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.

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
Icahn School of Medicine at Mount Sinai	2
Kaohsiung Medical University Chung-Ho Memorial Hospital	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 Future Projections

Last updated: October 28, 2025

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Introduction

Oxymorphone Hydrochloride, a potent semi-synthetic opioid analgesic, has historically played a significant role in managing severe pain, particularly in postoperative and palliative care settings. As the landscape of pain management evolves amid regulatory scrutiny and societal challenges linked to opioid use, understanding the current clinical trial status, market dynamics, and future outlook for Oxymorphone Hydrochloride becomes crucial for industry stakeholders, healthcare providers, and investors.

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Clinical Trials Update

Current Landscape

Oxymorphone Hydrochloride remains under active clinical investigation primarily for its efficacy, safety profile, and potential abuse-deterrent formulations. According to ClinicalTrials.gov, there are ongoing studies evaluating its application in specialized pain management protocols.

Key Trials and Focus Areas

1. Abuse-Deterrent Formulations

   Recent trials focus on developing formulations that mitigate misuse and diversion. For instance, phase II and III trials are assessing novel delivery systems—such as abuse-deterrent tablets and injectable formulations—to enhance safety profiles.

2. Combination Therapy Studies

   Trials are exploring Oxymorphone Hydrochloride in combination with other agents, such as acetaminophen or NSAIDs, to improve analgesic efficacy while reducing required dosages, thereby potentially lowering abuse and dependency risks.

3. Special Population Studies

   Subpopulation studies target cancer-related pain and opioid-tolerant patients, examining dosing strategies, tolerability, and safety in populations with complex comorbidities.

Regulatory Status and Challenges

Despite promising developments, regulatory agencies such as the FDA maintain stringent oversight due to opioid-related risks. Recent submissions for revised formulations incorporate abuse-deterrence technologies, with some clinical trials showing favorable safety and efficacy outcomes.

Notable Trials and Outcomes

• A Phase III study (NCT04182356) reported that an abuse-deterrent Oxymorphone formulation reduced misuse behaviors without compromising analgesic efficacy over 12 weeks of treatment.

• Ongoing research into transdermal delivery systems aims to provide alternative routes of administration, potentially improving patient compliance and reducing oral abuse potential.

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Market Analysis

Historical Market Context

Oxymorphone Hydrochloride has traditionally been a niche product, given its high potency and associated regulatory restrictions. The global opioid analgesics market was valued at approximately USD 11 billion in 2021 and is projected to grow at a CAGR of around 5.8% through 2028 [1].

Current Market Dynamics

1. Market Segmentation

   • End-User: Hospitals, pain clinics, retail pharmacies.
   • Geographical Distribution: North America accounts for over 70% of sales, driven by established pain management protocols and high opioid consumption.

2. Key Players

   Major pharmaceutical companies such as Endo Pharmaceuticals, Purdue Pharma (now facing legal challenges), and Teva Pharmaceuticals hold existing formulations or licensing rights for Oxymorphone derivatives.

3. Regulatory Constraints and Impact

   Stringent regulations, including scheduling restrictions (e.g., Schedule II in the US), limit distribution and prescribing practices. These constraints dampen market growth potential but are countered by demand in specialized medical settings.

Trend Shifts in Demand

• Increasing emphasis on abuse-resistant formulations catalyzes R&D investments.
• The emergence of multimodal pain management approaches slightly reduces reliance on highly potent opioids like Oxymorphone.

Competitive Landscape

The market sees competition from other opioids such as hydromorphone, oxycodone, and fentanyl, along with non-opioid analgesics like gabapentinoids and NSAIDs.

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Market Projections

Short-term Outlook (Next 3 Years)

• Regulatory pressures intensify, leading to a cautious approach in formulation approvals.
• Limited but steady demand persists for approved abuse-deterrent versions in institutional settings.
• R&D investments in reformulated Oxymorphone and delivery systems could unlock niche market segments.

Medium to Long-term Outlook (3-10 Years)

• Emergence of Abuse-Deterrent and Novel Delivery Systems: FDA and EMA approval of innovative formulations could expand market share.
• Growth in Chronic Pain Management: As alternative therapies are lacked or limited, some clinicians may revert to potent opioids, including Oxymorphone, with appropriate safeguards.
• Regulatory Environment: Potential easing or tightening depending on public health policies, legal frameworks, and societal pressures.

Potential for Market Expansion

• Geographical Diversification: Increasing acceptance and regulation adjustments in Europe and Asia could foster growth.
• Innovative Indications: Use in opioid-tolerant cancer pain or in combination therapies may serve as growth drivers.

Risks and Barriers

• High regulatory hurdles and societal pushback against opioids.
• The opioid epidemic's ongoing impact, influencing prescribing limitations and market sentiments.

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Conclusion & Strategic Implications

While Oxymorphone Hydrochloride faces significant regulatory and societal challenges, ongoing clinical endeavors for safer formulations and innovative delivery methods suggest a cautiously optimistic future. Stakeholders should monitor regulatory developments, prioritize abuse-deterrent technology advancements, and explore diversification into niche therapeutic markets to capitalize on emerging opportunities.

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Key Takeaways

• Clinical Innovation: Current trials focusing on abuse-resistant formulations could rejuvenate Oxymorphone's market viability.
• Market Outlook: Growth is constrained but present in specialized sectors, with potential expansion through regulatory acceptance of newer formulations.
• Regulatory Landscape: Ever-changing policies necessitate active engagement and compliance to unlock market access.
• Investment Considerations: Opportunities exist in R&D and niche markets; however, societal and legal challenges pose significant risks.
• Future Trends: Integration of multimodal analgesia and abuse-deterrence strategies will shape the future of Oxymorphone Hydrochloride.

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FAQs

1. What are the primary challenges facing Oxymorphone Hydrochloride in the current pharmaceutical market?
Regulatory restrictions due to opioid misuse concerns, societal pushback against opioids, and competition from non-opioid analgesics limit its market expansion.

2. Are there any promising new formulations of Oxymorphone in development?
Yes. Several abuse-deterrent formulations and alternative delivery methods, including transdermal systems, are under clinical investigation, showing potential to improve safety profiles.

3. How does the regulatory environment impact clinical trials for Oxymorphone derivatives?
Stringent controls around opioids necessitate rigorous safety and abuse potential assessments, often prolonging trial timelines and increasing costs.

4. What market segments are likely to benefit most from cardiopulmonary indications of Oxymorphone?
Hospitals and pain clinics managing severe or chronic pain in opioid-tolerant patients stand to benefit, especially as abuse-deterrent options become available.

5. How might societal and legal shifts influence the future of Oxymorphone Hydrochloride?
Enhanced regulatory scrutiny could restrict usage, but also drive innovation towards safer formulations, potentially restoring clinical and market confidence.

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References

[1] MarketsandMarkets. "Opioids Market by Type, Application, and Region - Global Forecast to 2028," 2022.