Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Patent
1999-02-11
2000-09-19
Jarvis, William R. A.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
A61K 31445
Patent
active
061212911
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to the treatment and/or prevention of specific types of depression.
U.S. Pat. No. 4,007,196 discloses the compound, (-)-trans-4-(4'-fluorophenyl)-3-(3'4'-methylenedioxy-phenoxymethyl) piperidine, and, in Example 2, a process by which it can be prepared. The compound, which is referred to herein by its common name, paroxetine, is described in the patent as an inhibitor of 5-hydroxytryptamine uptake and, therefore, is of use in the treatment of depression in general.
It has now been surprisingly discovered that paroxetine has particularly effective therapeutic utility for treating and/or preventing specific types of depression.
Accordingly, the present invention provides a method for treating and/or preventing the following depression sub-types: adolescent, bipolar, elderly, major, minor, moderate, recurrent, refractory, severe unipolar, dysthymia, post natal, double depression, post psychotic, post viral, bereavement, primary, secondary, post traumatic stress disorder and depression associated with withdrawal from substances of abuse such as alcohol, nicotine, cocaine, heroin, benzodiazepines, in human or non-human animals, which method comprises administering an effective, non-toxic amount of paroxetine or a pharmaceutically acceptable salt thereof, to human or non-human animals in need thereof.
The present invention also provides the use of paroxetine or a pharmaceutically acceptable salt thereof in the manufacture of a medicament for use in the treatment of and/or prevention of the following depression sub-types: adolescent, bipolar, elderly, major, minor, moderate, recurrent, refractory, severe unipolar, dysthymia, post natal, double depression, post psychotic, post viral, bereavement, primary, secondary, post traumatic stress disorder and depression associated with withdrawal from substances of abuse such as alcohol, nicotine, cocaine, heroin, benzodiazepines,.
A preferred salt of paroxetine is the hydrochloride, particularly in crystalline form, such as the hemi-hydrate.
A medicament, for use in the treatment and/or prevention of the following depression sub-types: adolescent, bipolar, elderly, major, minor, moderate, recurrent, refractory, severe unipolar, dysthymia, post natal, double depression, post psychotic, post viral, bereavement, primary, secondary, post traumatic stress disorder and depression associated with withdrawal from substances of abuse such as alcohol, nicotine, cocaine, heroin, benzodiazepines, may be prepared by admixture of paroxetine or a pharmaceutically acceptable salt thereof with an appropriate carrier, which may contain a diluent, binder, filler, disintegrant, flavouring agent, colouring agent, lubricant or preservative in conventional manner.
Preferably, the medicament is in unit dosage form and in a form adapted for use in the medical or veterinarial fields. For example, such preparations may be in a pack form accompanied by written or printed instructions for use as an agent in the treatment and/or prevention of the following depression sub-types: adolescent, bipolar, elderly, major, minor, moderate, recurrent, refractory, severe unipolar, dysthymia, post natal, double depression, post psychotic, post viral, bereavement, primary, secondary, post traumatic stress disorder and depression associated with withdrawal from substances of abuse such as alcohol, nicotine, cocaine, heroin, benzodiazepines.
The suitable dosage range for paroxetine or a pharmaceutically acceptable salt depends on the severity of the disorders and on the condition of the patient. It will also depend, inter alia, upon the relation of potency to absorbability and the frequency and route of administration.
Paroxetine or a pharmaceutically acceptable salt thereof may be formulated for administration by any route, and examples are oral, rectal, topical, parenteral, intravenous or intramuscular administration. Preparations may, if desired, be designed to give slow release of the paroxetine or a pharmaceutically acceptable salt thereof.
The medicaments may, for example, be in t
REFERENCES:
patent: 4007196 (1977-02-01), Christensen et al.
patent: 5789449 (1998-08-01), Norden
Nemeroff, Biological Abstracts, abstract No. 1994:231203.
Duboff, Biological Abstracts, abstract No. 1994:120027, 1993.
Caley et al, Biological Abstracts, abstract No. 1994:23694, 1993.
Claghorn, Biological Abstracts, abstract No. 1992:239102.
Dustman Wayne J.
Jarvis William R. A.
King William T.
Kinzing Charles M.
SmithKline Beecham Plc
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