Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
2000-01-18
2003-07-15
Criares, Theodore J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C514S403000
Reexamination Certificate
active
06593368
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to novel combinations of anti-epileptic compounds that demonstrate pain alleviating properties, with compounds selected from the group consisting of analgesics, N-methyl-D-aspartate (NMDA) receptor antagonists and non-steroidal anti-inflammatory drugs (NSAIDs) and pharmaceutical compositions comprising same. It has been discovered that the administration of anti-epileptic compounds that demonstrate pain alleviating properties in these novel combinations results in an improved reduction in the frequency and severity of pain. It is also believed that the incidence of unwanted side effects can be reduced by these novel combinations in comparison to using higher doses of a single agent treatment to achieve a similar therapeutic effect. The present invention is also directed to methods of using effective amounts of the novel pharmaceutical compositions to treat pain in mammals.
BACKGROUND OF THE INVENTION
A number of treatments involving the administration of single drugs are currently recommended for pain relief. The single administration of narcotic and non-narcotic analgesics and NSAIDs have been shown to display pain alleviating properties. Some anti-epileptics, such as gabapentin and pregabalin, have also demonstrated pain alleviating properties.
Despite the benefits derived from current single drug pain relief regimens, these regimens have disadvantages. One area of concern relates to the incidence of unwanted side effects caused by many of the pain treatment regimens available today. Narcotic analgesics, such as morphine, are sparingly prescribed for pain because of the well-known addictive effects and significant central nervous system (CNS) side effects and gastrointestinal side effects resulting from their single administration. Another class of drugs often used alone for treatment of pain, non-steroidal anti-inflammatory drugs, such as ibuprofen and naproxen, are criticized for their irritation of the gastrointestinal tract.
Another concern of current pain treatment regimens relates to their effectiveness Many single active ingredients employed in current pain relief regimens cannot achieve adequate pain alleviation even at their maximum therapeutic approved doses in some severe pain states. In addition to not achieving adequate pain alleviation, increasing the drug dose may produce an increase in unwanted side effects such as cognitive impairment, nausea, and constipation.
In view of these concerns, it is evident that there is a need for an improved pain regimen that provides an improved therapeutic benefit (ie, reduced severity and/or frequency of pain) and/or reduces the incidence of unwanted side effects caused by many of the current regimens.
SUMMARY OF THE INVENTION
The inventors have now surprisingly found that anti-epileptic compounds having pain alleviating properties, when co-administered with compounds selected from the group consisting of analgesics. NMDA receptor antagonists, and NSAIDs, result in unexpected improved pain relief.
The present invention is directed to novel combinations for alleviating pain, the combinations comprising of anti-epileptic compounds, such as gabapentin and pregabalin, that have displayed pain alleviating properties, and compounds selected from the group consisting of NMDA receptor antagonists, analgesics, and NSAIDs. It is also believed that the incidence of unwanted side effects can be reduced by co-administration of these compounds with anti-epileptic compounds having pain alleviating properties in comparison to using higher doses of a single agent treatment to achieve a similar therapeutic effect.
The present invention is also directed to pharmaceutical compositions comprising the novel combinations of certain anti-epileptic compounds with compounds selected from the group consisting of NMDA receptor antagonists, analgesics, and NSAIDs. The active ingredients are combined with at least one pharmaceutically acceptable carrier. The novel pharmaceutical compositions are prepared in a wide variety of pharmaceutical delivery systems known to those of skill in the art, preferably oral and parenteral dosage forms.
The present invention is also directed to methods of treating mammals suffering from pain with the novel pharmaceutical composition to alleviate pain. The method comprises the step of administering the pharmaceutical compositions comprising the novel anti-epileptic combinations to mammals in need of pain relief.
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Magnus-Miller Leslie
Saltel Douglas A.
Ashbrook Charles W.
Atkins Michael J.
Criares Theodore J.
Kim Jennifer
Purchase, Jr. Claude F.
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