CLINICAL TRIALS PROFILE FOR DARVOCET-N 50

All Clinical Trials for DARVOCET-N 50

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00652093 ↗	Lumbar Stenosis Outcomes Research II	Terminated	Endo Pharmaceuticals	Phase 4	2008-03-01	The primary objective of the proposed pilot study is to determine the efficacy of oxymorphone hydrochloride and propoxyphene/acetaminophen combination in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients lumbar spinal stenosis that have clinical symptoms of neurogenic claudication. Neurogenic claudication is defined as movement induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or both legs provoked with walking and standing and relieved by sitting, squatting, or forward flexion posturing. The secondary objective is to examine the functional benefit of oxymorphone hydrochloride and propoxyphene/acetaminophen combination with respect to improvement in duration and distance of walking.
NCT00652093 ↗	Lumbar Stenosis Outcomes Research II	Terminated	University of Rochester	Phase 4	2008-03-01	The primary objective of the proposed pilot study is to determine the efficacy of oxymorphone hydrochloride and propoxyphene/acetaminophen combination in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients lumbar spinal stenosis that have clinical symptoms of neurogenic claudication. Neurogenic claudication is defined as movement induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or both legs provoked with walking and standing and relieved by sitting, squatting, or forward flexion posturing. The secondary objective is to examine the functional benefit of oxymorphone hydrochloride and propoxyphene/acetaminophen combination with respect to improvement in duration and distance of walking.

Clinical Trial Conditions for DARVOCET-N 50

Condition Name

Condition Name for DARVOCET-N 50
Intervention	Trials
Lumbar Spinal Stenosis	1

Condition MeSH

Condition MeSH for DARVOCET-N 50
Intervention	Trials
Spinal Stenosis	1
Constriction, Pathologic	1

Clinical Trial Locations for DARVOCET-N 50

Trials by Country

Trials by Country for DARVOCET-N 50
Location	Trials
United States	1

Trials by US State

Trials by US State for DARVOCET-N 50
Location	Trials
New York	1

Clinical Trial Progress for DARVOCET-N 50

Clinical Trial Phase

Clinical Trial Phase for DARVOCET-N 50
Clinical Trial Phase	Trials
Phase 4	1

Clinical Trial Status

Clinical Trial Status for DARVOCET-N 50
Clinical Trial Phase	Trials
Terminated	1

Clinical Trial Sponsors for DARVOCET-N 50

Sponsor Name

Sponsor Name for DARVOCET-N 50
Sponsor	Trials
Endo Pharmaceuticals	1
University of Rochester	1

Sponsor Type

Sponsor Type for DARVOCET-N 50
Sponsor	Trials
Industry	1
Other	1

Clinical Trials Update, Market Analysis, and Projection for DARVOCET-N 50

Last updated: February 1, 2026

Summary

DARVOCET-N 50 (containing propoxyphene and acetaminophen) was a widely prescribed analgesic until regulatory actions significantly impacted its market presence. This report provides a comprehensive analysis of its clinical trial history, current market status, regulatory landscape, and future market projections. The drug's decline stems from safety concerns, notably cardiotoxicity risks associated with propoxyphene. Despite decreased prescriptions, ongoing discussions about re-evaluation and potential formulations continue, influencing future market dynamics.

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Clinical Trials Update

Historical Context and Initial Clinical Trials

• Approval Timeline: DARVOCET-N 50 received FDA approval in 1957 as an analgesic and antipyretic (NDA approval date: 1957).
• Primary Indications: Management of mild to moderate pain.
• Clinical Trials Conducted: Over the decades, multiple phase I-III trials evaluated efficacy and safety, primarily focusing on analgesic effects and safety profiles.

Post-Marketing Surveillance and Safety-Related Trials

• Cardiotoxicity Concerns: Several observational studies identified increased risk of arrhythmias and overdose fatalities linked to propoxyphene (Reference: FDA 2010 Safety Review).
• FDA Safety Warnings: In 2010, the FDA ordered the withdrawal of DARVOCET-N 50 based on data showing increased mortality risk due to cardiotoxicity and overdose potential.
• Ongoing Trials: As of 2023, no active clinical trials evaluate DARVOCET-N 50 for new indications or reformulations.

Year	Key Clinical Activity	Outcome
1957	FDA approval	Market entry
1970-2000	Multiple efficacy and safety studies	Established analgesic efficacy, mounting safety concerns
2010	FDA withdrawal announcement	Market discontinuation
2015-2023	No new clinical trials; safety review updates	Regulatory status finalized, no current trials

Regulatory Actions

• FDA: Completely withdrew DARVOCET-N 50 from U.S. markets in November 2010 (Ref: FDA Drug Safety Communication, 2010).
• EMA & Other Agencies: Followed with similar restrictions or suspensions based on safety data.

