Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1999-11-11
2001-06-12
Spivack, Phyllis G. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S568000
Reexamination Certificate
active
06245802
ABSTRACT:
BACKGROUND OF THE INVENTION
For many types of pain, the method for treating the pain is through administration of aspirin or any of a number of non-steroidal antiinflammatory agents, NSAIDs. Frequently, the administration of the NSAID provides the relief sought. However, if the relief of pain is insufficient with NSAIDs alone, these agents may be combined with orally effective morphine-like agents, such as codeine and other opioids. Because these two agents exert their effects by different mechanisms, combinations of these two classes of drugs usually can achieve an analgesic effect that would otherwise require a higher dose of opioid, but with fewer side effects. Nonetheless, even at a lesser dose of opioid, resulting in fewer side effects, it has been well documented that any dose of an opioid has the potential for severe side effects. For example, morphine and its related opioids may cause respiratory depression, nausea, vomiting, dizziness, mental clouding, dysphoria, pruritus, constipation, increased pressure in the biliary tract, urinary retention, hypotension, tolerance, and physical dependence. (
The Pharmacological Basis of Therapeutics,
9th edition, Macmillan Publishing Co., 1996, pp 533-540.)
New safer and effective methods for the treatment of pain are in constant demand. The discovery of other agents which provide an analgesic synergism in combination with NSAIDs but have a reduction in the severity of the side effects profile are in constant demand. Such a combination is the subject of the present invention.
The present invention addresses a long felt need for a safe and effective treatment for pain.
SUMMARY OF THE INVENTION
The present invention provides a method for treating pain in a mammal requiring said treatment, which comprises administering to said mammal an effective amount of duloxetine or a pharmaceutically acceptable salt or solvate thereof; in combination with an effective amount of one or more NSAIDs.
The present invention also provides the use of duloxetine or a pharmaceutically acceptable salt or solvate thereof in combination with one or more NSAIDs for the manufacture of a medicament for treating pain.
Furthermore, the present invention provides the use of duloxetine or a pharmaceutically acceptable salt or solvate thereof in combination with one or more NSAIDs for treating persistent pain.
According to yet another aspect, the present invention provides a pharmaceutical formulation comprising a combination of duloxetine, or a pharmaceutically acceptable salt or solvate thereof, one or more NSAIDs, and a pharmaceutical carrier, diluent or excipient.
REFERENCES:
patent: 0 908 186 (1998-08-01), None
patent: WO 97/35584 (1997-03-01), None
patent: 98/46601 (1998-10-01), None
Mark J. Millan, et al., Way 100,635 enhances both the “antidepressant” actions of duloxetine and its influence on dialysate levels of serotonin in frontal cortex,European Journal of Pharmacology341 (1998), pp. 165-167.
Iyengar Smriti
Jones Carrie Kimberly
Shannon Harlan Edgar
Anderson Arvie J.
Eli Lilly and Company
Harvey Suzanne M.
Spivack Phyllis G.
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