LOW DOSAGE KETOPROFEN

Abstract: It has been found that 12.5 mg ketoprofen is an effective analgesic and antipyretic. This low dosage is suitable for over-the-counter availability.

Description: LOW DOSAGE KETOPROFEN FIELD OF THE INVENTION The field of the invention is analgesics for use in the over- the-counter market in general and is a particularly low dosage of ketoprofen for effective pain relief in the over-the-counter market in particular. BACKGROUND OF THE INVENTION Ketoprofen, is a non-steroidal anti-inflammatory in the same chemical class as ibuprofen, is marketed for prescription use in the United States as ORUDIS by Wyeth-Ayerst. The product is available as 25, 50 and 75 mg capsules. The recommended daily dose of ORUDIS is 150 to 300 mg divided in three or four doses, ie approximately 50 to 100 mg per dose. The usual dose of ORUDIS recommended for mild to moderate pain and dysmenorrhea is 25 to 50 mg every 6 to 8 hours as necessary. It has been desired to make this analgesic available as an over-the-counter (OTC) medication by a mechanism known as an Rx to OTC switch. Generally the OTC dosage of a medication is lower than the Rx dosage because such medication could be purchased by individuals without the supervision of a physician. That dosage must be effective and yet safe for OTC analgesic use. SUMMARY OF THE INVENTION The applicant herein proposed, and it has since been proven, that ketoprofen at a dosage of 12.5 mg would be an effective analgesic and could be used for over-the-counter use. DESCRIPTION OF THE CLINICAL SUPPORT FOR LOW DOSAGE KETOPROFEN Clinical studies have been conducted utilizing various pain models including dental pain and post-episiotomy pain. In addition, a clinical trial has been conducted to evaluate the efficacy of ketoprofen 12.5 mg as an antipyretic. Results of a ketoprofen study in Europe utilizing a headache model indicated that there were no meaningful differences between ketoprofen 12.5 mg and 25 mg, ibuprofen 200 mg and naproxen sodium 275 mg to relieve tension-type headache two hours after administration in outpatients of general practitioners. The results of one dental pain study indicated that both 12.5 mg of ketoprofen and 650 mg of aspirin are superior to placebo for pain relief but are not statistically significantly different from each other. Another dental pain study in Europe compared the efficacy of ketoprofen 12.5 and 25 mg to acetaminophen 500 and 1000 mg. In " general ketoprofen and acetaminophen provided similar results and both active drugs were significantly better than placebo. Both forms of ketoprofen provided a significantly greater amount of pain relief at one hour ("Time of Onset") than placebo, while acetaminophen did not. Yet a third dental pain study indicated that ketoprofen 12.5 mg and TYLENOL 650 mg are both significantly more effective than placebo and not significantly different from each other. Initial investigations assessing the efficacy of ketoprofen 12.5 and 25 mg when compared to ibuprofen 200 mg and placebo indicate that is effective at both dosage levels for dysmennorhea.

Claims: WHAT IS CLAIMED IS: 1. A method of treating pain with a 12.5 mg ketoprofen to provide safe and effective relief. 2. A method of treating symptoms of pain, discomfort and fever with a 12.5 mg ketoprofen to provide safe and effective relief. 3. An over-the-counter analgesic tablet, comprising 12.5 mg ketoprofen.

Inventors: BYRD WILLIAM G, FRANK GEORG, HANISCH MANFRED, HOBURG ALBRECHT, STREUFF BERNHARD, WAGNER DANIEL E, BYRD, WILLIAM, G., FRANK, GEORG, HANISCH, MANFRED, HOBURG, ALBRECHT, STREUFF, BERNHARD, WAGNER, DANIEL, E.
Applicants: BYRD WILLIAM G, FRANK GEORG, HANISCH MANFRED, HOBURG ALBRECHT, MILES INC, STREUFF BERNHARD, WAGNER DANIEL E, BYRD, WILLIAM, G., FRANK, GEORG, HANISCH, MANFRED, HOBURG, ALBRECHT, MILES INC., STREUFF, BERNHARD, WAGNER, DANIEL, E.
Application year: 1995
Main classification: A61K31
IPC codes: A61K31