Otsuka Pharmaceutical Co., Ltd.
Otsuka And Lundbeck Receive Postive Chmp Opinion In Europe For Abilify Maintena™, A Once-Monthly Injectable For Schizophrenia
- If approved by the European Commission, Abilify Maintena™would become the only dopamine D2 partial agonist in once-monthly, injectable form for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.
- Reducing the risk of relapse is an important consideration in the treatment of patients with schizophrenia. Clinical trials demonstrated that Abilify Maintena reduced the risk of relapse in adult patients with schizophrenia in comparison with placebo.
- Approval of this new once-monthly formulation of aripiprazole in Europe will provide patients with schizophrenia with an effective and well-tolerated alternative treatment option.
(Tokyo, Japan and Copenhagen, Denmark, 20 September, 2013) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for Abilify Maintena (aripiprazole), an intramuscular (IM) depot formulation indicated for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.