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Therapeutic combinations of atypical antipsychotics with corticotropin releasing factor antagonists

A technology of antipsychotic drugs and adrenal cortex, which can be used in drug combinations, nervous system diseases, and pharmaceutical formulations, and can solve problems such as side effects

Inactive Publication Date: 2007-02-21
PFIZER PRODS ETAT DE CONNECTICUT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Lithium, standard of care for mood disorders, only has a 50% response rate and comes with side effects

Method used

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  • Therapeutic combinations of atypical antipsychotics with corticotropin releasing factor antagonists
  • Therapeutic combinations of atypical antipsychotics with corticotropin releasing factor antagonists
  • Therapeutic combinations of atypical antipsychotics with corticotropin releasing factor antagonists

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0577] A pharmaceutical composition is prepared by combining ziprasidone with a CRF antagonist, either (a) 4-(1-ethyl-propoxy)-3,6 in a pharmaceutically acceptable carrier -Dimethyl-2-(2,4,6-trimethylphenoxy)-pyridine, (b) (3,6-dimethyl-2-(2,4,6-trimethyl-benzene Oxy)-pyridin-4-yl)-(1-ethyl-propyl)-amine, (c)(3,6-dimethyl-2-(4-chloro-2,6-dimethyl- Phenoxy)-pyridin-4-yl)-(1-ethyl-propyl)-amine, or (d) 5-(1-ethyl-propoxy)-7-methyl-1-( 2,6-Dimethyl-4-chlorophenyl)-1-4-dihydro-2H-3-oxa-1,8-naphthyridine. The composition comprises corresponding amounts of ziprasidone and CRF antagonist to provide about 20 mg to about 160 mg of ziprasidone and about 0.1 to 100 mg of CRF antagonist on a daily basis. The composition is administered to patients once a day, twice a day, three times a day or four times a day for treating schizophrenia.

Embodiment 2

[0579] Combination administration of ziprasidone and CRF antagonists

[0580] A prospective, open-label, randomized, scaled-dose multicentre study was performed comparing IM (intramuscular injection) with and without a CRF antagonist at the dose of CRF antagonist described in Example 1. ) Effectiveness of ziprasidone in improving anxiety and psychosis in patients with psychotic disorders. Ziprasidone is administered by intramuscular injection in doses of 10 or 20 mg, with additional daily doses up to a maximum of 40 mg if necessary.

[0581] About half of the ziprasidone-treated patients received at least one dose of the CRF antagonist of Example 1 during IM therapy. The primary efficacy outcome was the mean change from baseline in scores on the Brief Psychiatric Rating Scale (BPRS), CGI-S, and CGI-Improvement (CGI-I) scores. BPRS, CGI-S, and CGI-I were assessed every 24 hours during IM treatment and at baseline at the end of day 3.

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PUM

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Abstract

The present invention relates to a pharmaceutical composition comprising (a) an atypical antipsychotic drug, a prodrug thereof , or a pharmaceutically acceptable salt of the atypical antipsychotic drug or its prodrug; (b) a corticotropin releasing factor antagonist, a prodrug thereof, or the corticotropin releasing factor antagonist or its a pharmaceutically acceptable salt of the prodrug; and optionally (c) a pharmaceutically acceptable excipient, carrier or diluent. The present invention also relates to a method for treating one or more of the aforementioned disorders or conditions, said method comprising administering to a mammal in need of such treatment the aforementioned components (a) and (b ), wherein (a) and (b) are each optionally and independently administered together with a pharmaceutically acceptable excipient, carrier or diluent.

Description

technical field [0001] The present invention relates to an atypical antipsychotic drug, a prodrug thereof, or a pharmaceutically acceptable salt of the atypical antipsychotic drug or a prodrug thereof, and a corticotropin releasing factor antagonist, a prodrug thereof, or the adrenocorticotropic Combination pharmaceutical compositions of corticosteroid releasing factor antagonists or pharmaceutically acceptable salts of prodrugs thereof, kits comprising such combinations, and use of such combinations in the treatment of patients with treatment-resistant anxiety disorders, psychotic disorders or A method for a mammal, including a human, of a disorder, mood disorder or condition, or a combination thereof. The present invention also relates to an atypical antipsychotic drug, its prodrug, or a pharmaceutically acceptable salt of the atypical antipsychotic drug or its prodrug, and a corticotropin releasing factor antagonist, its prodrug, or the adrenocorticotropic hormone Additive...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/551A61K31/496A61K31/554A61K31/40A61K31/519A61K31/55A61K31/4178A61K31/44A61K31/4375A61K31/505A61K31/437A61K31/4985A61K45/06A61K31/425A61K31/416A61K31/4353A61K31/47
CPCA61K45/06A61K31/437A61K31/47A61K31/551A61K31/5513A61K31/519A61K31/4353A61K31/554A61K31/496A61K31/4985A61K31/44A61K31/4178A61K31/416A61K31/505A61K31/4375A61K31/425A61K31/55A61K31/40A61P25/00A61P25/18A61P25/20A61P25/24A61K2300/00A61K31/428
Inventor 史蒂文·约瑟夫·罗马诺
Owner PFIZER PRODS ETAT DE CONNECTICUT
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