EP0785779A1 - Low dosage ketoprofen - Google Patents

Low dosage ketoprofen

Info

Publication number
EP0785779A1
EP0785779A1 EP95914079A EP95914079A EP0785779A1 EP 0785779 A1 EP0785779 A1 EP 0785779A1 EP 95914079 A EP95914079 A EP 95914079A EP 95914079 A EP95914079 A EP 95914079A EP 0785779 A1 EP0785779 A1 EP 0785779A1
Authority
EP
European Patent Office
Prior art keywords
ketoprofen
low dosage
pain
dosage
over
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP95914079A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP0785779A4 (show.php
Inventor
Georg Frank
Manfred Hanisch
Albrecht Hoburg
Bernhard Streuff
Daniel E. Wagner
William G. Byrd
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer AG
Bayer Corp
Original Assignee
Bayer AG
Bayer Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bayer AG, Bayer Corp filed Critical Bayer AG
Publication of EP0785779A4 publication Critical patent/EP0785779A4/xx
Publication of EP0785779A1 publication Critical patent/EP0785779A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid

Definitions

  • 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.
  • 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.
  • 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.
  • ketoprofen at a dosage of 12.5 mg would be an effective analgesic and could be used for over-the-counter use.
  • ketoprofen 12.5 mg and 25 mg 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.
  • ketoprofen 12.5 and 25 mg to acetaminophen 500 and 1000 mg Another dental pain study in Europe compared the efficacy of ketoprofen 12.5 and 25 mg to acetaminophen 500 and 1000 mg.
  • 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.
  • ketoprofen 12.5 mg and TYLENOL 650 mg are both significantly more effective than placebo and not significantly different from each other.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
EP95914079A 1994-03-18 1995-03-15 Low dosage ketoprofen Withdrawn EP0785779A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US21083294A 1994-03-18 1994-03-18
US210832 1994-03-18
PCT/US1995/003335 WO1995025511A1 (en) 1994-03-18 1995-03-15 Low dosage ketoprofen

Publications (2)

Publication Number Publication Date
EP0785779A4 EP0785779A4 (show.php) 1997-07-30
EP0785779A1 true EP0785779A1 (en) 1997-07-30

Family

ID=22784436

Family Applications (1)

Application Number Title Priority Date Filing Date
EP95914079A Withdrawn EP0785779A1 (en) 1994-03-18 1995-03-15 Low dosage ketoprofen

Country Status (4)

Country Link
EP (1) EP0785779A1 (show.php)
AU (1) AU2121895A (show.php)
CA (1) CA2185805A1 (show.php)
WO (1) WO1995025511A1 (show.php)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL124419A0 (en) * 1995-12-07 1998-12-06 Lilly Co Eli Composition for treating pain

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1546478A (fr) * 1967-01-27 1968-11-22 Rhone Poulenc Sa Nouveaux dérivés de l'acide benzoyl-3 phénylacétique et leur préparation
US4868214A (en) * 1987-11-17 1989-09-19 Analgesic Associates Onset-hastened/enhanced analgesia
US4962124A (en) * 1987-11-17 1990-10-09 Analgesic Associates Onset-hastened/enhanced antipyretic response
US5331000A (en) * 1992-03-09 1994-07-19 Sepracor Inc. Antipyretic and analgesic methods and compositions containing optically pure R(-) ketoprofen

Also Published As

Publication number Publication date
EP0785779A4 (show.php) 1997-07-30
WO1995025511A1 (en) 1995-09-28
AU2121895A (en) 1995-10-09
CA2185805A1 (en) 1995-09-28

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Legal Events

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PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

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17P Request for examination filed

Effective date: 19960918

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Effective date: 19970613