Ocufen (Flurbiprofen Sodium Ophthalmic) - Summary

OCUFEN SUMMARY

OCUFEN^®
(flurbiprofen sodium ophthalmic solution, USP) 0.03%

OCUFEN^® (flurbiprofen sodium ophthalmic solution, USP) 0.03% is a sterile topical nonsteroidal anti-inflammatory product for ophthalmic use. Chemical Name: Sodium (±)-2-(2-fluoro-4-biphenylyl)-propionate dihydrate.

OCUFEN^® ophthalmic solution is indicated for the inhibition of intraoperative miosis.

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NEWS HIGHLIGHTS

Published Studies Related to Ocufen (Flurbiprofen Ophthalmic)

Pretreatment with flurbiprofen axetil, flurbiprofen axetil preceded by venous occlusion, and a mixture of flurbiprofen axetil and propofol in reducing pain on injection of propofol in adult Japanese surgical patients: a prospective, randomized, double-blind, placebo-controlled study. [2009.04]
BACKGROUND: Pain on injection of propofol is a common clinical problem. Flurbiprofen axetil, an injectable prodrug of flurbiprofen, with or without venous occlusion has been reported to reduce this pain. A search of the existing literature did not identify comparative studies of 3 different techniques, including pretreatment with flurbiprofen axetil, flurbiprofen axetil preceded by venous occlusion, and mixture of propofol and flurbiprofen axetil, for reducing pain on injection of propofol. OBJECTIVE: The aim of this study was to compare the effectiveness of these 3 different techniques of flurbiprofen axetil administration in reducing pain on injection of propofol... CONCLUSION: In this study of adult Japanese surgical patients, pretreatment with flurbiprofen axetil 50 mg preceded by venous occlusion was found to be more effective in reducing pain on injection of propofol than the other flurbiprofen axetil administration strategies tested.

Clinical study on the bioequivalence of two tablet formulations of flurbiprofen. [2009.01]
Flurbiprofen (CAS 5104-49-4) is a member of phenylalkanoic acid derivative group of nonsteroid anti-inflammatory drugs... All these values were within the acceptance range (80%-125%) for bioequivalence studies.

Safety, tolerability, pharmacokinetics, and Abeta levels after short-term administration of R-flurbiprofen in healthy elderly individuals. [2007.10]
To evaluate the safety and tolerability and pharmacokinetic properties of R-flurbiprofen (Tarenflurbil) in normal elderly individuals and to determine the effect of the drug on amyloid beta 42 (Abeta42) levels, we conducted a double-blind, placebo-controlled study of 48 healthy subjects aged 55 to 80...

Validation of incorporating flurbiprofen into the Pittsburgh cocktail. [2006.09]
BACKGROUND: We have previously shown that flurbiprofen metabolism to 4'-hydroxyflurbiprofen provides an in vivo measure of cytochrome P450 (CYP) 2C9 activity. This study evaluated the possibility of incorporating flurbiprofen into the current 5-drug Pittsburgh cocktail... CONCLUSION: The results of this study show that caffeine (CYP1A2), chlorzoxazone (CYP2E1), dapsone (N-acetyltransferase 2), debrisoquin (CYP2D6), flurbiprofen (CYP2C9), and mephenytoin (CYP2C19) can be simultaneously administered in low doses without metabolic interaction.

Influence of age on flurbiprofen axetil requirements for preventing pain on injection of propofol in Japanese adult surgical patients: a prospective, randomized, double-blind, vehicle-controlled, parallel-group, dose-ranging study. [2006.08]
BACKGROUND: Pain on injection is a recognized adverse event (AE) of propofol administration for the induction of general anesthesia. Preceded by venous occlusion, flurbiprofen axetil, a prodrug of the NSAID flurbiprofen, has been associated with a reduction in pain induced by propofol injection. A review of the literature determined that no published data were available on the influence of age on the requirements for flurbiprofen axetil dose. OBJECTIVE: This study was undertaken to examine the influence of age on flurbiprofen axetil requirements for the treatment of propofol-induced pain on injection in Japanese adult surgical patients... CONCLUSIONS: In this small clinical trial in Japanese surgical patients undergoing general anesthesia, flurbiprofen axetil requirements for the reduction of pain during injection of propofol were found to be 50 mg in young adults (age 20-40 years) and 25 or 50 mg in older adults (age 60-80 years), regardless of weight, preceded by venous occlusion for 2 minutes.

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Clinical Trials Related to Ocufen (Flurbiprofen Ophthalmic)

Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction [Completed]
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.

The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis [Not yet recruiting]

R-Flurbiprofen in Treating Patients With Localized Prostate Cancer at Risk of Recurrence [Active, not recruiting]
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.

Validation Study of Multiple Probe Compounds for Drug Interaction Evaluation [Not yet recruiting]
The purpose of this study is to identify and validate a probe cocktail for use in future GSK drug-drug interaction studies. Cytochrome P450 enzymes and transport proteins play important roles in the disposition of drugs. Changes in the activity of these pathways can be assessed using probe drugs selected on the basis of their metabolic or transport pathway. This will be a two part study with the same subjects participating in both parts to decrease variability in data. The purpose of Part 1 is to identify a set of probe drugs ('cocktail') which do not interact with one another; groups of healthy volunteers will receive 7 probe drugs individually and as a single combination of the 7 drugs given together as a cocktail. The pathways which mediate clearance of the selected probe drugs are CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP3A4, CYP2D6 and OATP1B1. Between Part 1 and 2, there will be a pharmacokinetic analysis period of approximately 6 weeks when subjects do not have to visit the clinic. If substantial PK interactions are observed, a conditional Part 1B may be performed to evaluate a modified cocktail where probes subject to interaction are removed. Part 2 will assess the performance of the probe cocktail using three known inhibitors (validation). The inhibitors plus probe cocktail will evaluate the ability of the newly established cocktail to accurately quantify metabolizing enzyme or transporter inhibition, representing a fundamental advance in probe cocktail validation and utility for drug development.

A Placebo-Controlled Study to Investigate the Safety, and Pharmacokinetics of Oral GSK626616AC in Healthy Subjects [Completed]
This is a first time in human study to investigate the safety of GSK626616AC given as oral single and repeat doses in healthy subjects. An additional group of subjects will be assessed to determine the effect of several drugs given at the same time as GSK626616.

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