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Method of treating thermoregulatory disfunction with paroxetine

a technology of paroxetine and thermoregulatory dysfunction, which is applied in the direction of biocide, heterocyclic compound active ingredients, drug compositions, etc., can solve the problems of significant side effects that the patient may not be willing to endure, and the patient may be reluctant or unwilling to accept hormone replacement therapy, so as to reduce side effects

Inactive Publication Date: 2008-02-07
NOVEN THERAPEUTICS +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0013]Still another object of the invention is to provide to a patient suffering from a thermoregulatory dysfunction a treatment thereof with paroxetine that substantially avoids most and / or substantially reduces the side effects typically obtained from an antidepressant effective amount of paroxetine.

Problems solved by technology

In addition, disease states which disrupt the normal hormonal control over thermoregulatory function also result in such hot flashes and flushes.
However, many women, especially those having a history or at higher risk of breast cancer, are reluctant or will not accept hormone replacement therapy.
It is generally recognized that at typical antidepressant therapeutic dosing of SSRIs (including paroxetine) there are significant side effects that the patient may not be willing to endure.
Women with menopausal hot flashes may not be willing to take antidepressant doses of antidepressant drugs both due to side effects and reluctance to take a treatment for depression.
A simple side effect to most patients who are willing to endure the side effect in other contexts may be overwhelming to those having to deal with multiple drug treatments from other conditions.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0022]Females having hot flashes associated with menopause are administered paroxetine (based on free base non-solvate, anhydrate) as follows:

Form ofParoxetineDosageHydrochloride1.0Hydrochloride2.0Hydrochloride3.0Hydrochloride4.0Hydrochloride5.0Hydrochloride6.0Hydrochloride7.0Hydrochloride8.0Hydrochloride9.0Hydrochloride9.5Mesylate1.0Mesylate2.0Mesylate3.0Mesylate4.0Mesylate5.0Mesylate6.0Mesylate7.0Mesylate8.0Mesylate9.0Mesylate9.5

[0023]After a few days to weeks, the symptoms ameliorate.

example 2

[0024]Females having hot flashes associated with menopause are administered paroxetine (based on free base non-solvate, anhydrate) as follows:

Form ofParoxetineHClDosageAnhydrous1.0Anhydrous2.0Anhydrous3.0Anhydrous4.0Anhydrous5.0Anhydrous6.0Anhydrous7.0Anhydrous8.0Anhydrous9.0Anhydrous9.5Hemihydrate1.0Hemihydrate2.0Hemihydrate3.0Hemihydrate4.0Hemihydrate5.0Hemihydrate6.0Hemihydrate7.0Hemihydrate8.0Hemihydrate9.0Hemihydrate9.5Monohydrate1.0Monohydrate2.0Monohydrate3.0Monohydrate4.0Monohydrate5.0Monohydrate6.0Monohydrate7.0Monohydrate8.0Monohydrate9.0Monohydrate9.5

After a few days to weeks, the symptoms ameliorate.

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Abstract

The present invention relates to a method for treating a patient suffering from a thermoregulatory dysfunction, especially hot flashes and flushes associated with hormonal changes due to naturally occurring menopause (whether male or female) or due to chemically or surgically induced menopause. The method is also applicable to treating the hot flashes, hot flushes, or night sweats associated with disease states that disrupt normal hormonal regulation of body temperature.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]Not ApplicableSTATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT[0002]Not ApplicableFIELD OF THE INVENTION[0003]The present invention relates to a method for treating a patient suffering from a thermoregulatory dysfunction, especially hot flashes and flushes associated with hormonal changes due to naturally occurring menopause (whether male or female) or due to chemically or surgically induced menopause. The method is also applicable to treating the hot flashes, hot flushes, or night sweats associated with disease states that disrupt normal hormonal regulation of body temperature. The invention further relates to use of paroxetine or a salt thereof.BACKGROUND OF THE INVENTION[0004]Hot flashes or flushes are most typically seen in women who are in the process of going through menopause, but are also seen in women who have undergone surgical or chemically induced menopause. They are also seen (less frequently) in men who are un...

Claims

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Application Information

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IPC IPC(8): A61K31/137
CPCA61K31/4525A61P5/24A61P15/12A61K31/445A61K31/36
Inventor RICHARDS, PATRICIA ALLISON TEWES
Owner NOVEN THERAPEUTICS
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