Compositions containing the nonprescription combination of acetaminophen, aspirin and caffeine to alleviate the pain and symptoms of migraine

• US 5,972,916 A
• Filed: 02/10/1998
• Issued: 10/26/1999
• Est. Priority Date: 07/14/1997
• Status: Expired due to Term

• Current Assignee: Novartis Ag
• Original Assignee: Bristol-Myers Squibb Company
• Inventors: Koslo, Randy, Armellino, Joseph
• Primary Examiner(s): Spivack, Phyllis G.
• Application Number:
  US09/021,284
• Time in Patent Office: 623 Days
• Field of Search: 514/264, 514/165, 514/630
• US Class Current: 514/165
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/52 Purines, e.g. adenine
• CPC Class Codes: A61K 31/60 Salicylic acid; Derivatives thereof
• CPC Class Codes: A61K 31/621 having the hydroxy group in position 2 esterified, e.g. benorylate
• CPC Class Codes: A61P 25/06 Antimigraine agents
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

The invention provides a safe and economical nonprescription combination of acetaminophen, aspirin and caffeine (APAP/ASA/CAF) for use in treating migraine pain and the cluster of symptoms characteristic of migraine attack, such as nausea, photophobia, phonophobia and functional disabilities. The use of the APAP/ASA/CAF combination is also effective in aborting the prodrome phase of a migraine attack.

Claims

1. A method for treating migraine pain and the cluster of symptoms characteristic of a migraine attack, the symptoms selected from the group consisting of nausea, photophobia, phonophobia and functional disability, comprising administering to a human subject a composition comprising a combination of acetaminophen, aspirin and caffeine in an amount effective to reduce or eliminate the migraine pain and one or more of said symptoms characteristic of migraine.

2. The method according to claim 1, wherein two or more of said symptoms characteristic of migraine are reduced or eliminated.

3. The method according to claim 1, wherein said composition is administered in a solid oral dosage form.

4. The method according to claim 3, wherein said dosage form is selected from the group consisting of tablets, pills, caplets and capsules.

5. The method according to claim 1, wherein said composition is administered as a suppository.

6. The method according to claim 4, wherein a single tablet, pill or capsule of said solid dosage form comprises acetaminophen in an amount of from about 200 to about 300 mg;

aspirin in an amount of from about 200 to about 300 mg; and

caffeine in an amount of about 55 to about 100 mg.

7. The method according to claim 5, wherein said composition comprises acetaminophen in an amount of 250 mg;

aspirin in an amount of 250 mg; and

caffeine in an amount of 65 mg.

8. The method according to claim 5, wherein two tablets, pills or capsules are administered to the human host about every four to six hours.

9. The method according to claim 7, wherein said composition is not readministered to said subject more frequently than once every six hours.

10. The method according to claim 1, wherein the amount of composition administered is effective to reduce or eliminate the migraine pain and two or more of said symptoms characteristic of migraine.

11. The method according to claim 1, wherein the amount of composition administered is effective to reduce or eliminate the migraine pain and three or more of said symptoms characteristic of migraine.

12. The method according to claim 1, wherein the amount of composition administered is effective to reduce or eliminate the migraine pain and all four of said symptoms characteristic of migraine.

13. A method of aborting a migraine attack, wherein the migraine attack is characterized by any one of the symptoms selected from the group consisting of nausea, photophobia, phonophobia and functional disability, comprising administering to a human subject during the prodrome phase of the migraine attack a migraine abortive effective amount of a composition comprising a combination of acetaminophen, aspirin and caffeine.

14. A method for treating migraine pain and nausea characteristic of a migraine attack comprising administering to a human subject a composition comprising a combination of acetaminophen, aspirin, and caffeine in an amount effective to reduce or eliminate the migraine pain and nausea characteristic of a migraine attack.

15. A method for treating migraine pain and photophobia characteristic of a migraine attack comprising administering to a human subject a composition comprising a combination of acetaminophen, aspirin, and caffeine in an amount effective to reduce or eliminate the migraine pain and photophobia characteristic of a migraine attack.

16. A method for treating migraine pain and phonophobia characteristic of a migraine attack comprising administering to a human subject a composition comprising a combination of acetaminophen, aspirin, and caffeine in an amount effective to reduce or eliminate the migraine pain and phonophobia characteristic of a migraine attack.

17. A method for treating migraine pain and functional disability characteristic of a migraine attack comprising administering to a human subject a composition comprising a combination of acetaminophen, aspirin, and caffeine in an amount effective to reduce or eliminate the migraine pain and functional disability characteristic of a migraine attack.