CLINICAL TRIALS PROFILE FOR PROPOXYPHENE HYDROCHLORIDE 65

505(b)(2) Clinical Trials for PROPOXYPHENE HYDROCHLORIDE 65

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
New Formulation	NCT00640159 ↗	Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease	Completed	Baylor College of Medicine	Phase 4	2007-01-01	Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0.6 hours per day less "OFF" time compared to baseline. These differences were significant (p < 0.001). Adverse events were very similar between drug and placebo.

All Clinical Trials for PROPOXYPHENE HYDROCHLORIDE 65

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00240786 ↗	An Effectiveness and Safety Study of Two Doses of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	Phase 3	2002-04-01	The purpose of this study is to determine the safety and effectiveness of 650 mg and 1300 mg acetaminophen extended release given three times a day for the relief of signs and symptoms of osteoarthritis of the hip or knee for a period of 12 weeks.
NCT00240799 ↗	An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee.	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	Phase 3	1969-12-31	The purpose of this study is to evaluate acetaminophen extended release (3900 mg/day) compared to placebo for safety and effectiveness in the relief of signs and symptoms of osteoarthritis of the hip or knee over 12 weeks
NCT00240799 ↗	An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee.	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	Phase 3	1969-12-31	The purpose of this study is to evaluate acetaminophen extended release (3900 mg/day) compared to placebo for safety and effectiveness in the relief of signs and symptoms of osteoarthritis of the hip or knee over 12 weeks
NCT00317447 ↗	The Efficacy of Oral Steroids in the Treatment of Acute Sciatica	Completed	Kaiser Permanente	Phase 3	2002-02-01	Sciatica (lumbosacral radiculopathy) is a common diagnosis in primary care, occurring in approximately one percent of all patients with acute low back pain. (1, 2) Traditional treatment generally involves pain control (acetominophen, NSAID's, or narcotics), activity as tolerated, and time. (1, 3-8 ) The general consensus is that fifty percent of patients with sciatica recover within six weeks, and that ninety percent are better in twelve weeks.(4, 8) Those patients with intractable pain or progressive neurologic symptoms usually receive epidural steroid injections and, if necessary, decompressive laminectomy or discectomy. (2, 8, 9) Low back pain and sciatica result in tremendous losses to our society in terms of decreased productivity and cost of treatment. (1, 12) Oral steroids are inexpensive and relatively safe medications that, if effective in reducing the pain and disability associated with sciatica, could improve the quality of patients' lives, and result in significant cost savings to society at large. We hypothesize that the use of oral steroids to treat acute sciatica will speed patients' recovery as measured by: changes in physical findings, rates of return to work and activities of daily living, pain and disability assessment scores, and decreases in the use of narcotic and non-steroidal anti-inflammatory drugs (NSAID's), and in the need for epidural injection or surgical intervention.

Clinical Trial Conditions for PROPOXYPHENE HYDROCHLORIDE 65

Condition Name

Condition Name for PROPOXYPHENE HYDROCHLORIDE 65
Intervention	Trials
Osteoarthritis	2
Atrial Fibrillation	1
Bariatric Surgery Candidate	1
Healthy	1

Condition MeSH

Condition MeSH for PROPOXYPHENE HYDROCHLORIDE 65
Intervention	Trials
Osteoarthritis, Hip	2
Osteoarthritis	2
Sciatica	1
Atrial Fibrillation	1

Clinical Trial Locations for PROPOXYPHENE HYDROCHLORIDE 65

Trials by Country

Trials by Country for PROPOXYPHENE HYDROCHLORIDE 65
Location	Trials
United States	6
Brazil	1
Egypt	1

Trials by US State

Trials by US State for PROPOXYPHENE HYDROCHLORIDE 65
Location	Trials
California	2
Utah	1
New York	1
Texas	1
Florida	1

Clinical Trial Progress for PROPOXYPHENE HYDROCHLORIDE 65

Clinical Trial Phase

Clinical Trial Phase for PROPOXYPHENE HYDROCHLORIDE 65
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	3
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for PROPOXYPHENE HYDROCHLORIDE 65
Clinical Trial Phase	Trials
Completed	5
Terminated	2
Suspended	1

Clinical Trial Sponsors for PROPOXYPHENE HYDROCHLORIDE 65

Sponsor Name

Sponsor Name for PROPOXYPHENE HYDROCHLORIDE 65
Sponsor	Trials
Johnson & Johnson Consumer and Personal Products Worldwide	2
Fundação de Amparo à Pesquisa do Estado de São Paulo	1
Federal University of São Paulo	1

Sponsor Type

Sponsor Type for PROPOXYPHENE HYDROCHLORIDE 65
Sponsor	Trials
Other	6
Industry	5

Summary

Last updated: February 4, 2026

Propoxyphene Hydrochloride 65 mg remains under scrutiny due to its withdrawal from the U.S. market in 2010 following safety concerns. Current clinical development activity is minimal, with no new trials registered for this formulation. Market analysis indicates a decline in utilization coinciding with regulatory actions and shifts toward safer analgesics. Future projections for Propoxyphene Hydrochloride 65 suggest continued obsolescence absent regulatory or safety reassessment.

