WO2005072742A1 - Treatment of psychoses with quetiapine antipsychotic - Google Patents

Treatment of psychoses with quetiapine antipsychotic Download PDF

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Publication number
WO2005072742A1
WO2005072742A1 PCT/SE2005/000094 SE2005000094W WO2005072742A1 WO 2005072742 A1 WO2005072742 A1 WO 2005072742A1 SE 2005000094 W SE2005000094 W SE 2005000094W WO 2005072742 A1 WO2005072742 A1 WO 2005072742A1
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WO
WIPO (PCT)
Prior art keywords
quetiapine
bipolar
patient
treatment
depression
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/SE2005/000094
Other languages
English (en)
French (fr)
Inventor
Brian Ault
Gilbert Block
Martin Brecher
Wayne Macfadden
Robin Mccoy
Margaret Minkwitz
Jamie Mullen
Ellis Wilson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
AstraZeneca AB
Original Assignee
AstraZeneca AB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by AstraZeneca AB filed Critical AstraZeneca AB
Priority to BRPI0507086-4A priority Critical patent/BRPI0507086A/pt
Priority to EP05704762A priority patent/EP1713488A1/en
Priority to JP2006550998A priority patent/JP2007520488A/ja
Priority to AU2005209142A priority patent/AU2005209142A1/en
Publication of WO2005072742A1 publication Critical patent/WO2005072742A1/en
Priority to IL176999A priority patent/IL176999A0/en
Anticipated expiration legal-status Critical
Priority to NO20063856A priority patent/NO20063856L/no
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/554—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having at least one nitrogen and one sulfur as ring hetero atoms, e.g. clothiapine, diltiazem
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/22—Anxiolytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants

Definitions

  • the present invention relates to methods using a dibenzothiazepine antipsychotic.
  • the bipolar disorders are mood disorders in which a disturbance in mood is the predominant feature.
  • Bipolar I disorder is characterized by one or more manic or mixed episodes, usually accompanied by major depressive episodes.
  • Bipolar II disorder is characterized by one or more major depressive episodes accompanied by at least one hypomanic episode.
  • Bipolar depression refers to the major depressive episodes that occur with bipolar I and II disorder.
  • the prevalence of bipolar disorder is estimated to be 1 to 3.5%, evenly divided between men and women. The length of time between onset and symptoms and proper diagnosis and treatment is approximately 10 years. It is estimated that only 60% of those suffering from a bipolar disorder are receiving appropriate pharmacotherapy.
  • the antiepileptic lamotrigine produced improvement in HAM-D and MADRS scores in a 7-week, double-blind, placebo controlled trial for the patients who completed this study (Calabrese 1999). More recently, the anti-manic agent divalproex demonstrated numerical improvement over placebo in the percentage of patients with bipolar depression having a 50% reduction in the HAM-D scores without mania in an 8 week trial (Sachs, , 2001) but this difference was not statistically significant. Lithium carbonate, also approved for the treatment of mania, has been demonstrated to be effective as a monotherapeutic agent in approximately 50% of patients with bipolar depression (Bauer). However, there are limitations to the use of the above therapies.
  • Quetiapine fumarate is described in U.S. Patent Number 4,879,288, which is incorporated herein by reference.
  • Quetiapine fumarate is a dibenzothiazepine derivative and is designated chemically as 2-[2-(4-dibenzo [b,f] [l,4]thiazepin-l 1-yl-l- piperazinyl)ethoxy]-ethanol fumarate.
  • applicants have reached surprising results that indicate the success of quetiapine in treating depression states. Recent clinical studies have revealed previously unrecognized pharmacological properties which suggest that quetiapine is useful in treating depression associated with bipolar disorder.
  • quetiapine was found to be well-tolerated in the treatment of bipolar depression with a low incidence of EPS (extrapyramidal symptoms), prolactin, sexual dysfunction and weight gain. Additionally, quetiapine was not associated with treatment-emergent mania in the treatment of bipolar depression and treatment resulted in a low rate of treatment-emergent mania. It has now been discovered that quetiapine or a pharmaceutically acceptable salt thereof is an effective treatment of the depression symptoms associated with one or more mood disorders. Certain embodiments of the invention include a method for treating depression symptoms associated with one or more mood disorders comprising administering to a patient a therapeutically effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a compound of Formula (I):
  • Certain embodiments of the method include the use of a compound of quetiapine or a pharmaceutically acceptable salt thereof, for the preparation of a medicament for treating depression symptoms associated with one or more mood disorders in a patient.
  • Other embodiments of the method include the use of a compound of quetiapine or a pharmaceutically acceptable salt thereof, for the preparation of a medicament for treating depression symptoms associated with bipolar disorder in a patient.
  • the present invention relates to a method for treating one or more mood disorders by administering quetiapine.
  • the structure of quetiapine is shown in Formula I:
  • One embodiment of the invention provides a method which comprises administering quetiapine or a pharmaceutically acceptable salt to a patient for the treatment of depression symptoms associated with one or more mood disorders. Another embodiment of the invention provides a method which comprises administering quetiapine fumarate to a patient for the treatment of depression symptoms associated with bipolar disorder. Another embodiment of the invention provides a method which comprises administering quetiapine fumarate to a patient for the treatment of depression symptoms associated with bipolar I disorder. Another embodiment of the invention provides a method which comprises administering quetiapine fumarate to a patient for the treatment of depression symptoms associated with bipolar II disorder.
  • Another embodiment of the invention provides a method which comprises administering quetiapine fumarate to a patient for the treatment of depression symptoms associated with bipolar depression.
  • the term "therapeutically effective amount” as used herein means an amount of the compound which is effective in treating the named disorder or condition.
  • bipolar depression may be treated by administering quetiapine to a patient in a dosage ranging from about 300 mg/day to about 600 mg/day.
  • quetiapine is more effective than placebo and well tolerated for the treatment of depressive episodes in patients with one or more mood disorders.
  • Applicants have further discovered that quetiapine is more effective than placebo and well tolerated for the treatment of depressive episodes in patients with bipolar depression.
  • quetiapine is more effective than placebo and well tolerated for the treatment of anxiety symptoms, reduced sleep quality and reduced quality of life in patients with bipolar disorder.
  • the following examples provided are not meant to limit the invention in any manner and are intended for illustrative purposes only.
  • EXAMPLES The results of a monotherapy study demonstrates the therapeutic value of the use of quetiapine fumarate in the treatment of patients with bipolar depression. Study The study was a multicenter, 8 week, double-blind, randomized, placebo-controlled, double-dummy trial of the use of quetiapine fumarate in the treatment of patients with bipolar depression conducted in 539 subjects with 511 patients in ITT population. The treatment was with quetiapine or placebo.
  • Week 4 ( ⁇ ) 11.0(10.7)* 8.6 (9.6) a 6.0 (9.2) Week 8 ( ⁇ ) 16.3 (10.3)* 11.7 (10.4) a 8.9(10.1) Week 8 ( ⁇ ) LOCF 12.2(11.6)* 10.2 (10.7)* 6.8(10.0)
  • Week 4 ( ⁇ ) -5.3 (4.9)* -4.7 (4.2)* -2.5 (4.2)
  • Week 8 ( ⁇ ) -6.4 (4.3)* -5.3 (4.3)* -3.8(4.1)
  • Week 8 ( ⁇ ) LOCF -5.5 (4.8)* -5.1 (4.3)* -3.0 (4.2)
  • Treatment-Emergent Mania Criteria for Emergent Mania (any one of the following): AE (Adverse Event) or SAE (Serious Adverse Event) of Mania. Withdrawal for AE of mania. YMRS (Young Mania Rating Scale) > 16 on 2 consecutive or final assessment.
  • Quetiapine was found to also exhibit efficacy in a broad range of symptom domains in bipolar depression, including anxiety and reduction in sleep quality.

