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
Healthy Volunteers	7
Pain	7
Healthy	6
Anesthesia	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	14
Switzerland	7
Australia	7
Germany	3

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
Phase 4	12
Phase 3	3
Phase 2	8

Clinical Trial Status

Clinical Trial Status for Flurbiprofen
Clinical Trial Phase	Trials
Completed	42
Not yet recruiting	9
Unknown status	6

Clinical Trial Sponsors for Flurbiprofen

Sponsor Name

Sponsor Name for Flurbiprofen
Sponsor	Trials
Bristol-Myers Squibb	8
GlaxoSmithKline	3
Beijing Friendship Hospital	3

Sponsor Type

Sponsor Type for Flurbiprofen
Sponsor	Trials
Other	38
Industry	32
NIH	2

Flurbiprofen: Clinical Trials, Market Analysis, and Projections

Last updated: December 31, 2024

Introduction to Flurbiprofen

Flurbiprofen is a nonsteroidal anti-inflammatory drug (NSAID) widely used for its analgesic, anti-inflammatory, and antipyretic properties. It is available in various formulations, including lozenges, patches, tablets, and injections, catering to different medical needs such as pain relief, joint and muscle pain, and post-operative pain.

Clinical Trials Overview

Safety and Efficacy in Pharyngitis Treatment

Several clinical trials have evaluated the safety and efficacy of flurbiprofen, particularly in the treatment of painful pharyngitis. Two notable trials, NCT01048866 and NCT01049334, were randomized double-blind placebo-controlled studies that compared the safety and efficacy of flurbiprofen 8.75 mg lozenges to placebo lozenges in patients with painful pharyngitis.

• In these trials, the incidence of hemorrhagic events was low and not significantly different between the flurbiprofen and placebo groups. For example, in NCT01048866, the risk of hemorrhagic events was 1.98% with flurbiprofen and 2.06% with the placebo, while in NCT01049334, it was 1.96% with flurbiprofen and 0.98% with the placebo[1].

Topical Use in Knee Osteoarthritis

A phase III, multi-center, randomized trial examined the effectiveness of S-flurbiprofen plaster (SFPP) compared to a flurbiprofen patch in treating knee osteoarthritis. This study involved 633 patients treated with either SFPP or the flurbiprofen patch for two weeks.

• The primary endpoint was the improvement in knee pain on rising from a chair, assessed by a visual analogue scale. The study found that both treatments were effective, but SFPP showed a slightly better safety profile, particularly in terms of local adverse events at the application site[3].

Market Analysis

Current Market Size and Growth

The flurbiprofen market has experienced significant growth in recent years and is projected to continue this trend. As of 2023, the market size was substantial, and it is anticipated to reach even higher values by 2031, exhibiting a compound annual growth rate (CAGR) that indicates robust expansion.

• The market is segmented based on type (injection, patch, tablet) and application (nonsteroidal anti-inflammatory drugs, topical administration for joint and muscle pain, soft tissue disease, dysmenorrhea, post-operative pain, toothache, etc.), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2][4].

Market Dynamics

The flurbiprofen market is influenced by several key factors:

• Drivers: Increasing prevalence of musculoskeletal diseases, growing demand for pain relief medications, and the convenience of topical formulations.
• Restraints: Potential side effects associated with NSAIDs, such as gastrointestinal bleeding, and regulatory challenges.
• Opportunities: Expanding into new geographical markets, developing new formulations, and increasing awareness about the benefits of topical NSAIDs.
• Challenges: Competition from other NSAIDs and alternative pain relief options, as well as economic and political factors affecting healthcare spending[2][4].

Market Projections

Forecast Period

The market is forecasted to grow significantly from 2023 to 2031. This growth is attributed to the increasing demand for effective pain relief solutions, the convenience and safety of topical formulations like patches and lozenges, and the expanding reach into new markets.

• The report provides a comprehensive evaluation of the market, including trends, key factors shaping the market, and detailed analyses of product pricing, market penetration, and consumer behavior[2][4].

Regional Outlook

The flurbiprofen market is expected to see substantial growth across various regions:

• Asia-Pacific: This region is anticipated to be a major driver due to its large population and increasing healthcare spending.
• North America and Europe: These regions will continue to be significant markets due to their established healthcare systems and high demand for pain relief medications.
• South America and Middle-East and Africa: These regions are expected to show growth as healthcare infrastructure improves and awareness about flurbiprofen increases[2][4].

Key Takeaways

• Clinical Trials: Flurbiprofen has shown safety and efficacy in treating painful pharyngitis and knee osteoarthritis, with low incidence of serious adverse events.
• Market Growth: The flurbiprofen market is experiencing rapid growth and is projected to continue expanding through 2031.
• Market Segmentation: The market is segmented by type, application, and geographical region, with topical formulations being a significant segment.
• Market Dynamics: The market is driven by increasing demand for pain relief, convenience of topical formulations, and expanding into new markets, but faces restraints such as potential side effects and regulatory challenges.

FAQs

What are the common formulations of flurbiprofen?

Flurbiprofen is available in various formulations including lozenges, patches, tablets, and injections, each catering to different medical needs.

What are the primary applications of flurbiprofen?

Flurbiprofen is used for pain relief, treatment of joint and muscle pain, soft tissue disease, dysmenorrhea, post-operative pain, and toothache.

What are the key findings from clinical trials on flurbiprofen?

Clinical trials have shown that flurbiprofen is safe and effective for treating painful pharyngitis and knee osteoarthritis, with a low incidence of serious adverse events.

What is the projected growth of the flurbiprofen market?

The flurbiprofen market is expected to grow significantly from 2023 to 2031, driven by increasing demand for pain relief and the convenience of topical formulations.

Which regions are expected to drive the growth of the flurbiprofen market?

The Asia-Pacific region is anticipated to be a major driver, along with continued significant contributions from North America and Europe, and growing demand in South America and the Middle-East and Africa.

Sources

1. Frontiers in Pharmacology: "A Systematic Review of Flurbiprofen 8.75 mg Dose and Risk of Haemorrhagic Events" (2021)
2. Market Research Intellect: "Global Flurbiprofen Market Size, Scope And Forecast Report" (2024)
3. Oxford University Press: "Efficacy of S-flurbiprofen plaster in knee osteoarthritis treatment" (2023)
4. Market Research Intellect: "Global Flurbiprofen Market Size, Trends and Projections" (2024)