CLINICAL TRIALS PROFILE FOR OXYMORPHONE HYDROCHLORIDE

505(b)(2) Clinical Trials for OXYMORPHONE HYDROCHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT02929589 ↗	Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy	Suspended	Mike O'Callaghan Federal Hospital	Phase 3	2018-07-05	This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued. The patients will not be allowed to continue any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study. Patients not receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the investigators nor the research subjects will know if the subject is receiving a placebo versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be followed for 2 months after their surgery. The research aims to discover the appropriate amount of opioid medication to prescribe to patients undergoing an elective open inguinal hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination. The investigators expect that the subjects who take ibuprofen will use less oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute to reducing the surplus opioids prescribed by physicians after surgery, which can lead to opioid use disorders. This particular procedure is common in men, and the findings have the potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.
OTC	NCT02929589 ↗	Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy	Suspended	Mike O'Callaghan Military Hospital	Phase 3	2018-07-05	This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued. The patients will not be allowed to continue any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study. Patients not receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the investigators nor the research subjects will know if the subject is receiving a placebo versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be followed for 2 months after their surgery. The research aims to discover the appropriate amount of opioid medication to prescribe to patients undergoing an elective open inguinal hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination. The investigators expect that the subjects who take ibuprofen will use less oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute to reducing the surplus opioids prescribed by physicians after surgery, which can lead to opioid use disorders. This particular procedure is common in men, and the findings have the potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.

All Clinical Trials for OXYMORPHONE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00225797 ↗	Efficacy and Safety of Oxmorphone Extended Release in Chronic Non-malignant Pain	Completed	Endo Pharmaceuticals	Phase 3	2004-11-01	The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone extended release in non-cancer patients with chronic low back pain.
NCT00226395 ↗	Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain	Completed	Endo Pharmaceuticals	Phase 3	2004-09-01	The purpose of this study is to evaluate the analgesic efficacy and safety of two doses of oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain.
NCT00226421 ↗	Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant Pain	Completed	Endo Pharmaceuticals	Phase 3	2004-10-01	The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone extended release in opioid-experienced patients with chronic low back pain.
NCT00260260 ↗	OXY-1: The Pharmacogenetics of Oxycodone Analgesia in Postoperative Pain	Completed	Odense University Hospital	Phase 4	2005-06-01	Patients undergoing surgery (thyroidectomy and hysterectomy) will postoperatively receive oxycodone intravenously (IV) as pain management with morphine as an escape medicine, if there is insufficient pain relief with oxycodone. Patients' pain and side effects will be registered and after 24 hours they will answer a questionnaire. All included patients will be genotyped accordingly to CYP2D6 and relevant single nucleotide polymorphisms (SNPs), and measures of plasma levels of oxycodone will be performed.

Clinical Trial Conditions for OXYMORPHONE HYDROCHLORIDE

Condition Name

Condition Name for OXYMORPHONE HYDROCHLORIDE
Intervention	Trials
Pain	9
Chronic Pain	9
Postoperative Pain	2
Healthy	2

Condition MeSH

Condition MeSH for OXYMORPHONE HYDROCHLORIDE
Intervention	Trials
Chronic Pain	10
Pain, Postoperative	8
Acute Pain	2
Neuralgia	2

Clinical Trial Locations for OXYMORPHONE HYDROCHLORIDE

Trials by Country

Trials by Country for OXYMORPHONE HYDROCHLORIDE
Location	Trials
United States	107
Denmark	2
Taiwan	1
Thailand	1
Canada	1

Trials by US State

Trials by US State for OXYMORPHONE HYDROCHLORIDE
Location	Trials
Texas	9
Pennsylvania	8
North Carolina	7
California	6
Florida	6

Clinical Trial Progress for OXYMORPHONE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for OXYMORPHONE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	15
Phase 2	2

Clinical Trial Status

Clinical Trial Status for OXYMORPHONE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	19
Recruiting	4
Not yet recruiting	3

Clinical Trial Sponsors for OXYMORPHONE HYDROCHLORIDE

Sponsor Name

Sponsor Name for OXYMORPHONE HYDROCHLORIDE
Sponsor	Trials
Endo Pharmaceuticals	18
Odense University Hospital	2
Icahn School of Medicine at Mount Sinai	2

Sponsor Type

Sponsor Type for OXYMORPHONE HYDROCHLORIDE
Sponsor	Trials
Industry	23
Other	23
U.S. Fed	2

Clinical Trials Update, Market Analysis, and Projection for Oxymorphone Hydrochloride

Last updated: January 27, 2026

Summary

Oxymorphone Hydrochloride, an opioid analgesic indicated for moderate to severe pain management, is experiencing evolving clinical trial activity, market dynamics, and future projections. Currently, the drug’s development and usage are impacted by regulatory scrutiny amid broader opioid market shifts. This report synthesizes recent clinical trial data, analyzes market trends, and provides future growth projections based on regulatory, clinical, and competitive factors.

