Title:
METHODS FOR DOSE INITIATION OF ARIPIPRAZOLE TREATMENTS
Document Type and Number:
WIPO Patent Application WO/2021/201239
Kind Code:
A1
Abstract:
The present disclosure is directed to a method of dose initiation for an aripiprazole treatment to a patient in need thereof; the patient is administered two, separate 100 to 500 mg injections of an aripiprazole intramuscular (IM) depot formulation at separate gluteal and/or deltoid injection sites, and a single dose of oral aripiprazole. The administration occurs on a first day of the treatment.
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Inventors:
HARLIN MATTHEW (JP)
WANG XIAOFENG (JP)
WANG YANLIN (JP)
RAOUFINIA ARASH (JP)
WANG XIAOFENG (JP)
WANG YANLIN (JP)
RAOUFINIA ARASH (JP)
Application Number:
PCT/JP2021/014194
Publication Date:
October 07, 2021
Filing Date:
April 01, 2021
Export Citation:
Assignee:
OTSUKA PHARMA CO LTD (JP)
International Classes:
A61K31/496; A61P25/18
Foreign References:
| US20190099494A1 | 2019-04-04 | |||
| US20150087654A1 | 2015-03-26 | |||
| US202063003544P | 2020-04-01 | |||
| US7807680B2 | 2010-10-05 | |||
| US8030313B2 | 2011-10-04 | |||
| US8338427B2 | 2012-12-25 | |||
| US8338428B2 | 2012-12-25 | |||
| US8399469B2 | 2013-03-19 | |||
| US8722679B2 | 2014-05-13 | |||
| US8759351B2 | 2014-06-24 | |||
| US8993761B2 | 2015-03-31 | |||
| US9089567B2 | 2015-07-28 | |||
| US10525057B2 | 2020-01-07 |
Other References:
MARJIE L. HARD ET AL: "Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model", CNS DRUGS, vol. 31, no. 7, 8 June 2017 (2017-06-08), AUCKLAND, NZ, pages 617 - 624, XP055590498, ISSN: 1172-7047, DOI: 10.1007/s40263-017-0447-7
LESLIE CITROME: "Aripiprazole long-acting injectable formulations for schizophrenia: aripiprazole monohydrate and aripiprazole lauroxil", EXPERT REVIEW OF CLINICAL PHARMACOLOGY 20141101 EXPERT REVIEWS LTD. GBR, vol. 9, no. 2, 19 December 2015 (2015-12-19), UK, pages 169 - 186, XP055398416, ISSN: 1751-2433, DOI: 10.1586/17512433.2016.1121809
MARJIE L. HARD ET AL: "Pharmacokinetic Evaluation of a 1-Day Treatment Initiation Option for Starting Long-Acting Aripiprazole Lauroxil for Schizophrenia :", JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY., vol. 38, no. 5, 1 October 2018 (2018-10-01), US, pages 435 - 441, XP055590436, ISSN: 0271-0749, DOI: 10.1097/JCP.0000000000000921
WANG X ET AL: "P.533 The two-injection start of aripiprazole once-monthly provides rapid attainment of therapeutic concentrations without the need for 14-day oral tablet supplementation", EUROPEAN NEUROPSYCHOPHARMACOLOGY, ELSEVIER SIENCE PUBLISHERS BV , AMSTERDAM, NL, vol. 40, 1 November 2020 (2020-11-01), XP086353709, ISSN: 0924-977X, [retrieved on 20201117], DOI: 10.1016/J.EURONEURO.2020.09.388
LESLIE CITROME: "Aripiprazole long-acting injectable formulations for schizophrenia: aripiprazole monohydrate and aripiprazole lauroxil", EXPERT REVIEW OF CLINICAL PHARMACOLOGY 20141101 EXPERT REVIEWS LTD. GBR, vol. 9, no. 2, 19 December 2015 (2015-12-19), UK, pages 169 - 186, XP055398416, ISSN: 1751-2433, DOI: 10.1586/17512433.2016.1121809
MARJIE L. HARD ET AL: "Pharmacokinetic Evaluation of a 1-Day Treatment Initiation Option for Starting Long-Acting Aripiprazole Lauroxil for Schizophrenia :", JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY., vol. 38, no. 5, 1 October 2018 (2018-10-01), US, pages 435 - 441, XP055590436, ISSN: 0271-0749, DOI: 10.1097/JCP.0000000000000921
WANG X ET AL: "P.533 The two-injection start of aripiprazole once-monthly provides rapid attainment of therapeutic concentrations without the need for 14-day oral tablet supplementation", EUROPEAN NEUROPSYCHOPHARMACOLOGY, ELSEVIER SIENCE PUBLISHERS BV , AMSTERDAM, NL, vol. 40, 1 November 2020 (2020-11-01), XP086353709, ISSN: 0924-977X, [retrieved on 20201117], DOI: 10.1016/J.EURONEURO.2020.09.388
Attorney, Agent or Firm:
YAMAO, Norihito et al. (JP)
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