Abilify/Abilify Maintena
Author: Stephanie Yip
Publisher: Datamonitor Healthcare
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Drug Overview
Abilify (aripiprazole; Otsuka/Lundbeck) is an atypical antipsychotic that contains aripiprazole, a partial agonist of dopamine receptor D2 and serotonin receptor 5-HT1A, and antagonist of the 5-HT2A receptor. Abilify’s partial agonist activity at the D2 receptors allows it to act as a dopamine stabilizer as it blocks overstimulated receptors and stimulates underactive ones. It is also thought to reduce the adverse events of stronger D2 blockade, particularly motor function side effects.
Otsuka Pharmaceutical initially launched Abilify in the US in 2002 for the treatment of schizophrenia, but the company subsequently pursued a number of bipolar disorder indications.
Abilify was originally co-marketed with Bristol-Myers Squibb. This agreement was terminated in the US in April 2015 and in the EU in June 2014. Otsuka Pharmaceutical is currently responsible for all marketing activities in the US and Japan. In the EU, the company marketed Abilify in partnership with Lundbeck for a period from 2013; however, this co-promotion is now limited to the long-acting injectable (LAI) formulation of aripiprazole.
Abilify Maintena is the LAI extension of the well-established Abilify franchise. While the product is related to the previous market leader Abilify, it does not match up to Abilify’s strong tolerability profile. Abilify Maintena is commonly associated with weight gain and akathisia, diminishing its clinical attractiveness.
CONTENTS
5 OVERVIEW
5 Drug Overview
6 Product Profiles
6 Abilify : Depression
16 Abilify : Bipolar disorder
30 Abilify : Schizophrenia
41 Abilify Maintena : Bipolar disorder
50 Abilify Maintena : Schizophrenia
LIST OF FIGURES
11 Figure 1: Datamonitor Healthcare’s drug assessment summary of Abilify for depression
12 Figure 2: Datamonitor Healthcare’s drug assessment summary of Abilify for depression
14 Figure 3: Abilify sales for depression across the US, Japan, and five major EU markets, by country, 2017–26
24 Figure 4: Abilify for bipolar disorder – SWOT analysis
25 Figure 5: Datamonitor Healthcare’s drug assessment summary for Abilify in bipolar disorder
26 Figure 6: Datamonitor Healthcare’s drug assessment summary for Abilify in bipolar disorder
34 Figure 7: Abilify for schizophrenia – SWOT analysis
35 Figure 8: Datamonitor Healthcare’s drug assessment summary of Abilify for schizophrenia
36 Figure 9: Datamonitor Healthcare’s drug assessment summary of Abilify for schizophrenia
38 Figure 10: Abilify sales for schizophrenia across the US, Japan, and five major EU markets, by country, 2017–26
45 Figure 11: Abilify Maintena for bipolar disorder – SWOT analysis
46 Figure 12: Datamonitor Healthcare’s drug assessment summary for Abilify Maintena in bipolar disorder
47 Figure 13: Datamonitor Healthcare’s drug assessment summary for Abilify Maintena in bipolar disorder
55 Figure 14: Abilify Maintena for schizophrenia – SWOT analysis
56 Figure 15: Datamonitor Healthcare’s drug assessment summary of Abilify Maintena for schizophrenia
57 Figure 16: Datamonitor Healthcare’s drug assessment summary of Abilify Maintena for schizophrenia
59 Figure 17: Abilify Maintena sales for schizophrenia across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
7 Table 1: Abilify drug profile
8 Table 2: Approval history of Abilify for depression in the US and Japan
9 Table 3: Late-phase trials of Abilify for depression
10 Table 4: Abilify for depression – SWOT analysis
17 Table 5: Abilify bipolar disorder indication approvals
18 Table 6: Abilify drug profile
20 Table 7: Overview of key clinical trial data for Abilify in bipolar disorder
23 Table 8: Commonly observed adverse reactions in clinical trials of Abilify in bipolar mania
31 Table 9: Abilify drug profile
32 Table 10: Abilify pivotal trial data in schizophrenia
39 Table 11: Abilify sales for schizophrenia across the US, Japan, and five major EU markets, by country ($m), 2017–26
41 Table 12: Abilify Maintena bipolar disorder indication approvals
42 Table 13: Abilify Maintena drug profile
43 Table 14: Overview of key clinical trial data for Abilify Maintena in bipolar disorder
44 Table 15: Commonly observed adverse reactions in clinical trials of Abilify Maintena in bipolar I disorder
50 Table 16: Abilify Maintena drug profile
52 Table 17: Abilify Maintena pivotal trial data in schizophrenia
55 Table 18: Abilify Maintena other late-phase clinical data in schizophrenia
60 Table 19: Abilify Maintena sales for schizophrenia across the US, Japan, and five major EU markets, by country ($m), 2017–26
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