CLINICAL TRIALS PROFILE FOR FLURBIPROFEN

All Clinical Trials for Flurbiprofen

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001724 ↗	Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1997-11-01	This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain. Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be eligible for this study. Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery, they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At the time of surgery, patients will also be given flurbiprofen or a placebo formulation (look-alike substance with no active ingredient) directly into the extraction site and a capsule that also may contain flurbiprofen or placebo. One in seven patients will receive only placebo. All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects. Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever. A small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1, 2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of 33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative; the 24- and 48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.
NCT00045123 ↗	R-Flurbiprofen in Treating Patients With Localized Prostate Cancer at Risk of Recurrence	Unknown status	Myrexis Inc.	Phase 2	2002-02-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. R-flurbiprofen may be effective in delaying the recurrence of localized prostate cancer. PURPOSE: Randomized phase II trial to study the effectiveness of R-flurbiprofen in treating patients who have localized prostate cancer at risk of recurrence following radiation therapy and/or prostatectomy.
NCT00088686 ↗	Capsaicin to Control Pain Following Third Molar Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	2004-07-01	Capsaicin to Control Pain Following Third Molar Extraction Summary: This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. If capsaicin alleviates pain in dental surgery, it may have potential for use in many types of surgery and painful illnesses. Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants undergo the following procedures in three visits: Visit 1 Patients have touch (sensory) testing inside the mouth using three methods: 1) applying a temperature probe onto the gums and having the patient rate how warm it is; 2) applying a gentle stroke across the gums with the bristles of a small paint brush and having the patient say whether or not it feels painful; and 3) applying a light touch to the gums with a small needle and having the patient rate the pain intensity following the touch. Following touch testing, the patient's mouth is numbed with an anesthetic and a small piece of gum tissue next to the lower wisdom tooth is removed (biopsied). Then, a small amount of either capsaicin or placebo (saline, or salt water) is injected next to the wisdom tooth. Visit 2 Following repeat the touch testing, patients are sedated with an injection of midazolam. They then have another biopsy under local anesthesia on the same side of the mouth as the first biopsy. Their mouth is again numbed with an anesthetic, and they are given either a pain-relieving medicine called Toradol or a placebo injected into the arm. One lower wisdom tooth is then extracted. After the extraction, pain ratings are recorded every 20 minutes for up to 6 hours. During this time, patients are monitored for vital signs, numbness, pain, and side effects. Patients who request pain-relief medication are given acetaminophen and codeine. At the end of the study, they are discharged from the clinic and given acetaminophen and codeine to take at home, as instructed. They are provided a pain diary to record pain ratings and any adverse reactions that might occur until the last visit. Visit 3 Patients return for a follow-up evaluation 48 hours after discharge from the clinic. At the end of the evaluation, they are discharged home with flurbiprofen for pain relief. Remaining wisdom teeth are removed "off-study" no sooner than 1 week following the first visit.
NCT00425451 ↗	The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis	Completed	Dexcel Pharma Technologies Ltd.	Phase 2	2008-08-01	The purpose of this study is to determine the effect of the placement of a PerioChip Plus (flurbiprofen/chlorhexidine - FBP/CHX) formulation versus PerioChip (chlorhexidine) formulation versus Flurbiprofen Chip formulation versus Placebo Chip formulation on probing pocket depth (PPD)
NCT00615212 ↗	Effect of GSK376501 on CYP450 Activity in Healthy Adult Subjects	Completed	GlaxoSmithKline	Phase 1	2008-01-02	This study is meant to assess potential inhibitory effects of GSK376501 on CYP450 isoenzymes 3A4, 2C8, 2C9. subjects will receive probe compounds and systemic levels of these substrates will be compared pre and post dosing of GSK376501.
NCT00725218 ↗	Flurbiprofen Axetil for Uterine Contraction Pain	Completed	Nanjing Medical University	Phase 4	2008-05-01	Uterine contraction pain is a common problem after abortion. Optimal analgesic for such suffering is still needed to be guaranteed. Flurbiprofen Axetil is a target-distributable non-steroidal anti-inflammatory drug (NSAID) functioning via block the synthesis of prostaglandin E (PGE). The investigators hypothesized that Flurbiprofen Axetil could suppress the uterine contraction pain after abortion effectively.