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Market Analysis

Historical Market Overview

Time Period	Sales Volume (Units)	Revenue ($ Millions)	Key Drivers
2000-2009	20-25 million units	$250-$300 million	Prescribed extensively for pain relief
2010 (pre-withdrawal)	Peak before withdrawal	Estimates: ~$350 million	Widespread use, limited alternatives

Market Decline Post-Withdrawal

• Decreased Prescriptions: Post-2010, prescriptions dropped sharply (>90% decline).
• Market Value: Estimated market valuation diminished to near zero by 2015.
• Supply Chain Impact: Manufacturers phased out formulations; generic suppliers exited or reformulated.

Current Market Dynamics

Aspect	Status	Notes
Prescriptions	Nearly ceased in U.S., minimal in niche markets	Limited to research or specialized uses (few)
Competing drugs	Tramadol, acetaminophen combinations, opioids (e.g., hydrocodone)	Safer alternatives have replaced DARVOCET-N 50
Regulatory environment	Strict, with bans in multiple jurisdictions	Ongoing monitoring for similar compounds

Market Projections (2023-2030)

Scenario	Assumptions	Market Outlook	Approximate Market Size
Status Quo	No reintroduction, continued market absence	Near zero, residual niche uses	<$1 million annually
Reevaluation & Reformulation	Potential re-approval with enhanced safety measures	Possible niche analgesic market	$50-$100 million (hypothetical if reintroduced with safeguards)
Emergence of Analogues	Development of safer propoxyphenes or derivatives	Potential substitution drugs	Uncertain, speculative

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Regulatory and Policy Trends

Policy Aspect	Impact	Source/Notes
FDA Drug Safety Communications	Banned DARVOCET-N 50, increased safety alarms	2010, FDA
Prescription Drug Monitoring Programs	Reduced misuse, limited prescribing	State-level programs, CDC guidelines
Reformulation Policies	Incentivize development of safer analgesics	FDA's encouragement for reformulation efforts

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Comparison with Similar Drugs

Drug / Class	Efficacy	Safety Profile	Regulatory Status	Market Situation
Tramadol	Moderate analgesic effect	Lower cardiotoxicity, seizure risk	Approved, widespread use	Dominant alternative, growing market
Hydrocodone Combination	Stronger analgesic effect	Opioid dependency, abuse potential	Under strict regulation	Replacing older alternatives due to regulations
NSAIDs	Variable, some comparable analgesia	GI, renal side effects	Widely used, over-the-counter options	Significant market share

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FAQs

1. Can DARVOCET-N 50 be reintroduced in the future?
   Given its safety profile, regulatory agencies are unlikely to approve DARVOCET-N 50 unless reformulated to mitigate cardiotoxicity risks. Reintroduction would require extensive new clinical trials demonstrating safety.

2. Are there ongoing efforts to develop safer analogues of propoxyphene?
   Currently, there are no publicly announced efforts by pharmaceutical companies to develop direct analogues, largely due to the drug’s safety legacy. However, research into safer analgesic compounds continues.

3. What are the main reasons for DARVOCET-N 50’s market withdrawal?
   The primary driver was evidence of increased risk of cardiac arrhythmias and overdose fatalities linked to propoxyphene, as confirmed by FDA in 2010.

4. What legal liabilities affected the manufacturer post-withdrawal?
   Numerous lawsuits and liability claims arose from overdose deaths and cardiovascular risks, leading to market exit and financial liabilities for the manufacturer.

5. How does DARVOCET-N 50 compare with current pain management options?
   It was less potent than strong opioids but was widely used due to perceived safety. Modern options include NSAIDs, acetaminophen, and opioids like tramadol, which have different safety profiles.

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Key Takeaways

• Regulatory decisions have effectively eliminated DARVOCET-N 50 from the market due to safety concerns.
• Clinical trials history highlights the drug’s efficacy but underscores safety issues, especially cardiac toxicity.
• Market projections indicate minimal activity unless significant reformulation or new safety data emerge.
• Competing therapies like tramadol and NSAIDs have replaced DARVOCET-N 50 universally.
• Future market opportunities hinge on drug reformulation, safety profile improvements, and regulatory approval processes.

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References

[1] FDA Drug Safety Communication. (2010). FDA requests removal of certain prescription and OTC products containing propoxyphene.
[2] U.S. Food and Drug Administration. (2022). Medication Guides and Safety Communications.
[3] MarketWatch. (2010–2023). Pharmaceutical sales data and market analyses.
[4] IMS Health. (2010). Prescription drug trends in analgesics.
[5] European Medicines Agency. (2011). Assessment reports on analgesic safety.