Abilify Maintena 960 mg (aripiprazole) approved in the EU as the first once-every-two-months long-acting injectable for the maintenance treatment of schizophrenia
Otsuka Pharmaceutical Europe Ltd. and H. Lundbeck A/S announced that the European Commission (EC) has approved Abilify Maintena 960 mg (aripiprazole) as a once-every-two-months long-acting injectable (LAI) formulation for the maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole.
The EC decision applies to all European Union (EU) member states, as well as Iceland, Norway and Liechtenstein.
Aripiprazole once-every-two-months LAI is a new formulation containing 960 mg aripiprazole provided in a single-chamber prefilled syringe that does not require reconstitution. It is intended for dosing once every two months via intramuscular injection into the gluteal muscle1 and is the first once-every-two-months LAI antipsychotic licensed in the EU for this indication.
The EC based its approval on a 32-week pharmacokinetic bridging trial, which also evaluated the safety and efficacy of the drug as primary and secondary endpoint respectively1. Aripiprazole once-every-two-months LAI was shown to provide similar plasma concentrations, and therefore similar effectiveness, as well as a similar safety and tolerability profile to aripiprazole once-monthly LAI (Abilify Maintena 400 mg) in 266 adults, of whom 185 were diagnosed with schizophrenia.
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