Abilify Maintena is presented as powder in a vial which is reconstituted to provide a 400mg prolonged-release suspension for injection. The recommended dose is 400mg by intramuscular injection into the gluteal muscle once monthly (no sooner than 26 days after the previous injection).
The efficacy of aripiprazole 400mg given once monthly by intramuscular injection was compared with that of oral aripiprazole (10-30mg daily) and aripiprazole 50mg given intramuscularly once monthly in a 38-week double-blind study involving 662 patients (randomised population) with schizophrenia requiring chronic treatment with an antipsychotic.
Aripiprazole 400mg injected once monthly was found to be non-inferior to oral aripiprazole and was also shown to significantly reduce the rate of relapse and to delay the time to impending relapse compared with aripiprazole 50mg injected once monthly.
In another study, aripiprazole 400mg given once monthly by intramuscular injection for the maintenance treatment of schizophrenia (n=269) was shown to significantly delay time to impending relapse compared with placebo (n=134). In addition, improvements in total scores on the Clinical Global Impressions-Severity of Illness Scale and the Positive and Negative Syndrome Scale were maintained with aripiprazole monthly injection but worsened significantly with placebo.
Further information: Otsuka