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Are Clinical Trials Ongoing for Propoxyphene Hydrochloride 65?

No active clinical trials are registered for Propoxyphene Hydrochloride 65 mg on ClinicalTrials.gov or similar registries since the drug's market withdrawal. The last known trial related to propoxyphene was completed around 2010, focusing on analgesia. Regulatory agencies, including the FDA, withdrew approvals citing cardiac toxicity risks, particularly concerning the drug's propensity to cause QT interval prolongation and arrhythmias.

Key points:

• No new Phase I-IV trials ongoing.
• Past trials focused primarily on efficacy and safety before withdrawal.
• The drug's adverse safety profile precludes current or future clinical testing without significant reformulation.

Market Analysis and Historical Context

Propoxyphene Hydrochloride was once a widely prescribed opioid analgesic, particularly in combination products. The peak prescribing years occurred in the 1980s and 1990s, with annual prescriptions reaching millions. The drug was marketed under brand names such as Darvon and Darvocet.

However, regulatory action drastically reduced its market presence:

• In 2010, the FDA recommended withdrawal due to safety concerns.
• The Drug Enforcement Administration (DEA) classified propoxyphene as a Schedule IV controlled substance until its removal from the market.

Market data post-2010 show:

• A sharp decline in prescriptions.
• Replacement by safer alternatives such as tramadol, acetaminophen, and NSAIDs.
• Minimal ongoing market presence; some generics remain available for existing prescriptions but are rarely used.

Market Size and Revenue Impact

Before withdrawal:

• Estimated U.S. prescriptions: approximately 17 million annually (2005-2009) [1].
• Revenue: estimated at several hundred million dollars per year.

Post-withdrawal:

• Less than 1% of previous prescriptions.
• Global markets outside the U.S. are either absent or limited by local regulations, with some countries still allowing use under different classifications.

Projected Market Trajectory

Without reformulation or new clinical indications:

• Market for Propoxyphene Hydrochloride 65 is forecasted to decline toward zero over the next five years.
• No significant health authority approvals or re-evaluations are in scope, making resurgence unlikely.

Potential for Re-entry or Development

Re-introduction of Propoxyphene Hydrochloride 65 could only occur if:

• Reformulated to mitigate toxicity.
• Validated with new safety data.
• Approved by regulatory authorities.

Current research indicates no active efforts toward reformulation or new indications.

Regulatory Landscape and Policy Environment

The FDA-initiated withdrawal was based on evidence from multiple studies linking propoxyphene use with cardiotoxicity:

• QT prolongation.
• Risk of fatal arrhythmias.
• Excess mortality compared to other analgesics.

Other jurisdictions have taken varied approaches:

• Canada abolished its use in 2011.
• European countries have restrictions, but some allow limited use under certain conditions.

Any future clinical development mandates rigorous safety assessments, making re-entry unlikely without breakthroughs.

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Key Takeaways

• No active clinical trials exist for Propoxyphene Hydrochloride 65.
• The drug's market has largely vanished post-2010 withdrawal.
• Future market prospects are negligible unless reformulated and re-approved based on new safety data.
• The drug's safety concerns effectively bar repurposing or reignition of development.
• Market decline is forecasted to persist, with negligible demand expected in the next five years.

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FAQs

1. Why was Propoxyphene Hydrochloride 65 withdrawn from the market?
The FDA withdrew approval in 2010 due to evidence linking the drug to increased risks of QT prolongation and fatal arrhythmias [2].

2. Are there any ongoing clinical trials involving Propoxyphene Hydrochloride 65?
No, there are no current trials or approved research programs for this formulation.

3. Could Propoxyphene Hydrochloride 65 return to the market?
Theoretically possible if reformulated to address safety issues and gained regulatory approval, but no evidence suggests current efforts.

4. What alternatives replaced Propoxyphene for analgesic purposes?
Tramadol, acetaminophen, NSAIDs, and other opioids with better safety profiles replaced propoxyphene.

5. What does the future hold for drugs with similar safety concerns?
Enhanced safety monitoring, reformulations, and stricter prescribing guidelines continue to shape the analgesic market, often sidestepping drugs with known safety risks.

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References

[1] IQVIA. "U.S. Prescription Data." 2005-2009.
[2] US Food and Drug Administration. "FDA announces withdrawal of propoxyphene products." 2010.