The first once-every-two-months long-acting injectable (LAI) antipsychotic approved by the European Commission (EC) is authorised as maintenance treatment for adults with schizophrenia in the EU.
The European Commission’s decision for this formulation of Abilify Maintena® 960mg (aripiprazole) is applicable to all EU Member States, in addition to Iceland, Norway and Liechtenstein. Otsuka Pharmaceutical Europe Ltd and H Lundbeck A/S highlighted that the new LAI formulation is provided in a single-chamber prefilled syringe for intramuscular injection, which does not require reconstitution.
Clinical evidence for the long-acting injectable (LAI)
Data from a clinical study in 266 adults, has shown that the long-acting injectable offers similar effectiveness, as well as a similar safety and tolerability profile to aripiprazole once-monthly LAI (Abilify Maintena 400mg). There were 185 participants diagnosed with schizophrenia in the trial.
This new approval is based on data from a 32-week pharmacokinetic bridging trial. In the study, the safety and efficacy of the treatment was evaluated as primary and secondary endpoint respectively, the companies confirmed.
Significance of the EC approval
Authorisation of this formulation of aripiprazole by the European Commission is a “significant milestone” for adults with schizophrenia, according to Dr Peter Gillberg, Vice President and Head of Medical Affairs at Otsuka Europe.
“Specifically designed for adult patients with schizophrenia who have been stabilised with aripiprazole, this treatment aims to increase patient adherence and convenience,” Dr Johan Luthman, Executive Vice President and Head of Research & Development at Lundbeck commented.
Abilify® (aripiprazole)
According to Otsuka Europe, Lundbeck A/S and the European Medicines Agency (EMA), Abilify (aripiprazole) is a dopamine D2 partial agonist and 5-HT1A partial agonist and a 5-HT2A receptor with antagonistic activity.
Based on product information from the EMA, the treatment is available as a:
- daily oral tablet
- orally disintegrating tablet
- oral solution (Abilify)
- once-monthly long-acting injectable formulation (Abilify Maintena 400mg)
- short-acting intramuscular (IM) injection
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