Granted Patent
B2
US 12,691,056 · App. 19/352,541 · Granted Jul 28, 2026
Methods for dose initiation of aripiprazole treatments
Inventors:
Matthew Harlin (Severna Park, MD); Xiaofeng Wang (Ellicott City, MD); Yanlin Wang (Jersey City, NJ); Arash Raoufinia (Mclean, VA)
Assignee:
Otsuka Pharmaceutical Co., Ltd.
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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.
Claims (24)
1 . A method of administering an aripiprazole treatment to a patient in need thereof comprising:
administering a one-day dose initiation consisting of two, separate injections of an aripiprazole intramuscular (IM) depot formulation, wherein each injection comprises 300 mg or 400 mg of aripiprazole, to the patient at separate injection sites chosen from gluteal sites, deltoid sites, and a gluteal site and a deltoid site, and a single dose of oral aripiprazole ranging from about 2 mg to about 30 mg of aripiprazole, wherein the step of administering the two separate injections and the single oral dose occurs on a first day of the treatment,
wherein the patient has schizophrenia or bipolar I disorder, and
wherein the aripiprazole intramuscular (IM) depot formulation comprises aripiprazole monohydrate.
2 . The method according to claim 1 , wherein the patient in need of the aripiprazole treatment is a patient with or without prior stabilization on oral aripiprazole.
3 . The method according to claim 1 , wherein the patient in need of the aripiprazole treatment is a patient with prior stabilization on oral aripiprazole.
4 . The method according to claim 1 , wherein each of the two, separate injections comprise 400 mg of aripiprazole.
5 . The method according to claim 1 , wherein each of the two, separate injections comprise 300 mg of aripiprazole.
6 . The method according to claim 1 , further comprising after the first day of treatment, administering a single monthly, maintenance injection of the aripiprazole IM depot formulation comprising 400 mg of aripiprazole.
7 . The method according to claim 1 , further comprising after the first day of treatment, administering a single monthly, maintenance injection of the aripiprazole IM depot formulation comprising 300 mg of aripiprazole.
8 . The method according to claim 1 , wherein when the patient is a CYP2D6 poor metabolizer or is taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for greater than 14 days, the aripiprazole treatment comprises administering the single monthly, maintenance injections chosen from 160 mg and 200 mg of aripiprazole in the aripiprazole IM depot formulation.
9 . The method according to claim 1 , further comprising after the first day of treatment, administering a single monthly, maintenance injection wherein each maintenance injection is administered no sooner than 26 days after the previous injection.
10 . The method according to claim 1 , wherein the two, separate injections of the aripiprazole IM depot formulation are administered at separate gluteal and/or deltoid injection sites of the patient.
11 . The method according to claim 1 , wherein the two, separate injections of the aripiprazole IM depot formulation are administered at separate gluteal injection sites of the patient.
12 . The method according to claim 1 , wherein the two, separate injections of the aripiprazole IM depot formulation are administered at a gluteal injection site and a deltoid injection site of the patient.
13 . The method according to claim 1 , wherein the two, separate injections of the aripiprazole IM depot formulation are administered at separate deltoid injection sites of the patient.
14 . The method according to claim 1 , wherein the patient has schizophrenia.
15 . The method according to claim 1 , wherein the patient has bipolar I disorder.
16 . The method according to claim 1 , wherein the single dose of oral aripiprazole ranges from about 2 mg to about 30 mg of aripiprazole.
17 . The method according to claim 16 , wherein the single dose of oral aripiprazole ranges from about 10 mg to about 30 mg.
18 . The method according to claim 16 , wherein the single dose of oral aripiprazole is 20 mg.
19 . The method according to claim 16 , wherein the single dose of oral aripiprazole is 10 mg.
20 . The method according to claim 1 , wherein when the patient is a CYP2D6 poor metabolizer, each of the two, separate injections comprises about 300 mg of aripiprazole and the single dose of oral aripiprazole is about 20 mg.
21 . The method according to claim 1 , wherein the aripiprazole is in the form of a salt.
Continuity (3)
Provisional Application
63003544
· Apr 1, 2020
Related Publication
20260034053A1
· Feb 5, 2026
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