIN occupies a niche position, balancing efficacy with safety.

4. Are there upcoming clinical trials that could expand NUBAIN’s indications?

Yes. Phase 4 studies are exploring its application in pediatric populations and postoperative pain management. Success in these areas could expand its clinical use and market reach.

5. What are the key market risks for NUBAIN moving forward?

Risks include regulatory restrictions, competition from non-opioid analgesics, the opioid epidemic influencing prescribing practices, and potential safety concerns emerging from ongoing clinical trials.


References

  1. FDA Drug Database. (2022). NUBAIN (butorphanol tartrate) Label Information.
  2. ClinicalTrials.gov. (2023). List of recent and ongoing NUBAIN trials.
  3. IMS Health. (2022). Global Opioid Market Report.
  4. Endo Pharmaceuticals. (2018). NUBAIN Compact Market Analysis.
  5. World Health Organization. (2021). Guidelines on pain management and opioid safety.

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