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.
NCT00271973 ↗	OXY-2: The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models	Completed	Odense University Hospital	Phase 4	2006-02-01	Thirty-two healthy volunteers will be submitted to experimental pain and on the 2 study days receive Oxycodone 20 mg po vs. placebo. Half of the volunteers will be poor metabolizers according to CYP2D6 genotype and half will be extensive metabolizers (EM) and have an enzyme with normal function. The study hypothesis is that PM will experience less pain relief than EM.
NCT00580294 ↗	A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)	Completed	Endo Pharmaceuticals	N/A	2007-11-01	The purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This study will examine if the switching from one pain medication to another can be done over a 24 hour period. Oxymorphone, the drug being studied, is an FDA approved drug for treatment of severe pain.
NCT00580294 ↗	A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)	Completed	Icahn School of Medicine at Mount Sinai	N/A	2007-11-01	The purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This study will examine if the switching from one pain medication to another can be done over a 24 hour period. Oxymorphone, the drug being studied, is an FDA approved drug for treatment of severe pain.

Clinical Trial Conditions for OXYMORPHONE HYDROCHLORIDE

Condition Name

Condition Name for OXYMORPHONE HYDROCHLORIDE
Intervention	Trials
Chronic Pain	9
Pain	9
Post-operative Pain	2
Opioid-use Disorder	2

Condition MeSH

Condition MeSH for OXYMORPHONE HYDROCHLORIDE
Intervention	Trials
Chronic Pain	10
Pain, Postoperative	8
Back Pain	2
Postoperative Nausea and Vomiting	2

Clinical Trial Locations for OXYMORPHONE HYDROCHLORIDE

Trials by Country

Trials by Country for OXYMORPHONE HYDROCHLORIDE
Location	Trials
United States	107
Denmark	2
Canada	1
Taiwan	1
Thailand	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
Terminated	3

Clinical Trial Sponsors for OXYMORPHONE HYDROCHLORIDE

Sponsor Name

Sponsor Name for OXYMORPHONE HYDROCHLORIDE
Sponsor	Trials
Endo Pharmaceuticals	18
Kaohsiung Medical University Chung-Ho Memorial Hospital	2
Sandoz	2

Sponsor Type

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

OxyMORPHONE HYDROCHLORIDE: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 27, 2026

What is the current clinical-trials picture for oxyMORPHONE hydrochloride?
OxyMORPHONE hydrochloride is a long-standing opioid analgesic. As a marketed product class, it primarily appears in three trial formats: (1) post-approval safety and efficacy studies tied to specific formulations and dosing schedules, (2) pharmacokinetic or bioequivalence work for generic and new-manufacturing supply, and (3) limited investigations in pain subpopulations or in mitigation strategies around opioid risk. Public trial volume is typically concentrated around generic/formulation activity rather than new molecular entity development because the active ingredient is mature and off-patent in many jurisdictions.

Clinical trial activity (practical view for investors and R&D planners)
Because the request targets “oxymorphone hydrochloride” broadly rather than a specific branded product or formulation (immediate-release vs extended-release; branded vs generic), the most decision-relevant trial signals are formulation-specific rather than molecule-specific. In practice, the molecule’s clinical footprint is dominated by:

• Bioequivalence and comparative pharmacokinetic studies for generic oxyMORPHONE hydrochloride products (including reformulations, scale-up batches, and manufacturing transfers).
• Label-conformance studies tied to opioid safety monitoring and risk management (studies may be observational or registry-based even when described as “trials” in certain registries).
• Small, pain-focused studies that typically do not reset the competitive landscape unless they create differentiated claims (for example, a new abuse-deterrent mechanism, a novel delivery system, or a distinct dosing strategy).

What matters most for development decisions right now
For a mature opioid active ingredient, the two biggest determinants of trial relevance are:

• Formulation differentiation: extended-release vs immediate-release, and whether the dosage form has abuse-deterrent or tamper-resistance features that can support payer and formulary positioning.
• Regulatory pathway: most additional clinical work is used to support generic approvals, manufacturing changes, or label updates rather than brand-new efficacy paradigms.

How to read the pipeline signal
For oxyMORPHONE hydrochloride, a meaningful “pipeline update” typically looks like one of the following:

• A new entrant with a differentiated dosage form that changes prescribing patterns (for example, abuse-deterrent extended-release).
• A label or safety update that affects opioid stewardship protocols or risk mitigation requirements.
• A manufacturing or formulation change that triggers new bioequivalence trials but can still matter commercially through supply reliability and wholesaler contracts.

Note: A true, date-stamped, trial-by-trial update requires identifying the specific oxyMORPHONE hydrochloride products and their registry entries (for example, by formulation name, sponsor, and NCT/clinical-trial IDs). The request does not constrain to product/formulation or trial registry fields, so a complete, accurate clinical-trials update cannot be produced from the information provided.

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What does the current market look like for oxyMORPHONE hydrochloride?

Market structure
The oxyMORPHONE hydrochloride market is typically characterized by:

• A mix of branded legacy products and multiple generic versions across major markets.
• Heavy payer and pharmacy-channel reliance on opioid stewardship, prior authorization rules, and step therapy in many health systems.
• Demand sensitivity to opioid prescribing trends and state-level opioid policy shifts.
• Competitive pressure from other strong opioids and abuse-deterrent alternatives, especially where formularies tighten opioid access.

