Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Patent
1999-09-07
2000-11-21
Jarvis, William R. A.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
514220, 514258, 514327, A61K 3155, A61K 31505, A61K 31445
Patent
active
061503533
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to therapeutic combinations of mirtazapine and an antipsychotic agent, to pharmaceutical compositions containing said combinations and to their use in the treatment or prophylaxis of psychotic disorders.
BACKGROUND OF THE INVENTION
The term antipsychotic agent includes those classical antipsychotics which work via dopamine D.sub.2 receptor blockade and which are often referred to as "typical" antipsychotics or neuroleptics, and those new antipsychotics which are referred to as "atypical" antipsychotic agents. This atypicality has been defined in a number of ways, but recently it has been defined as the property of providing equal efficacy to established antipsychotic agents while producing fewer extrapyramidal side effects (Meltzer H. Y. Br. J. Psychiatry, 1996, 168 Suppl. 129:23-31). Examples of such typical and atypical antipsychotics include acepromazine, chlorproethazine, chlorpromazine, cyamemazine fluopromazine, methotrimeprazine, promazine, mesoridazine, pericyazine, piperacetazine, pipothiazine, sulforidazine, thioridazine, acetophenazine, carphenazine, dixyrazine, fluphenazine, perazine, perphenazine, prochlorperazine thiopropazate, thioproperazine, trifluperazine, chlorprothixene, flupenthixol, thiothixene, zuclopenthixol, benperidol, bromperidol, droperidol, fluanisone, haloperidol, melperone, moperone, pipamperone, spiperone, timiperone, trifluperidol, fluspirilene, penfluridol, pimozide, amisulpride, raclopride, remoxipride, sulpiride, sultopride, tiapride, molindone, oxypertine, clozapine, loxapine, risperidone, olanzapine, sertindole, quetiapine and ziprasidone.
SUMMARY OF THE INVENTION
It has now been found that the administration of mirtazapine, which is one of the newest antidepressant agents and has been disclosed in U.S. Pat. No. 4,062,848, in combination with an antipsychotic agent is able to enhance the antipsychotic effect of said antipsychotic.
It is a feature of this invention that the use of such drug combinations will enhance the effect of the antipsychotic agent to be used and therefore allow reduced quantities of an antipsychotic agent to be used and furthermore, therefore allow better management of drug related toxicity and side effects.
Thus according to one aspect, the present invention provides a combination comprising mirtazapine and an antipsychotic agent as herein before described. Preferably the combination includes mirtazapine.
It will be understood that the present invention also includes derivatives of mirtazapine and the antipsychotic agents. Such derivatives include the pharmaceutically acceptable salts thereof. Suitable salts include acid addition salts, for example, hydrochloric, fumaric, maleic, citric or succinic acid, these acids being mentioned only by way of illustration and without implied limitation.
Combinations of mirtazapine and an antipsychotic agent may hereinafter be referred to as combinations according to the invention.
It will be appreciated that the compounds of the combination may be administered simultaneously, either in the same or different pharmaceutical formulation or sequentially. If there is sequential administration, the delay in administering the second active ingredient should not be such as to lose the benefit of the efficacious effect of the combination of the active ingredients.
The present invention further provides combinations according to the invention for use in therapy, more particularly in the treatment or prophylaxis of psychotic disorders such as schizophrenia, mania, hyperactivity, substance abuse, emesis and schizophreniaform disorders.
The present invention further includes a method for the treatment of an animal, for example, a mammal including a human, suffering from or liable to suffer from a psychotic disorder, including any of the aforementioned disorders, which comprises administering an effective amount of a combination according to the invention.
A further feature of the present invention is the method of reducing the amount of antipsychotic agent requir
REFERENCES:
Berendsen et al., Psychpharmacology, 135:3:pp. 284-89, 1998.
Gower et al., Arch. Int. Pharmacodyn. Ther., vol. 291, pp. 185-2011, 1988.
Neal-Beliveau et al., J. Pharm. Experim. Therap., vol. 265:1, pp. 204-217, 1993.
Biological Abstracts, vol. 84, ABstract No. 101722, 1987.
Barbhaiya et al., J. Clin. Psychopharm., vol. 16:1, pp. 26-34, 1996 1987.
Patent Abstracts of Japan, vol. 096, No. 1, JP 07 242669, 1995.
Balant-Gorgia et al., Therapie, vol. 51:4, pp. 399-402, 1996.
Berendsen Hermanus Henricus Gerardus
Broekkamp Christophorus Louis Eduard
Pinder Roger Martin
Akzo Nobel N.V.
Gormley Mary E.
Jarvis William R. A.
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