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Japan : Otsuka and Lundbeck's once-monthly Abilify MaintenaA (aripiprazole) now approved in Europe for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.

H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced marketing authorisation approval from the European Commission for Abilify Maintena (aripiprazole), an intramuscular (IM) once-monthly injectable formulation for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.

Abilify Maintena reduces the risk of relapse relative to placebo over the long-term and provides effective treatment of schizophrenia.1,2 It has a tolerability profile similar to oral aripiprazole1, and demonstrated statistically significant benefits on patients' personal and social functioning as compared to placebo.1, 4

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.4

"We strongly believe the schizophrenia community will welcome the availability of Abilify Maintena to help improve outcomes for patients living with schizophrenia. As a company, our focus is to develop treatments to help protect against relapse and preserve brain function," said Ole Vahlgren, CEO & President, Otsuka Europe. "We must partner with health care professionals and caregivers to help patients get the best treatments that focus on reducing the risk of relapse."

"Studies have shown that the early use of long-acting injectables can prevent a person with schizophrenia from experiencing a relapse5," said Ole Chrintz, SVP International Markets & Europe, Lundbeck. "Efficacy is important, but a treatment for a chronic condition such as schizophrenia also needs to be well tolerated so patients will stay on it over the long-term. We believe Abilify Maintena meets this need."1,2,3

About the studies

The efficacy of Abilify Maintena was demonstrated in two double-blind, phase III, randomized trials. The safety profile for Abilify Maintena was demonstrated to be similar to that of oral ABILIFY. The most frequently observed adverse drug reactions (ADRs) reported in ?5% of patients in two double-blind controlled clinical trials of Abilify Maintena were weight increases (9.0%), akathisia (7.9%), insomnia (5.8%), and injection site pain (5.1%).1,2

About Abilify Maintena

Abilify Maintena is the only dopamine D2 partial agonist in once-monthly, injectable form to receive marketing authorisation for maintenance treatment in schizophrenia. Physicians now have an alternative treatment option, with a tolerability profile comparable to the well-established oral ABILIFY, to address the on-going need to reduce the risk of relapse in patients with schizophrenia.

The European label states that Abilify Maintena is a powder and solvent for prolonged-release suspension for intra-muscular (IM) injection. It is a once-monthly formulation of aripiprazole in a sterile lyophilised powder that is reconstituted with sterile water.

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Publication:Mena Report
Date:Nov 22, 2013
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