Compositions and methods for the control of smoking

Drug – bio-affecting and body treating compositions – Addiction – Tobacco

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Details

514 23, 530401, A61K 3135

Patent

active

058831371

DESCRIPTION:

BRIEF SUMMARY
This application is a 371 of PCT/AU95/00621filed on Sep. 21, 1995, which claims priority to Australian Application PM 8353, filed Sep. 23, 1994.
This invention is directed to compositions for use in the control of smoking, and methods which control or reduce the desire to smoke.
Cigarette smoking is recognized world wide as a health risk. Compared to non-smokers, there is a clear increase in morbidity and mortality across all age groups of cigarette smokers. Apart from well described negative effects upon asthma (J. Wakefield, (1988) Personality and Individual Differences, 9(2):465-477), clinical contact with smokers provides anecdotal data supporting the notion that smoking is associated with breathlessness, fatigue, or reduced fitness. These deleterious health effects of cigarette smoking have been widely publicized. It is reported that many smokers are convinced that smoking is indeed a health hazard (S. M. Glynn and S. Sussman, (1990) Hospital and Community Psychiatry 41(9): 1027-1028). Despite this conviction, approximately one adult in three continues to smoke (Australian Institute of Health and Welfare, (1992) The Third Biennial report of the AIHW, AGPS, Canberra).
Various proposals have been put forward for the control of smoking and for the treatment of withdrawal symptoms associated therewith. One proposal is the use of transdermal (or gum-delivered) nicotine as an anti-smoking therapy. This approach is based on the view that nicotine addiction is the primary chemical reason for smoking (see, for example, Australian Patent No 607214). Outcome studies have cast doubt upon the assumption that nicotine is the reason for smoking. Even when using a concomitant programme to treat the behavioural aspects of the smoking habit, the success of nicotine-based interventions are little better than placebo or psychological therapy alone (Buchkremer et al, (1991) Pharmacopsychiatry 24(3):96-102).
Hypnotism, acupuncture and other "natural therapies" have also been used for the control of smoking, again with little success.
There is accordingly a need for alternative treatments for the control of smoking.
In accordance with one aspect of this invention, there is provided a composition for, said the control of smoking composition comprising:
In accordance with another aspect of this invention, there is provided a method for the control of the desire to smoke, which comprises administering to a subject in need of such treatment a composition which comprises:
In another aspect this invention relates to the use of a composition comprising: manufacture of a medicament for the control of smoking.
In a still further aspect of this invention there is provided agents for the control of smoking, which agent comprises:
The compositions according to this invention have surprisingly been found to control smoking. Reference to the control of smoking includes suppression of the desire or need to smoke. This may in turn result in a substantial reduction in the number of cigarettes smoked by an individual, or may result in a cessation of smoking. The applicants do not wish to place any limitations on the mechanism of action of the compositions of the invention. Clinical results, as described herein, demonstrate that the compositions of the invention suppress the desire or need to smoke.
As mentioned above, the compositions according to this invention comprise:
The term "xanthine oxidase" as used herein will be understood to include xanthine dehydrogenase and xanthine oxidoreductase.
Xanthine oxidase inhibitors are well known in the art. The inhibitors block xanthine oxidase activity by a variety of mechanisms which include competitive inhibition (where the compounds act as antagonist), binding to xanthine oxidase at or near the active site thereby blocking enzymic activity, altering the conformation of the xanthine oxidase by binding to xanthine oxidase generally outside of the active site, binding or otherwise inactivating free radical agents produced by xanthine oxidase, or other mechanisms.
A first group of xanthine oxidase in

REFERENCES:
patent: 4997671 (1991-03-01), Spanier
patent: 5612357 (1997-03-01), Keenan et al.
patent: 5656255 (1997-08-01), Jones et al.
patent: 5721257 (1998-02-01), Baker et al.
JP 4-46119, Takeda Chem Ind Ltd(1), application No. 2-154348. Feb. 17, 1992

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