Clinical Trial Conditions for Flurbiprofen

Condition Name

Condition Name for Flurbiprofen
Intervention	Trials
Pain	8
Healthy	8
Healthy Volunteers	8
Surgery	4

Condition MeSH

Condition MeSH for Flurbiprofen
Intervention	Trials
Pain, Postoperative	6
HIV Infections	3
Low Back Pain	3
Arthritis, Rheumatoid	3

Clinical Trial Locations for Flurbiprofen

Trials by Country

Trials by Country for Flurbiprofen
Location	Trials
United States	54
China	22
Australia	8
Switzerland	7
Germany	4

Trials by US State

Trials by US State for Flurbiprofen
Location	Trials
Texas	7
New York	4
Maryland	4
Nevada	2
Florida	2

Clinical Trial Progress for Flurbiprofen

Clinical Trial Phase

Clinical Trial Phase for Flurbiprofen
Clinical Trial Phase	Trials
PHASE4	3
PHASE1	6
Phase 4	12

Clinical Trial Status

Clinical Trial Status for Flurbiprofen
Clinical Trial Phase	Trials
Completed	47
Not yet recruiting	9
Recruiting	8

Clinical Trial Sponsors for Flurbiprofen

Sponsor Name

Sponsor Name for Flurbiprofen
Sponsor	Trials
Bristol-Myers Squibb	9
Reckitt Benckiser LLC	4
Beijing Tiantan Hospital	3

Sponsor Type

Sponsor Type for Flurbiprofen
Sponsor	Trials
Other	54
Industry	39
NIH	2

Flurbiprofen Market Analysis and Financial Projection

Last updated: April 28, 2026

Flurbiprofen: Clinical Trials Update, Market Analysis, and Projection

What does the current clinical-trials landscape show for flurbiprofen?

Flurbiprofen is a marketed NSAID with multiple approved uses across regions, but the modern clinical-trials signal is largely “life-cycle” and formulation-focused rather than broad Phase 3 development typical of novel drugs. Across public registries, ongoing activity clusters in:

• Topical/ophthalmic and local-delivery indications (including pain and inflammation around ocular procedures)
• New formulations (e.g., controlled-release or improved penetration)
• Bioequivalence and bridging studies tied to manufacturing changes or regional approvals

Key implication for investors and R&D planners: pipeline effort is concentrated in incremental programs and regulatory/clinical bridging rather than new systemic-drug MOA expansion. That profile usually correlates with mid/low single-digit incremental revenue uplift in near-term markets unless a new indication or a differentiated delivery platform achieves distinct payer differentiation.

Where is flurbiprofen used and why that matters for market sizing?

Flurbiprofen is widely used as:

• Oral NSAID for pain and inflammation (modelled as prescription and OTC in multiple jurisdictions depending on local status)
• Ophthalmic use in some regions (pain and inflammation associated with ophthalmic surgery and related indications)

The addressable market is driven by:

• Baseline NSAID demand for musculoskeletal pain
• Procedure volumes for ophthalmic indications where flurbiprofen is part of standard regimens
• Share shifts among branded and generic NSAIDs, where flurbiprofen competes on price and formulation

Because flurbiprofen is already established, most “market growth” comes from:

• Expansion of generics and local manufacturing capacity
• Replacement of older NSAIDs in certain protocols
• Uptake where ophthalmic formulations are used and reimbursed

What is the market structure for flurbiprofen?

The flurbiprofen market structure is typical of mature NSAIDs:

• Dominant generic penetration
• Brand persistence in specific delivery forms where ocular or specialized formulations maintain tighter product differentiation
• Competitive intensity from other NSAIDs (ibuprofen, naproxen, diclofenac derivatives, ketorolac in ophthalmics) and combination products

Commercial consequence: pricing pressure is structurally high, so revenue growth is usually volume-led and dependent on maintaining formulary position and competitive pricing.

What is the likely near-term clinical and regulatory pathway?

For flurbiprofen, the practical near-term development path most often looks like:

• BE/bridging studies for reformulation, manufacturing scale-up, or regional product entry
• Small clinical efficacy/safety studies for local delivery variants
• Protocol additions for procedural indications (especially ophthalmic)

This pathway reduces scientific risk but also limits upside. In mature NSAID classes, major upside usually requires:

• A new delivery platform with payer-recognized differentiation
• A new, clearly reimbursed indication with guideline inclusion

How does the competitive set shape flurbiprofen’s revenue prospects?

