CLINICAL TRIALS PROFILE FOR NABUMETONE

All Clinical Trials for nabumetone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00610610 ↗	Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome	Completed	GlaxoSmithKline	Phase 4	2002-01-01	Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited. We investigated whether a history of depressive and/or anxiety disorders was associated with response to treatment in a double blind, randomized, placebo controlled trial of paroxetine controlled release (CR) in fibromyalgia. Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine CR (dose 12.5-62.5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric Interview (M.I.N.I-plus) was used to ascertain current or past diagnoses of depressive and anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); subjects were excluded if they scored greater than 23 on the BDI. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual Analogue Scale for Pain (VAS) scores and number of tender points.
NCT00610610 ↗	Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome	Completed	Duke University	Phase 4	2002-01-01	Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited. We investigated whether a history of depressive and/or anxiety disorders was associated with response to treatment in a double blind, randomized, placebo controlled trial of paroxetine controlled release (CR) in fibromyalgia. Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine CR (dose 12.5-62.5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric Interview (M.I.N.I-plus) was used to ascertain current or past diagnoses of depressive and anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); subjects were excluded if they scored greater than 23 on the BDI. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual Analogue Scale for Pain (VAS) scores and number of tender points.
NCT00688961 ↗	Effects of Omacor and Aspirin on Platelet Function	Completed	Sanford Research	Early Phase 1	2007-06-01	Omacor (now Lovaza) is a pharmaceutical omega-3 fatty acid product. Omega-3 fatty acids can affect blood clotting by altering the function of the blood platelets. Aspirin can do the same. The purpose of this study is to determine the individual and combined effects of these two agents on platelet function using a whole blood method.

Clinical Trial Conditions for nabumetone

Condition Name

Condition Name for nabumetone
Intervention	Trials
Healthy	5
Osteoarthritis, Knee	1
Atrial Fibrillation	1

Condition MeSH

Condition MeSH for nabumetone
Intervention	Trials
Myofascial Pain Syndromes	1
Fibromyalgia	1
Atrial Fibrillation	1

Clinical Trial Locations for nabumetone

Trials by Country

Trials by Country for nabumetone
Location	Trials
United States	5
India	2
Brazil	1
Denmark	1

Trials by US State

Trials by US State for nabumetone
Location	Trials
North Carolina	3
South Dakota	1
Pennsylvania	1

Clinical Trial Progress for nabumetone

Clinical Trial Phase

Clinical Trial Phase for nabumetone
Clinical Trial Phase	Trials
Phase 4	2
Phase 1	4
N/A	1

Clinical Trial Status

Clinical Trial Status for nabumetone
Clinical Trial Phase	Trials
Completed	8

Clinical Trial Sponsors for nabumetone

Sponsor Name

Sponsor Name for nabumetone
Sponsor	Trials
Actavis Inc.	2
Dr. Reddy's Laboratories Limited	2
The Danish Rheumatism Association	1

Sponsor Type

Sponsor Type for nabumetone
Sponsor	Trials
Other	9
Industry	5

Nabumetone Clinical Trials Update, Market Analysis and Projection

Last updated: April 27, 2026

Nabumetone is an oral nonsteroidal anti-inflammatory drug (NSAID) indicated for osteoarthritis and rheumatoid arthritis. As of the latest available public record, nabumetone’s clinical development is mature and largely centered on maintaining/characterizing existing formulations rather than introducing new proprietary therapeutic regimens. The market outlook is driven by generic penetration, pricing compression, and safety-driven substitution patterns within the NSAID class rather than by novel clinical endpoints.

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What do the latest nabumetone clinical trials show?

Trial activity: late-stage and registration-era pattern

Nabumetone is approved and marketed; new “breakthrough” trials have limited visibility in current registries compared with pipeline NSAIDs under active development. The observable clinical-trial footprint for nabumetone in public registries concentrates on:

• Pharmacokinetics (PK) and bioequivalence for generics and/or formulation changes
• Safety/tolerability in controlled settings, typically short duration
• Comparative tolerability and exposure versus other NSAIDs (limited and fragmented)

This profile is typical of an older, off-patent drug where the dominant incremental evidence comes from generic lifecycle studies and post-approval characterization rather than new efficacy claims.

Efficacy endpoints: stable, established

Across historical development, nabumetone’s efficacy has been anchored to standard NSAID outcomes in:

• Osteoarthritis symptom reduction
• Rheumatoid arthritis symptom reduction
• Global assessments and pain/function scores

Current public trial activity has not reshaped the efficacy story in the way new chemical entities do; it mainly maintains the evidence base for current formulations and dosing.

Safety: ongoing relevance drives study volume indirectly

NSAID risk management continues to shape clinical evidence collection across the class (GI risk, renal effects, cardiovascular considerations). For nabumetone, this tends to show up as:

• Label-consistent safety surveillance in trials of approved products
• Risk mitigation statements and prescriber guidance reflected in the prescribing information rather than new mechanistic interventions

Regulatory status and labeling footprint

Nabumetone is covered by established FDA-approved labeling and generic equivalents, which directly suppresses the need for large, novel pivotal efficacy programs.

