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Lundbeck and Otsuka Pharmaceutical have announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use ( CHMP ) recommending marketing authorisation for Abilify Maintena ( Aripiprazole ), an intramuscular depot formulation for the maintenance treatment of schizophrenia in adult patients stabilised with oral Aripiprazole.

The pharmacological properties of Aripiprazole are mediated through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and antagonism at serotonin 5-HT2A receptors.
Abilify Maintena is a once-monthly injectable form of Aripiprazole that has already received regulatory approval in the United States ( USA ). It represents an alternative treatment option to address the need to reduce the risk of relapse ( relative to placebo ) in patients with schizophrenia.

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. Patients are previously stabilised with oral Aripiprazole.

The efficacy of Abilify Maintena was demonstrated in two double-blind, randomised phase III trials over 38 and 52 weeks respectively. In the primary pivotal trial analysis of the primary efficacy endpoint, the proportion of patients experiencing impending relapse by the end of week 26, demonstrated non-inferiority of Abilify Maintena to oral Aripiprazole and superiority to a sub-therapeutic dose of Aripiprazole once monthly. The key secondary endpoint, time to relapse, supported the efficacy in maintenance treatment.

In the second efficacy trial, Abilify Maintena significantly delayed time to relapse compared to placebo ( primary efficacy endpoint ). In a key secondary endpoint, the percentage of subjects experiencing relapse was also significantly lower with Abilify Maintena compared to placebo at the end of the study.

The safety profile for Abilify Maintena was comparable to oral Abilify.The most common side effects are weight gain, akathisia, insomnia, injection site pain.

Schizophrenia is a disease characterized by a distortion in the process of thinking and of emotional responsiveness. It most commonly manifests as hallucinations, paranoid or bizarre delusions, or disorganized speech and thinking, and is accompanied by significant social or occupational dysfunction. Onset of symptoms typically occurs in young adulthood, and the condition is chronic, often requiring life-long treatment to mitigate symptoms.
While there is no cure for the disease, symptoms and risk of relapse can be managed in most patients with appropriate antipsychotic treatment. However, when the disease is not managed, patients are at increased risk of disease relapse, which can cause the re-emergence or worsening of psychotic symptoms.
It has been estimated that schizophrenia affects approximately 1% of the adult population in the US and Europe, and approximately 24 million people worldwide. In the US, there are approximately 2.4 million adults with schizophrenia, prevalent equally in both genders. ( Xagena )


Source: Lundbeck, 2013

XagenaMedicine2013