Flurbiprofen’s competitive set includes:

• Oral NSAIDs (ibuprofen, naproxen, diclofenac and derivatives)
• Topical NSAIDs (where applicable)
• Ophthalmic NSAIDs (notably for perioperative inflammation and pain)

Competitive leverage depends on:

• Formulary inclusion and protocol inertia
• Tender and procurement pricing for generics
• Patient adherence and tolerability relative to alternatives
• Substitution dynamics when patents and brand exclusivity end

Clinical-trials update summary

Across the clinical-trials landscape, flurbiprofen activity remains consistent with a mature drug:

• Studies skew toward local delivery, formulations, and regulatory bridging
• There is no dominant evidence of broad, late-stage “renewal” development that would materially change the systemic NSAID category outlook

Actionable translation: flurbiprofen’s clinical and regulatory workstream is best treated as a product-lifecycle business (formulation + access + competition) rather than a transformational pipeline.

---

Market Analysis and Projection for Flurbiprofen

How should flurbiprofen’s market be projected?

A defensible projection framework for flurbiprofen assumes:

1. Mature-drug volume stability with modest growth driven by population and healthcare utilization
2. Price erosion driven by generics and class competition
3. Potential offset from ophthalmic/procedural uptake where flurbiprofen has formulary position
4. Incremental uplift from new formulations or improved convenience (if regulatory approval and reimbursement align)

What is the baseline growth logic for mature NSAIDs?

For mature NSAIDs:

• Unit volumes often track slowly with growth in treated patients and procedures
• Average selling price typically declines as generic share rises
• Net revenue growth tends to be low unless an exclusive or differentiated segment expands (e.g., ophthalmic niche product with stronger differentiation)

Market projection (scenario-based)

Because public filings for flurbiprofen often lack consistent, consolidated commercial disclosure, projection should be expressed as scenario ranges using category mechanics (volume growth, price erosion). The three scenarios below reflect standard mature NSAID patterns.

Revenue outlook scenarios (global, directional)

Scenario	Assumptions	Likely outcome for net revenue
Bear	Continued price pressure, limited uptake in specialized delivery forms	Low growth or flat revenue, margin compression
Base	Moderate volume growth, ongoing share but continued generic erosion	Low single-digit revenue growth with stable share
Bull	Sustained ophthalmic/procedural positioning gains and successful formulation-led differentiation	Mid single-digit growth potential with partial pricing stabilization

Base case is most consistent with the clinical-trials profile: incremental development, regulatory bridging, and localized delivery studies rather than major new indication wins.

---

Key Commercial Drivers

What drives flurbiprofen demand and retention in formularies?

1. Cost-effectiveness within NSAID class
2. Safety/tolerability profile as used in local label instructions
3. Formulation fit (oral for pain/inflammation, ophthalmic where perioperative use is standard)
4. Switching costs in protocols (especially ophthalmic post-surgery regimens)
5. Supply reliability and tender pricing (generic dominance)

Where does upside realistically come from?

• Ophthalmic niche consolidation if flurbiprofen is positioned as a protocol staple for specific procedure types
• Formulation improvements that support better dosing convenience or reduced adverse effects, leading to stronger payer acceptance
• Geographic expansion where regulatory acceptance lags established brands, enabling generic-led growth

---

Key Takeaways

• Flurbiprofen’s clinical-trials footprint is consistent with life-cycle development, centered on formulations, local delivery, and bridging/regulatory studies, not broad late-stage indication expansion.
• The commercial outlook is typical of mature NSAIDs: generics and price erosion cap revenue growth, while volume stability and niche procedural uptake provide modest upside.
• Near-term projections should be built on scenario logic: bear (flat/margin pressure), base (low single-digit growth), bull (procedural/formulation-led mid single-digit potential).

---

FAQs

1) Is flurbiprofen still seeing meaningful late-stage development?

The observed development pattern aligns with a mature drug lifecycle: clinical work is predominantly incremental (formulation/local delivery/bridging) rather than a dominant late-stage Phase 3 expansion.

2) What parts of the market are most important for future growth?

Growth is most sensitive to specialized delivery segments (notably ophthalmic/procedural use where flurbiprofen has established protocol roles) and to regions where uptake is still expanding.

3) What is the main threat to flurbiprofen revenue?

The main threat is NSAID class price compression, driven by generic competition and procurement pressure.

4) What is the main pathway to maintain competitiveness?

Manufacturers typically compete through product access, formulation differentiation where allowable, and pricing supported by manufacturing scale.

5) How should investors benchmark flurbiprofen against peer NSAIDs?

Benchmark using formulary access in target delivery segments, procurement pricing trends, and relative share in procedure-linked indications rather than expecting transformative clinical differentiation.

---

References

[1] ClinicalTrials.gov. “Flurbiprofen” (search results for interventional studies). U.S. National Library of Medicine.
[2] European Medicines Agency (EMA). EPAR and product information database for flurbiprofen-containing products.
[3] FDA. Drug Labeling and Orange Book information for flurbiprofen products (where applicable).