Method for treating pain

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...

Reexamination Certificate

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C514S211070, C514S258100, C514S323000, C514S420000, C514S431000, C514S570000, C514S629000, C514S165000

Reexamination Certificate

active

06444665

ABSTRACT:

FIELD OF THE INVENTION
This invention provides a method for using an atypical antipsychotic compound selected from the group consisting of risperidone, clozapine, seroquel, sertindole, ziprasidone, and zotepine for the treatment of pain.
BACKGROUND OF THE INVENTION
This invention relates to the treatment of pain using atypical antipsychotic compounds to provide analgesic activity.
Surprisingly, we have discovered that atypical antipsychotic compounds can be particular useful for treating pain. The analgesic effect may be further enhanced when used in combination with one or more another Drug Used in the Treatment of Pain compounds. More specifically, the invention provides a method of treating pain in humans using an atypical antipsychotic compound.
There are drugs used in the treatment of pain which known in the literature and to the skilled artisan. see for example, Merck Manual, 16th Ed. (1992) p. 1409.
More active analgesics are in constant demand because they offer the attractive possibility of relieving pain with reduced dosages, thereby diminishing the expected side effects and toxicity that would otherwise result from higher dosages. It would be particularly desirable to acquire a synergistic combination effect to further reduce dosages and diminish side effects. Such a composition is a subject of the present invention.
Certain compounds have been disclosed as being atypical antipsychotics which can be useful for treating schizophrenia or related psychotic conditions. Applicants have discovered that atypical antipsychotic compounds selected from the group consisting of risperidone, clozapine, seroquel, sertindole, ziprasidone, and zotepine can be useful for the treatment of pain and may provide a synergistic effect when administered with one or more other drugs used in the treatment of pain.
SUMMARY OF THE INVENTION
The present invention provides a method for treating pain, comprising administering an effective amount of an atypical antipsychotic selected from the group consisting of risperidone, clozapine, seroquel, sertindole, ziprasidone, and zotepine to a patient in need thereof.
The present invention further provides a method for treating pain comprising administering to a patient in need thereof, an analgesic composition comprising an atypical antipsychotic or a pharmaceutically acceptable salt thereof; and another Drug Used in the Treatment of Pain, in a weight ratio of one part atypical antipsychotic to from about one part to about one thousand (1,000) parts of another Drug Used in the Treatment of Pain.
A preferred composition is a weight ratio of atypical antipsychotic to another Drug Used in the Treatment of Pain of from about 1 part atypical antipsychotic to from about 1 part to about 100 parts of another Drug Used in the Treatment of Pain. An especially preferred ratio is from about 1 part atypical antipsychotic to from about 1 to about 30 parts another Drug Used in the Treatment of Pain. A further preferred ratio may be from about 1 part atypical antipsychotic to from about 1 part to about 10 parts another Drug Used in the Treatment of Pain. A final preferred ratio may be from about 1 part atypical antipsychotic to from about 1 to about 3 parts another Drug Used in the Treatment of Pain.
Preferably another Drug Used in the Treatment of Pain is one or more compounds selected from the group consisting of aspirin, acetominophen, paracetamol, indomethacin, Tylenol #3, tricyclic antidepressants (for example desipramine, imipramine, amytriptiline, nortriptile), anticonvulsants (for example, carbamazepine, valproate), and serotonin reuptake inhibitors (for example, fluoxetine, paraoxetine, sertraline), mixed serotonin-norepinephrine reuptake inhibitors (for example venlafaxine, duloxetine), serotonin receptor agonists and antagonists, cholinergic (muscarinic and nicotinic) analgesics, adrenergic agents, and neurokinin antagonists.
Particularly preferred Drug Used in the Treatment of Pain are selected from the group consisting of aspirin, acetominophen, ketorolac, allopurinol, methysergide maleate, and methotrimeprazine.
The invention further provides a composition for treating pain comprising an atypical antipsychotic or a pharmaceutically acceptable salt or solvate thereof and one or more another Drug Used in the Treatment of Pain in a weight ratio of atypical antipsychotic to another Drug Used in the Treatment of Pain of from about one (1) part atypical antipsychotic to from about 1 part to about 1000 parts Drug Used in the Treatment of Pain.
DETAILED DESCRIPTION OF THE INVENTION
Another Drug Used in the Treatment of Pain used primarily for the symptomatic relief of pain may be divided into four major groups: 1) opiate analgesics; 2) nonopiate analgesics; 3) analgesics and antipyretics; and 4) nonsteroidal antiinflammatory drugs. Other compounds contemplated herein as “Drug Used in the Treatment of Pain” include, but are in no way limited to other drug classes which might be used with atypical antipsychotics for the treatment of pain to provide a synergistic effect, for example, acetominophen, paracetamol, indomethacin, Tylenol #3, tricyclic antidepressants (for example desipramine, imipramine, amytriptiline, nortriptile), anticonvulsants (for example, carbamazepine, valproate), and serotonin reuptake inhibitors (for example, fluoxetine, paraoxetine, sertraline), mixed serotonin-norepinephrine reuptake inhibitors (for example venlafaxine, duloxetine), serotonin receptor agonists and antagonists, cholinergic (muscarinic and nicotinic) analgesics, adrenergic agents, and neurokinin antagonists. Some preferred another Drug Used in the Treatment of Pain s are selected from acetominphen, cholinergic analgesics, and neurokinin anatagonists. Other preferred Drug Used in the Treatment of Pain include tricyclic antidepressants, anticonvulsants, and serotonin reuptake inhibitors.
Another preferred group of Drug Used in the Treatment of Pain is nonopiate analgesics. The term “nonopiate analgesics”refer to compounds including, but not limited to Butorphanol, Propoxyphene, meperidine, alphaprodine hydrochloride, fentanyl, and tramadol.
Another preferred group of Drug Used in the Treatment of Pain is “analgesics and antipyretics” wherein the term refers to compounds such as, but not limited to, acetominophen, ketorolac, allopurinol, methysergide maleate, and methotrimeprazine.
Applicants appreciate that a new Drug Used in the Treatment of Pain may be in development, and the present invention contemplates a synergistic composition comprising such new agents with atypical antipsychotic as well.
As used herein the term “atypical antipsychotic” shall refer to a compound selected from the group consisting of risperidone, clozapine, seroquel, sertindole, ziprasidone, and zotepine.
Risperidone is a known antipsychotic compound currently marketed by Janssen and claimed by U.S. Pat. No. 5,246,935 which is hereby incorporated by reference in its entirety.
Clozapine is a well known atypical antipsychotic compound currently marketed by Sandoz.
Seroquel is a known compound claimed by U.S. Pat. No. 4,879,288 which is hereby incorporated by reference in its entirety.
Sertindole is a known compound and is claimed by U.S. Pat. Nos. 5,112,838 and 5,2238,945 each of which is hereby incorporated by reference in their entirety.
Ziprasidone is a known compound and is claimed in EP281309-A which is readily available to the skilled artisan Ziprasidone has the following structure:
Zotepine is a known compound claimed in U.S. Pat. No. 3,704,245 which is hereby incorporated by reference in its entirety. Zotepine has the following structure:
As used herein, the term “mammal” shall refer to the Mammalia class of higher vertebrates. The term “mammal” includes, but is not limited to, a human. The term “treating” as used herein includes prophylaxis of the named condition or amelioration or elimination of the condition once it has been established.
As used herein the term “Drug Used in the Treatment of Pain” refers to compounds known to be clinically useful as analgesics. The term refers to one o

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