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)

Clinical Trial Conditions for FLURBIPROFEN

Condition Name

Condition Name for FLURBIPROFEN
Intervention	Trials
Pain	8
Healthy Volunteers	8
Healthy	7
Postoperative Pain	4

Condition MeSH

Condition MeSH for FLURBIPROFEN
Intervention	Trials
Pain, Postoperative	5
Arthritis	3
Pharyngitis	3
HIV Infections	3

Clinical Trial Locations for FLURBIPROFEN

Trials by Country

Trials by Country for FLURBIPROFEN
Location	Trials
United States	54
China	20
Australia	8
Switzerland	7
Germany	4

Trials by US State

Trials by US State for FLURBIPROFEN
Location	Trials
Texas	7
Maryland	4
New York	4
Connecticut	2
Wisconsin	2

Clinical Trial Progress for FLURBIPROFEN

Clinical Trial Phase

Clinical Trial Phase for FLURBIPROFEN
Clinical Trial Phase	Trials
PHASE4	2
PHASE1	4
Phase 4	12

Clinical Trial Status

Clinical Trial Status for FLURBIPROFEN
Clinical Trial Phase	Trials
Completed	46
Not yet recruiting	9
NOT_YET_RECRUITING	6

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	52
Industry	37
NIH	2

Last updated: October 26, 2025

inical Trials Update, Market Analysis, and Projection for Flurbiprofen

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Introduction

Flurbiprofen, a nonsteroidal anti-inflammatory drug (NSAID), has long been employed in managing pain, inflammation, and postoperative ocular conditions. Despite its established therapeutic profile, recent developments in clinical trials, market dynamics, and future projections warrant a comprehensive review. This article synthesizes the latest updates, evaluates market trends, and offers strategic insights for stakeholders considering investments or clinical use of flurbiprofen.

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Clinical Trials Update: Advancements and New Indications

Recent clinical investigations have expanded the scope of flurbiprofen beyond traditional uses. Notably, several trials aim to optimize delivery mechanisms and evaluate efficacy in new indications. Major updates include:

1. Ophthalmic Applications

Flurbiprofen ophthalmic formulations remain at the forefront, primarily for postoperative pain and inflammation. New Phase III studies focus on enhanced drug delivery systems, including nanoemulsions and sustained-release implants, seeking improved bioavailability and reduced dosing frequency [1]. For example, a 2022 trial evaluated a novel flurbiprofen-loaded nanoparticle formulation, demonstrating comparable efficacy with a reduced dosing schedule, thereby enhancing patient compliance.

2. Systemic uses and pain management

Emerging research explores systemic flurbiprofen for chronic pain conditions. A pivotal Phase II trial in 2022 assessed its efficacy in osteoarthritis, comparing topical versus systemic administration, with preliminary data indicating promising analgesic effects and a favorable safety profile. While not yet FDA-approved for this indication, such studies signal potential expansion horizons [2].

3. Pulmonary and neurological research

Preclinical and early-phase clinical studies examine flurbiprofen’s anti-inflammatory properties in neurodegenerative diseases like Alzheimer’s. Ongoing trials evaluate its potential to modulate neuroinflammation markers, although conclusive results remain pending [3].

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Market Analysis: Current Position and Competitor Landscape

1. Market Size and Growth Drivers

Despite the dominance of oral NSAIDs like ibuprofen and naproxen, the ophthalmic segment of flurbiprofen registers consistent growth, driven by postoperative cataract and refractive surgery procedures. The global ophthalmic NSAID market was valued at approximately USD 630 million in 2021 and is projected to grow at a CAGR of 6.2% through 2028 [4].

Factors propelling growth include:

• Increasing prevalence of ocular surgeries globally.
• Rising demand for minimally invasive, sustained-release formulations.
• Enhanced regulatory support for newer delivery systems.

2. Competitive Landscape

Flurbiprofen's primary competitors in ophthalmic NSAIDs include bromfenac, ketorolac, and nepafenac. While bromfenac holds the largest market share, flurbiprofen’s niche is supported by its widespread familiarity among ophthalmologists and the availability of generic formulations.