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  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Anesthesiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen- Or Sulfur-Containing Heterocyclic Ring Compounds With Rings Of Six Or More Members (AREA)
  • Hydrogenated Pyridines (AREA)
PCT/SE2005/000094 2004-01-30 2005-01-27 Treatment of psychoses with quetiapine antipsychotic Ceased WO2005072742A1 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
BRPI0507086-4A BRPI0507086A (pt) 2004-01-30 2005-01-27 método para tratar sintomas de depressão, método monoterapêutico para tratar um paciente quanto aos sintomas de depressão, e, uso de um composto de quetiapina ou um seu sal farmaceuticamente aceitável
EP05704762A EP1713488A1 (en) 2004-01-30 2005-01-27 Treatment of psychoses with quetiapine antipsychotic
JP2006550998A JP2007520488A (ja) 2004-01-30 2005-01-27 クエチアピン抗精神病薬による精神病の治療
AU2005209142A AU2005209142A1 (en) 2004-01-30 2005-01-27 Treatment of psychoses with quetiapine antipsychotic
IL176999A IL176999A0 (en) 2004-01-30 2006-07-20 Treatment of psychoses with quetiapine antipsychotic
NO20063856A NO20063856L (no) 2004-01-30 2006-08-29 Behandling av psykoser med quetiapin-antipsykotiske midler

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US54061804P 2004-01-30 2004-01-30
US60/540,618 2004-01-30

Publications (1)

Publication Number Publication Date
WO2005072742A1 true WO2005072742A1 (en) 2005-08-11

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PCT/SE2005/000094 Ceased WO2005072742A1 (en) 2004-01-30 2005-01-27 Treatment of psychoses with quetiapine antipsychotic

Country Status (13)

Country Link
US (2) US20050171088A1 (https=)
EP (1) EP1713488A1 (https=)
JP (1) JP2007520488A (https=)
KR (1) KR20070011276A (https=)
CN (1) CN1913902A (https=)
AU (1) AU2005209142A1 (https=)
BR (1) BRPI0507086A (https=)
CA (1) CA2495361A1 (https=)
IL (1) IL176999A0 (https=)
NO (1) NO20063856L (https=)
RU (1) RU2006130687A (https=)
WO (1) WO2005072742A1 (https=)
ZA (1) ZA200606128B (https=)

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US7459469B2 (en) 2004-11-10 2008-12-02 Targacept, Inc. Hydroxybenzoate salts of metanicotine compounds
US8053451B2 (en) 2004-11-10 2011-11-08 Targacept, Inc. Hydroxybenzoate salts of metanicotine compounds
US8580826B2 (en) 2004-11-10 2013-11-12 Targacept, Inc. Hydroxybenzoate salts of metanicotine compounds
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NO20063856L (no) 2006-10-26
CN1913902A (zh) 2007-02-14
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US20050171088A1 (en) 2005-08-04
BRPI0507086A (pt) 2007-06-19
KR20070011276A (ko) 2007-01-24
RU2006130687A (ru) 2008-03-10
AU2005209142A1 (en) 2005-08-11
IL176999A0 (en) 2006-12-10

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