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
Healthy Volunteers	8
Pain	8
Healthy	8
Postoperative Pain	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
GlaxoSmithKline	3

Sponsor Type

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

Flurbiprofen clinical trials update, market analysis and launch projections (2026–2035)

Last updated: July 28, 2026

Executive summary

• Flurbiprofen is a first-generation NSAID with oral and topical approvals, plus ongoing development activity focused on formulation and delivery improvements rather than new molecular entities.
• The commercial picture is dominated by established generics and low-margin competitive pricing across major markets, with demand tied to seasonal acute indications (minor pain, inflammatory conditions) and procedure-driven use in ophthalmology where flurbiprofen is a standard option.
• For new entrants, the most practical value path is differentiation through safer dosing, improved ocular delivery, or combination products that can clear formulation/IP and clinical endpoints that support label expansion. Pure “new generic” economics are constrained by entrenched competition.

Note: A complete, accurate clinical-trials update with sponsor-by-sponsor status and a numbered projection model requires trial registry and regulatory transaction data. No such source material is present in the prompt.

What is the current clinical trial landscape for flurbiprofen (NCT status, phases, indications)?

Featured snippet answer: Current flurbiprofen development activity is largely formulation- and delivery-oriented, with fewer late-stage trials for new flurbiprofen therapeutic areas than for newer NSAID subclasses.

Which indications show trial activity for flurbiprofen?

• Acute pain and musculoskeletal inflammation (oral/topical formulations)
• Ocular inflammation related to cataract and perioperative settings (topical/ocular delivery systems)
• Local pain models that favor improved penetration and reduced systemic exposure (patch, gel, transdermal variants, or ophthalmic formulations)

What trial endpoints are typically used for flurbiprofen studies?

• Pain intensity change from baseline (oral/topical analgesic models)
• Inflammation markers or symptom scores in arthritis and soft-tissue inflammation cohorts
• For ophthalmic flurbiprofen, reduction in postoperative anterior chamber inflammation measures and endothelial cell safety metrics

How do flurbiprofen trials differ from trials for other NSAIDs?

• Flurbiprofen studies often emphasize local delivery performance, tolerability, and drug exposure at target tissue rather than novel efficacy biology.

Which companies are developing flurbiprofen formulations and delivery systems?

Featured snippet answer: Development is typically spread across generic and branded formulation players, with ocular specialists and localized-delivery formulators active in ophthalmic positioning.

What types of sponsors run flurbiprofen programs?

• Generic drug developers improving oral solid dose stability or bioavailability
• Ophthalmic formulation companies seeking better penetration and reduced dosing frequency
• Contract research groups executing comparative bioequivalence plus tolerability studies for reformulations

What does “clinical development” usually mean for flurbiprofen?

• Bioequivalence bridging studies
• Formulation proof-of-concept (local tolerability, drug release, ocular residence time proxies)
• Label-enabling trials for specific dosing regimens or device/vehicle changes

When do flurbiprofen patents expire and what does that mean for trial strategy?

Featured snippet answer: Patent coverage around flurbiprofen is largely historical, with reformulation and composition/optimization patents driving incremental protection.

How patent expiry affects enrollment and study design

• Post-expiry strategies focus on what regulators require: bioequivalence and clinical bridging.
• Sponsors use smaller clinical studies when a new formulation can be justified via pharmacokinetic comparability and acceptable safety.

Where formulation patents tend to cluster

• Ophthalmic vehicles, suspensions, or solubilization systems
• Extended-release or controlled-release designs (topical/oral hybrids)
• Salt forms, polymorphs, or particle size distributions (where applicable)

What is the Orange Book status of flurbiprofen across major products?

Featured snippet answer: Flurbiprofen is widely available as AB-rated generics, with the reference listed drug generally long off exclusivity.

How to interpret Orange Book relevance

• Orange Book entries map to generic competition intensity.
• For business planning, the number and readiness of ANDA approvals (and any stays) determine launch timing more than the original RLD.

No Orange Book listing data is provided in the prompt, so a product-by-product status table cannot be produced.

How strong is the patent estate for flurbiprofen (composition, formulation, method-of-use)?

Featured snippet answer: Strength is usually low for new entrants at the molecule level, higher only for specific formulation/process improvements that have their own filing and regulatory exclusivity.

Typical flurbiprofen IP components

• Composition of matter for particular formulation systems
• Method-of-use for specific dosing schedules or indications
• Manufacturing process claims linked to particle control or sterilized ocular preparation

What does weak IP imply for litigation and licensing?

• Few high-value primary listings.
• Settlements more likely involve reformulation or specific dosing claims rather than broad molecule exclusivity.

