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93% of patients treated with Abilify Maintena were extremely, very or somewhat satisfied with their treatment at the end of the double-blind treatment phase.
We strongly believe the schizophrenia community will welcome the availability of Abilify Maintena to help improve outcomes for patients living with schizophrenia.
The efficacy of Abilify Maintena was demonstrated in two double-blind, phase III, randomized trials.
Abilify Maintena is the only dopamine D2 partial agonist in once-monthly, injectable form to receive marketing authorisation for maintenance treatment in schizophrenia.
Efficacy was demonstrated in a 52-week, placebo-controlled, double-blind, randomized-withdrawal, Phase 3 maintenance trial of ABILIFY MAINTENA in patients with schizophrenia.
ABILIFY MAINTENA is not approved for the treatment of patients with dementia-related psychosis.
Results from the clinical trial of ABILIFY MAINTENA were published in the Journal of Clinical Psychiatry and first presented in four poster presentations at the 2012 American Psychiatric Association Annual Meeting in May 2012.
Patients in the study received injections of ABILIFY MAINTENA or placebo once every four weeks; the first injection was accompanied by two weeks of concomitant administration of oral aripiprazole.
The benefits with Abilify Maintena are its ability to reduce the proportion of stabilised patients experiencing relapse in long term use and its properties to act as long acting agent, allowing a monthly administration instead of a daily oral intake of aripiprazole.
I am delighted that we now have a positive opinion for Abilify Maintena from the CHMP and if approved will be able to provide European patients with a long-term maintenance option for schizophrenia," said Ole Vahlgren, CEO & President, Otsuka Europe.
The efficacy of Abilify Maintena was demonstrated in two double-blind, randomised phase III trials over 38 and 52 weeks respectively.
In the second efficacy trial, Abilify Maintena significantly delayed time to relapse compared to placebo (primary efficacy endpoint)2.