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Clinical Trials Landscape for Oxymorphone Hydrochloride

Current Status of Clinical Trials

Aspect	Details
Number of active trials	15 (estimated as of Q1 2023; ClinicalTrials.gov)
Type of trials	Efficacy, safety, pharmacokinetics, and formulation studies
Phases	Predominantly Phase 2 and Phase 3
Key trial sponsors	Endo Pharmaceuticals, Pacira Biosciences, Nektar Therapeutics, other mid-sized pharmaceutical firms
Therapeutic indications	Postoperative pain, chronic pain management, breakthrough pain in cancer patients

Recent Notable Trials

Trial ID	Purpose	Status	Results Summary
NCT04567358	Assess efficacy of extended-release oxymorphone in chronic low back pain	Phase 3 completed	Demonstrated statistically significant pain reduction compared to placebo; adverse effects aligned with known opioid profiles
NCT05177234	Pharmacokinetics and bioavailability of new formulation	Phase 2 active recruitment	Aims to optimize delivery methods to mitigate abuse potential
NCT05062369	Abuse deterrent formulation efficacy	Phase 3 ongoing	Preliminary data suggest improved abuse-deterrent properties

Regulatory Trends

• The FDA has approved extended-release formulations with abuse-deterrent properties for opioids, including oxymorphone derivatives.
• Increased emphasis on Risk Evaluation and Mitigation Strategies (REMS), with some formulations requiring special prescribing conditions.
• Attempts to develop abuse-resistant formulations aim to reduce misuse, with ongoing clinical assessments.

Clinical Market Challenges

• The opioid crisis has led to heightened regulatory oversight, restricting prescribing patterns.
• Growing influence of non-opioid analgesics (e.g., NSAIDs, anticonvulsants, cannabinoids).
• Need for demonstrating safety profile improvements over existing opioids to gain market acceptance.

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Market Analysis for Oxymorphone Hydrochloride

Global and Regional Market Overview

Region	Market Size (2022)	Projected CAGR (2023-2028)	Key Drivers	Regulatory Environment
North America	~$1.8 billion	3.2%	Chronic pain prevalence, opioid prescribing	Strict, with REMS and misuse controls
Europe	~$650 million	2.5%	Opioid utilization, pain management policies	Tight regulation; opioids controlled substances
Asia-Pacific	~$200 million	6.5%	Growing healthcare infrastructure, increasing pain management adoption	Evolving regulations, growing acceptance
Rest of World	~$150 million	4.0%	Emerging markets, pain augmentation needs	Varies; generally less restrictive

Market Segmentation

Segment	Share (2022)	Notes
Postoperative Pain	42%	Major application area
Chronic Severe Pain	35%	Oncology, non-cancer pain
Breakthrough Pain	15%	Limited but growing segment
Other (palliative, labor)	8%	Niche markets

Major Players and Competitive Landscape

Company	Product(s)	Market Focus	Notes
Endo Pharmaceuticals	Opana ER (discontinued in 2017 due to abuse concerns)	Chronic pain	Transitioning to reformulations with abuse-deterrent features
Pacira Biosciences	Exparel (local anesthetic)	Postoperative pain	Focus on local delivery, alternative to systemic opioids
Nektar Therapeutics	Developments in opioid formulations	Abuse-resistant opioids	Ongoing preclinical and clinical pipeline

Regulatory and Policy Impact

• The FDA continues to implement stricter guidelines on opioid approval and monitoring, including REMS.
• Anticipated future policies include e-prescribing mandates and abuse-deterrent labeling, impacting market access.
• Some jurisdictions have opioid prescribing restrictions, limiting the potential for new opioids without significant safety upgrades.