What is the market size and demand driver for flurbiprofen by indication?

Featured snippet answer: Flurbiprofen demand tracks acute pain episodes and chronic inflammatory burden in pockets where topical or oral use persists, plus procedure-driven ophthalmic use.

Demand drivers

• Seasonal variability in minor pain and musculoskeletal conditions
• Dermatologic and orthopedic preference for topical NSAIDs in certain patient populations
• Ophthalmic perioperative protocols (where topical NSAIDs are routine)

Where utilization is highest

• Oral generic NSAIDs in mature markets with broad reimbursement
• Topical formulations where local tolerability improves adherence
• Ophthalmic settings where dosing schedules are standardized

No market-share, unit, or revenue dataset is included in the prompt, so numerical market sizing cannot be produced.

How does flurbiprofen revenue performance compare with other topical NSAIDs?

Featured snippet answer: Flurbiprofen competes in a crowded topical NSAID field, where pricing pressure and retail formularies dominate performance.

Peer comparison set (strategic)

• Diclofenac topical
• Ketoprofen topical
• Ibuprofen topical formulations
• Other NSAIDs with stronger brand-to-generic conversion economics

What drives share movement

• Payer formulary placement
• Evidence for tolerability and local efficacy
• Dosing frequency convenience and product handling characteristics
• Wholesale acquisition cost and rebate structures

What is the competitive landscape for flurbiprofen generics and authorized brands?

Featured snippet answer: Competitive pressure is high, and differentiation is primarily vehicle and packaging, not pharmacology.

Common competitive scenarios

• Multiple ANDA products launched with near-identical dosage form and strength
• Payer-driven substitution toward the lowest net price
• Brand survival driven by legacy trust, local supply stability, and distribution contracts

When do new flurbiprofen generic launches become feasible (ANDAs, 505(b)(2))?

Featured snippet answer: Launch feasibility is constrained by product-specific regulatory barriers rather than flurbiprofen’s molecule-level exclusivity.

Generic entry risks that matter in practice

• Patent stays tied to listed patents in the Orange Book
• Formulation-specific bioequivalence challenges (especially if reformulated)
• Device- or vehicle-related regulatory requirements for topical/ocular products

What timing affects the most

• ANDA acceptance and completeness reviews
• Patent litigation/settlement timing
• Manufacturing readiness and stability testing windows

No Orange Book and litigation timeline data is provided in the prompt, so a launch calendar cannot be constructed.

What clinical trial signals would justify investment in a new flurbiprofen program?

Featured snippet answer: Enrolling only for standard analgesic endpoints rarely changes market structure; the bar is higher for differentiation.

Investment-grade clinical signals

• Improved local exposure with lower systemic exposure proxy endpoints (PK/PD)
• Demonstrated reduced dosing frequency with equivalent pain or inflammation control
• Higher tolerability leading to better adherence in real-world dosing regimens
• Clear label expansion that unlocks a new reimbursement category

Market projection for flurbiprofen (2026–2035): scenarios and drivers

Featured snippet answer: Expect stable-to-declining unit pricing in mature markets, with incremental volume growth only where supply expands or formulations change to improve adherence.

Base case (most likely)

• Stable demand with continued net price erosion
• Margins pressured by generic substitution and competitive rebate intensity
• Growth limited to share shifts across retail and institutional formularies

Bull case

• A successfully differentiated formulation with dosing convenience improves adherence
• Ocular/perioperative positioning broadens within protocol-driven settings
• Supply chain reliability supports contracted volumes

Bear case

• Additional generic entrants increase price competition
• Regulatory delays in new formulation programs
• Continued preference shift toward alternative NSAID classes with better clinical positioning

No numeric inputs, history, or regional market datasets are supplied in the prompt; therefore, a quantified projection curve cannot be produced.

Key Takeaways

• Flurbiprofen development remains formulation- and delivery-centric, with fewer opportunities for step-change therapeutics.
• Market economics are shaped by generic competition and rebate-driven pricing, leaving limited upside for standard generics.
• The investable path is differentiation via ocular/topical delivery, tolerability improvements, dosing convenience, or label expansions supported by clinical bridging.

FAQs

1. How do formulation changes affect flurbiprofen bioequivalence and regulatory approval strategy?
2. What are the most common reasons flurbiprofen ANDAs face delays (CMC, stability, or bridging requirements)?
3. Which ocular inflammation indications create the most consistent demand for topical NSAIDs like flurbiprofen?
4. How does payer formulary design typically determine which topical NSAID brands survive to the next contracting cycle?
5. What clinical endpoints best support switching from flurbiprofen to competing NSAIDs in perioperative protocols?

References

1. No sources were provided in the prompt.