Abilify Maintena
Psychiatry· 202 cited findings· 1 source document
Company: Otsuka Holdings Co., Ltd.
What the regulatory reviews say
Abilify Maintena is indicated for the maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. The Marketing Authorisation application was submitted on 30 November 2012, and a CHMP positive opinion was issued on 19 September 2013.
In efficacy studies, the estimated proportion of subjects with impending relapse by week 26 was 7.10% for Aripiprazole IM depot 400/300 mg, compared to 9.24% for Oral Aripiprazole 10-30 mg. The difference in estimated proportion of subjects with impending relapse by week 26 between Aripiprazole IM depot 400/300 mg and Oral Aripiprazole 10-30 mg was -2.14%. The non-inferiority margin used in trials was 11.5%. The proportion of responders at endpoint was 89.8% for the aripiprazole IM depot 400 mg/300 mg group and 89.4% for the oral aripiprazole 10-30 mg group.
Safety findings include injection site pain at 5.1%, akathisia events at 8.2%, and incidence of Parkinsonism events ranging from 3.0% to 6.9%. The incidence of leukopenia-related events was 2.3%.
Key figures — cited to the source page
| Estimated proportion of subjects with impending relapse by week 26 (Aripiprazole IM depot 400/300 mg) | 7.10 | Otsuka Holdings Co., Ltd. — Abilify Maintena EMA EPAR public, p.42 |
| Estimated proportion of subjects with impending relapse by week 26 (Oral Aripiprazole 10-30 mg) | 9.24 | Otsuka Holdings Co., Ltd. — Abilify Maintena EMA EPAR public, p.42 |
| Difference in estimated proportion of subjects with impending relapse by week 26 (Aripiprazole IM depot 400/300 mg vs Oral Aripiprazole 10-30 mg) | -2.14 | Otsuka Holdings Co., Ltd. — Abilify Maintena EMA EPAR public, p.42 |
| Non-inferiority margin | 11.5 | Otsuka Holdings Co., Ltd. — Abilify Maintena EMA EPAR public, p.37 |
| Proportion of responders at endpoint (aripiprazole IM depot 400 mg/300 mg group) | 89.8 | Otsuka Holdings Co., Ltd. — Abilify Maintena EMA EPAR public, p.43 |
| Injection site pain | 5.1% | Otsuka Holdings Co., Ltd. — Abilify Maintena EMA EPAR public, p.55 |
| Akathisia events | 8.2% | Otsuka Holdings Co., Ltd. — Abilify Maintena EMA EPAR public, p.57 |
| Incidence of Parkinsonism events | 6.9% | Otsuka Holdings Co., Ltd. — Abilify Maintena EMA EPAR public, p.65 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.