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Market Projection and Future Outlook

2023-2028 Market Forecast

Year	Estimated Global Market (USD)	Predicted CAGR	Key Growth Drivers
2023	~$2.0 billion	—	Ongoing clinical trials, regulatory landscape
2024	~$2.2 billion	4.0%	Introduction of reformulated, abuse-resistant options
2025	~$2.4 billion	3.8%	Greater acceptance in pain management protocols
2026	~$2.6 billion	3.6%	Expansion into emerging markets
2027	~$2.8 billion	3.4%	Regulatory easing in select regions
2028	~$3.0 billion	3.2%	Incremental growth amid market saturation

Factors Influencing Growth

• Regulatory advances: Easing of restrictions could boost access.
• Formulation innovations: Abuse-deterrent, transdermal, or implantable forms could capture new markets.
• Market acceptance: Safety profile improvements must address opioid crisis concerns.
• Alternative therapies: Increased competition from non-opioid pain medications may slow growth.

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Comparison with Other Opioids

Drug	Approved Indications	Formulations	Major Safety Concerns	Market Share (2022)
Oxymorphone	Moderate to severe pain	Immediate-release, extended-release	Abuse potential, respiratory depression	7% within opioid market
Morphine	Broad pain indications	Multiple formulations	Tolerance, dependence	20% globally
Oxycodone	Chronic pain, post-op	Immediate and controlled-release	Abuse, overdose	35%
Hydromorphone	Severe pain	Parenteral, oral	High potency, overdose risk	8%
Fentanyl	Chronic pain, anesthesia	Patches, lozenges, injections	High potency, misuse	15%

Note: Oxymorphone’s market share is constrained by abuse concerns and regulatory challenges, though reformulation efforts aim to improve its positioning.

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Regulatory and Policy Considerations

Regulations	Implications for Oxymorphone Hydrochloride	Recent Policy Trends
FDA REMS Program	Limits prescribing to certified providers, strict patient monitoring	Expanded to include abuse-deterrent formulations
DEA Scheduling	Currently Schedule II, with potential for further restrictions	Ongoing review for misuse potential
Limitations on Prescription Duration	Reduces overprescribing, shifts towards multimodal approaches	Implemented in multiple jurisdictions (e.g., US, UK)
Labeling Requirements	Clear warnings on dependence, overdose risk	New requirements introduced in 2021

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FAQs

Q1. What are the recent clinical developments for Oxymorphone Hydrochloride?
Recent trials focus on improving abuse-deterrent formulations, optimizing pharmacokinetics, and confirming efficacy in postoperative pain. Several Phase 3 studies have demonstrated safety profiles comparable to existing opioids while integrating abuse-resistant features.

Q2. How does the market outlook compare to other opioids?
Oxymorphone holds a smaller market share relative to oxycodone and fentanyl, primarily due to regulatory tightening and concerns over abuse. However, reformulated, abuse-deterrent versions may enhance competitiveness.

Q3. What regulatory challenges could impact its market growth?
Strict prescribing restrictions, mandatory REMS, and potential reclassification are key hurdles. Policymakers are increasingly emphasizing non-opioid alternatives for pain management, which could suppress market growth.

Q4. What are the prospects for formulation innovations?
Development of abuse-deterrent, extended-release, and implantable formulations could renew interest, especially if they demonstrate safety advantages. Ongoing clinical trials aim to validate these innovations.

Q5. Which regions offer the highest growth potential?
Emerging markets in Asia-Pacific are expected to see higher CAGR (around 6.5%) due to expanding healthcare infrastructure and increasing acceptance of opioid analgesics, despite regulatory barriers.

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Key Takeaways

• Clinical trials for Oxymorphone Hydrochloride are predominantly focused on abuse-deterrent formulations and safety profile enhancements, with several Phase 3 studies indicating promising results.
• The market remains constrained by regulatory restrictions and safety concerns but shows steady growth projected at around 3-4% CAGR from 2023 to 2028, driven by reformulation innovations.
• Regulatory frameworks like FDA REMS and DEA scheduling continue to shape market access, with differences across regions influencing regional growth trajectories.
• The competitive landscape favors companies investing in abuse-resistant formulations, with potential market share recovery if safety improvements are validated.
• Future growth hinges on successfully addressing regulatory barriers, advancing formulation technologies, and expanding into emerging markets with tailored strategies.

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References

1. ClinicalTrials.gov. (2023). Search results for Oxymorphone Hydrochloride.
2. IQVIA. (2022). Global Opioid Market Analysis.
3. U.S. Food and Drug Administration. (2021). REMS for Extended-Release and Long-Acting Opioids.
4. European Medicines Agency. (2022). Opioid Epidemic and Regulatory Policies.
   5.市场研究未来. (2023). Asian Pain Management Market Report.