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Where does nabumetone sit in the NSAID market?

Drug class dynamics: generic-led, price-compressed

Nabumetone competes in a mature NSAID environment dominated by:

• Broad OTC and prescription NSAIDs (e.g., ibuprofen, naproxen, diclofenac, meloxicam)
• Strong generic penetration
• Switching driven by formulary preferences and safety perception

Generic NSAIDs compress pricing and reduce “market share gravity” for any one molecule unless there is a distinct tolerability or access advantage.

Formulary and access are the key drivers

For older NSAIDs, the biggest market determinants are:

• Insurance formulary inclusion (tier placement)
• Quantity and prior authorization rules (varies by payer)
• Switching behavior among prescribers based on GI tolerance perceptions and patient history
• Pack-size economics and pharmacy reimbursement patterns

Nabumetone’s market survival tends to track these mechanical drivers more closely than novel brand marketing.

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How big is the nabumetone market and what is the realistic demand outlook?

Data limitation constraint

No single authoritative source in the provided dataset supports a precise current-year dollar market size for nabumetone specifically. The appropriate analytic approach for a mature, generic NSAID is to forecast using class-level demand and generic pricing compression logic rather than to claim molecule-specific revenue totals without verified inputs.

Market projection framework for nabumetone

A molecule-level projection in a mature NSAID class follows predictable forces:

Demand side

• Osteoarthritis and rheumatoid arthritis prevalence remains the base demand pool.
• NSAID prescribing continues but shifts toward agents with preferred payer coverage or perceived safety advantages.

Supply and pricing side

• Generic competition drives unit price declines.
• Competitive substitution within the NSAID class shifts volume away from less-preferred molecules unless payer formularies keep them on a favorable tier.

Directionally credible projection (qualitative)

• Units: likely stable to modestly declining over time as prescribers rotate among NSAIDs and as alternative anti-inflammatory strategies gain traction.
• Value (revenue): more likely to decline because generic price erosion typically outpaces unit retention.
• Share: more vulnerable at moments of formulary renegotiation and pharmacy network changes.

This pattern is consistent with off-patent NSAID market mechanics.

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What competitive risks matter for nabumetone?

Key risks

• Formulary substitution: payer-driven switching to preferred generic NSAIDs
• Class risk reallocation: GI or cardiovascular risk perception shifts prescriptions toward alternatives
• Supply and price volatility: multi-source generic competition can cause uneven pricing and rebate dynamics
• Therapeutic migration: long-term inflammation management in arthritis can shift to non-NSAID options where clinically appropriate

Key mitigation dynamics

• Generic reliability: broad availability prevents stock-outs that can trigger durable prescriber switching
• Therapeutic familiarity: clinicians already comfortable with dosing and patient response

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What does the IP and exclusivity landscape imply?

Mature patent state

Nabumetone is an older NSAID and is generally treated as off-patent for commercial strategy purposes. For business planning, that implies:

• No near-term expectation of patent-driven market protection
• ROI for any “new” nabumetone program is constrained unless it targets a reformulation, delivery upgrade, or a narrow new indication with credible trial differentiation

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Nabumetone: clinical evidence map for investment relevance

Evidence types most likely to appear going forward

• Generic bioequivalence / formulation adjustment studies
• Short-duration safety and PK characterization
• Label-consistency updates rather than new pivotal trials

What is unlikely

• Large, registration-grade efficacy trials in osteoarthritis or rheumatoid arthritis absent a new proprietary formulation or a distinct clinical differentiation strategy.

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Key Takeaways

• Nabumetone’s clinical trial footprint is dominated by post-approval lifecycle work (PK/bioequivalence and safety characterization) rather than novel pivotal efficacy programs.
• Market prospects are governed primarily by generic NSAID dynamics, formulary tier placement, and payer switching behavior.
• The credible direction is stable-to-modestly declining volume with more pronounced value pressure from price compression.
• Competitive risk is structural: within-class substitution reduces the molecule’s ability to hold pricing power.

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FAQs

1) Is nabumetone still under active clinical development for new efficacy indications?

Public evidence for large, novel pivotal programs is not prominent relative to generic lifecycle studies; the clinical pattern is consistent with an approved, mature NSAID.

2) What trial types should investors expect for an off-patent NSAID like nabumetone?

Bioequivalence/PK, short-duration safety and tolerability, and formulation-focused studies aligned to regulatory maintenance rather than new endpoints.

3) What drives nabumetone sales most in the near term?

Formulary access and payer-driven substitution within generic NSAIDs, plus pharmacy reimbursement and pack-size economics.

4) How does pricing behavior typically change for mature NSAIDs?

Generic entry and multi-source competition usually compress unit prices over time, often reducing revenue faster than units.

5) What are the biggest market risks for nabumetone?

Losing formulary tier position, switching due to perceived GI or cardiovascular risk tradeoffs, and class-level prescribing migration toward preferred NSAIDs.

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Nabumetone prescribing information / label information (FDA access portal entries). https://www.accessdata.fda.gov/
[2] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov: Nabumetone (search results). https://clinicaltrials.gov/
[3] World Health Organization. (n.d.). ATC classification and NSAID class background (reference data). https://www.who.int/