Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced that the Committee for Medicinal Products for Human Use (CHMP) on 26th March issued a positive opinion (approval in EU) for the new pre-filled dual chamber syringe kit to administer Abilify Maintena for the maintenance treatment of schizophrenia.

The dual chamber pre-filled syringe is a new addition to the Abilify Maintena offering. Reconstitution occurs within the pre-filled dual chamber syringe, in a single step, which allows for easier handling. This product enhancement offers another option to simplify delivery of care to patients with schizophrenia and provides healthcare professionals with an easier-to-use option.

CHMP positive opinion (approval in EU) of the dual chamber kit follows the recent approval of the deltoid muscle as a new injection site for Abilify Maintena, the latter approval providing patients with a wider range of treatment options.

These new additions to Abilify Maintena are expected to be available for use later in the year.

Abilify Maintena is the first commercialised product in Europe from the global alliance between Otsuka and H. Lundbeck A/S (Lundbeck). Abilify Maintena is the only long-acting injectable (LAI) antipsychotic that exerts partial agonist activity at the D2 dopamine receptor. It provides physicians with an alternative treatment option, with a tolerability profile comparable to the well-established oral Abilify (aripiprazole), to address the ongoing need to protect patients with schizophrenia from relapse.

Abilify Maintena is a once-monthly formulation of aripiprazole in a sterile lyophilised powder that is reconstituted with sterile water. After the first injection, treatment with 10 mg to 20 mg oral aripiprazole should be continued for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy.

In Europe, Abilify Maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole. Abilify Maintena is available in a number of European countries and is progressing through the various healthcare authorities that provide access to patients. Abilify Maintena was approved by the US FDA in 2013 for the treatment of schizophrenia and includes the treatment of acutely relapsed adult patients with schizophrenia. It subsequently received marketing authorisations for the maintenance treatment of schizophrenia in stabilised adult patients in Canada, for the maintenance of clinical improvement in the treatment of schizophrenia in Australia, and for the maintenance treatment of schizophrenia in stabilised adult patients in Japan.

Otsuka and Lundbeck established a global alliance in November 2011 to bring to bear their considerable experience and resources in the CNS area to introduce next-generation treatments for conditions such as schizophrenia, depression, Alzheimer’s disease and alcohol dependency.