Abilify/Abilify Maintena

  • ID: 4533533
  • Report
  • 61 pages
  • 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.
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OVERVIEW
Drug Overview
Product Profiles
Abilify: Bipolar disorder
Abilify: Schizophrenia
Abilify: Depression
Abilify Maintena: Bipolar disorder
Abilify Maintena: Schizophrenia

List of Figures
Figure 1: Abilify for bipolar disorder - SWOT analysis
Figure 2: Drug assessment summary for Abilify in bipolar disorder
Figure 3: Drug assessment summary for Abilify in bipolar disorder
Figure 4: Abilify for schizophrenia - SWOT analysis
Figure 5: Drug assessment summary of Abilify for schizophrenia
Figure 6: Drug assessment summary of Abilify for schizophrenia
Figure 7: Abilify sales for schizophrenia across the US, Japan, and five major EU markets, by country, 2017-26
Figure 8: Abilify for depression - SWOT analysis
Figure 9: Drug assessment summary for Abilify in depression
Figure 10: Drug assessment summary for Abilify in depression
Figure 11: Discontinuation rates due to adverse events in pivotal Phase III trials of adjunctive Abilify and Seroquel XR in MDD
Figure 12: Abilify Maintena for bipolar disorder - SWOT analysis
Figure 13: Drug assessment summary for Abilify Maintena in bipolar disorder
Figure 14: Drug assessment summary for Abilify Maintena in bipolar disorder
Figure 15: Abilify Maintena for schizophrenia - SWOT analysis
Figure 16: Drug assessment summary of Abilify Maintena for schizophrenia
Figure 17: Drug assessment summary of Abilify Maintena for schizophrenia
Figure 18: Abilify Maintena sales for schizophrenia across the US, Japan, and five major EU markets, by country, 2017-26

List of Tables
Table 1: Abilify bipolar disorder indication approvals
Table 2: Abilify drug profile
Table 3: Overview of key clinical trial data for Abilify in bipolar disorder
Table 4: Commonly observed adverse reactions in clinical trials of Abilify in bipolar mania
Table 5: Abilify drug profile
Table 6: Abilify pivotal trial data in schizophrenia
Table 7: Abilify sales for schizophrenia across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 8: Abilify drug profile
Table 9: Abilify pivotal trial data in depression
Table 10: Abilify Maintena bipolar disorder indication approvals
Table 11: Abilify Maintena drug profile
Table 12: Overview of key clinical trial data for Abilify Maintena in bipolar disorder
Table 13: Commonly observed adverse reactions in clinical trials of Abilify Maintena in bipolar I disorder
Table 14: Abilify Maintena drug profile
Table 15: Abilify Maintena pivotal trial data in schizophrenia
Table 16: Abilify Maintena other late-phase clinical data in schizophrenia
Table 17: Abilify Maintena sales for schizophrenia across the US, Japan, and five major EU markets, by country ($m), 2017-26
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