Key commercial drivers

1. Formulary access and substitution behavior
   Generic availability drives price competition and interchangeability. Differentiation that can slow substitution usually comes from:

   • extended-release dosing convenience,
   • patient-specific tolerability claims,
   • abuse-deterrent labeling or mechanisms.

2. Opioid utilization and safety environment
   Uptake and retention track national and local prescribing patterns and enforcement intensity around opioid misuse. Where restrictions tighten, volumes shift to agents perceived as safer or more administratively manageable under payer policies.

3. Supply reliability
   For mature opioids, supply interruptions can produce short-term market share swings among available manufacturers, even if long-term demand is stable.

Competitive set (substitution risk)
OxyMORPHONE hydrochloride competes indirectly and sometimes directly with:

• Other Schedule II opioids with broader formulary acceptance depending on payer policy.
• Abuse-deterrent extended-release opioids positioned for restricted patient populations.
• Alternative analgesic classes where opioid-sparing guidelines take effect.

Where price compression typically lands
For mature, off-patent molecules, market prices usually compress after generic entries, with revenue tied more to volume and distribution contracts than to unit pricing.

Note: A complete market analysis with quantified market size, unit volumes, and regional shares requires external datasets (sales, prescriptions, pricing benchmarks, and payer coverage analytics). No such datasets were provided, and a precise projection cannot be produced without them.

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What is the projection for oxyMORPHONE hydrochloride through the next 5 to 10 years?

Base-case projection logic for a mature opioid active ingredient
Absent product re-patenting (which is uncommon for the active ingredient itself), long-horizon projection typically follows these patterns:

• Volume: modest growth or decline driven by opioid prescribing trends, substitution toward other opioids, and patient selection by formulary rules.
• Pricing: continuing pressure from generic competition and channel contracting dynamics.
• Share: winners tend to be manufacturers with stable supply, better payer contracting, and dosage-form advantages.

Scenarios that can move the needle

1. Tightening opioid policy and coverage restrictions
   Can reduce overall utilization and accelerate substitution.

2. Formulation differentiation that improves payer acceptance
   Can protect share in specific patient cohorts (for example, extended-release with abuse-deterrent positioning).

3. Supply shocks
   Create temporary share gains that may or may not stick after normalization.

Note: A credible numeric projection requires baseline market size and forecast drivers grounded in published sales/prescription data. The request does not supply those inputs, and an accurate quantified forecast cannot be produced from general knowledge alone.

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Commercial and R&D implications

If you are planning R&D investment
For oxyMORPHONE hydrochloride, the highest-probability development paths that can produce commercial differentiation are formulation and lifecycle:

• abuse-deterrent or tamper-resistance approaches that translate into payer or guideline acceptance,
• patient-focused dosing or release profile changes that support real-world tolerability differentiation,
• supply-chain reliability improvements coupled with contracting strategy.

If you are evaluating market entry or capacity
The main decision variables are:

• expected ability to secure favorable formulary positions or distribution contracts,
• product reliability and manufacturing quality systems,
• pricing strategy under generic-to-generic competition,
• audit readiness for opioid stewardship and controlled-substance compliance requirements.

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Key Takeaways

• OxyMORPHONE hydrochloride is a mature opioid with clinical trial activity concentrated in formulation and regulatory support formats (bioequivalence and label-conformance-type work), not typically in new mechanism development.
• The market is shaped by generic competition, formulary access, opioid utilization policy, and supply reliability.
• Numeric market size and quantified multi-year forecasts require sales/prescription and payer coverage data that were not provided; a complete projection cannot be produced accurately on the available information.

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FAQs

1. Is oxyMORPHONE hydrochloride still actively studied in clinical trials?
   Yes, but trial activity is typically driven by formulation and regulatory needs, including bioequivalence and label-conformance work.

2. What determines whether a new oxyMORPHONE product wins market share?
   Formulation differentiation (especially extended-release attributes and any abuse-deterrent positioning), supply reliability, and payer or formulary contracting.

3. Why does oxyMORPHONE often face intense pricing pressure?
   The active ingredient is mature and widely generic, making the market sensitive to generic entrants and wholesaler contracting.

4. How do opioid policy changes affect oxyMORPHONE demand?
   Policy tightening can reduce opioid utilization and accelerate substitution to other formulary-favored options.

5. What type of trial results would be most commercially meaningful for oxyMORPHONE?
   Studies that support differentiating claims that change prescribing behavior, formulary placement, or opioid-risk management workflows.

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References (APA)

[1] ClinicalTrials.gov. (n.d.). OxyMORPHONE hydrochloride results. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. (n.d.). Drugs@FDA: Oxymorphone hydrochloride. https://www.accessdata.fda.gov/scripts/cder/daf/
[3] Center for Drug Evaluation and Research, U.S. FDA. (n.d.). Guidance documents and related regulatory information for opioid and abuse-deterrent formulations. https://www.fda.gov/drugs/development-approval-process-drugs/guidances