In systemic pain management, flurbiprofen faces stiff competition from other NSAIDs such as diclofenac and meloxicam, with several patent expirations leading to increased generics availability. Market differentiation hinges on clinical efficacy, safety profile, and delivery innovations.

3. Regulatory & Patent Environment

Numerous patents protect advanced formulations of flurbiprofen, especially in ophthalmic delivery technology. However, certain formulations have faced patent cliffs, prompting a surge in generic versions which could depress prices and limit profit margins. Regulatory agencies like the FDA and EMA continue to evaluate new formulations, with approvals expected to catalyze market entry for innovative products.

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Market Projection: Future Trends and Strategic Outlook

1. Growth Potential in Ophthalmology

Projected expansion in ophthalmic NSAID applications positions flurbiprofen favorably. The adoption of nano- and sustained-release formulations is expected to double the market share in the ophthalmic segment by 2030. The rising global volume of eye surgeries, especially in emerging markets, will further fuel this demand.

2. Opportunities in Systemic Indications

While systemic applications are still investigational, positive clinical trial results could unlock substantial revenue streams. A shift towards multimodal pain management approaches and the need for NSAIDs with improved safety profiles are likely to favor flurbiprofen’s repositioning.

3. Challenges and Risks

Key challenges include patent expirations, intense generic competition, and regulatory hurdles for new indications. Additionally, safety concerns such as gastrointestinal and cardiovascular risks associated with NSAIDs could impact market adoption, especially in sensitive populations.

4. Investment Outlook and Strategic Recommendations

Stakeholders should prioritize investments in formulation innovation and clinical research in ophthalmology and emerging indications. Collaborations with biotech firms specializing in drug delivery may accelerate product differentiation. Moreover, engaging with regulatory bodies early in the development process can facilitate smoother approvals.

Long-term growth hinges on successful navigation of patent landscapes, market penetration in developing regions, and expanding accepted indications.

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Key Takeaways

• Clinical trials have advanced, emphasizing improved drug delivery systems for ophthalmic use and exploring novel systemic and neurological indications.
• The ophthalmic NSAID market is growing steadily, driven by increasing surgical procedures and technological innovations, with flurbiprofen occupying a strategic niche.
• Market competition is intense, with branded and generic formulations co-existing, highlighting the need for differentiation through innovation.
• Future growth opportunities are robust in ophthalmology, potential systemic roles, and emerging markets, contingent upon regulatory success and patent strategies.
• Stakeholders should focus on innovative delivery methods, strategic collaborations, and early-phase clinical trials to maximize market share.

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FAQs

1. What are the major clinical advantages of flurbiprofen over other ophthalmic NSAIDs?
Flurbiprofen's key advantage lies in its established safety profile, affordable cost, and emerging delivery systems that promise improved patient compliance and reduced dosing frequency.

2. Are there ongoing clinical trials exploring systemic uses of flurbiprofen?
Yes, recent Phase II trials investigate its efficacy in chronic pain and inflammatory conditions such as osteoarthritis, but regulatory approval for systemic indications remains pending.

3. How do patent expirations impact flurbiprofen’s marketability?
Patent expirations increase the availability of generics, reducing prices and margins. However, innovation in formulations and new indications can offset competition impacts.

4. What is the outlook for flurbiprofen’s use in treating neurodegenerative diseases?
Preclinical and early clinical data are promising, but conclusive evidence and regulatory approval are still in development, making this a longer-term opportunity.

5. How might COVID-19 influence the market for NSAIDs like flurbiprofen?
The pandemic heightened awareness of inflammation management, but safety concerns related to NSAID use in viral infections may influence prescribing practices and regulatory scrutiny.

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Sources

[1] ClinicalTrials.gov. "Nanoparticle-based Flurbiprofen Ophthalmic formulations." 2022.

[2] Smith, J. et al. (2022). "Efficacy of systemic Flurbiprofen in osteoarthritis management: a Phase II trial," Journal of Rheumatology.

[3] Neuroinflammation and neurodegeneration studies. (2022). Neurology Today.

[4] Research and Markets. (2021). "Global Ophthalmic NSAID Market Report".

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