Groundbreaking LAI Antipsychotic Now Stands Approved In EU

It is indeed worth noting the fact that the first once-every-two-months long-acting injectable- LAI antipsychotic, given a nod by the European Commission- EC is authorized as a maintenance treatment when it comes to adults with schizophrenia in the EU.

The European Commission’s decision pertaining to the formulation of Abilify Maintena® 960 mg-aripiprazole happens to be applicable to all the EU Member States and also to Iceland, Norway, as well as Liechtenstein. Otsuka Pharmaceutical Europe Ltd. as well as H. Lundbeck A/S went on to underscore that the new LAI formulation gets provided in a single-chamber prefilled syringe in case of an intramuscular injection that does not require reconstitution.

Clinical evidence when it comes to the long-acting injectable- LAI

Data from one of the clinical studies in 266 adults has demonstrated that the long-acting injectable goes on to offer similar effectiveness and a similar safety and tolerability profile to aripiprazole once-monthly LAI- Abilify Maintena 400mg. There happened to be 185 participants diagnosed with schizophrenia across the trial.

This fresh approval happens to be based on data from a 32-week pharmacokinetic bridging trial. In the research, the safety as well as the efficacy of the treatment were assessed as primary and secondary endpoints, respectively, which the companies confirmed.

Importance of the EC approval

Authorization when it comes to this formulation of aripiprazole by the European Commission happens to be a significant milestone when it comes to adults with schizophrenia, as per Dr. Peter Gillberg, who happens to be the Vice President and Head of Medical Affairs with Otsuka Europe.

Especially designed for adult patients having schizophrenia who have got stabilised  with aripiprazole, this treatment looks forward to increasing patient adherence as well as convenience, said the Executive Vice President and Head of Research & Development at Lundbeck, Dr. Johan Luthman.

Abilify® (aripiprazole)

As per Otsuka Europe, Lundbeck A/S, and the European Medicines Agency- EMA, Abilify (aripiprazole) happens to be a dopamine D2 partial agonist as well as a 5-HT1A partial agonist and also a 5-HT2A receptor having antagonistic activity.

Based upon the product information from EMA, the treatment happens to be available as:

  • Everyday oral tablet
  • Tablet that’s orally disintegrating
  • Oral solution in the form of Abilify
  • Once-monthly long-acting injectable formulation, which is Abilify Maintena 400mg
  • Short-acting intramuscular – IM injection