Otsuka Pharmaceutical Co., Ltd. and H Lundbeck has received the Notice of Compliance from the Health Canada for Abilify Maintena, an intramuscular (IM) once-monthly injectable formulation indicated for the maintenance treatment of schizophrenia in stabilized adult patients. Abilify Maintena will be the first commercialized product in Canada from the global alliance between Otsuka and Lundbeck, which is focused on developing Central Nervous System (CNS) therapies worldwide.
The companies expect the product will be available in Canada in April 2014.
Abilify Maintena is the only dopamine D2 partial agonist in once-monthly, injectable form to receive marketing authorization for maintenance treatment in schizophrenia. Abilify Maintena reduces the risk of relapse relative to placebo over the long-term and provides effective treatment of schizophrenia. In controlled clinical trials, Abilify Maintena was shown to be significantly superior in comparison to non-active treatments (placebo or pseudo-placebo) in the prevention of psychotic symptoms/impending relapse for up to 38 weeks after stabilization with oral aripiprazole. Further, efficacy was found to be comparable to that of oral aripiprazole with a similar tolerability profile. Efficacy was demonstrated through two pivotal trials: a 38-week, active-controlled trial to examine the proportion of subjects meeting impending relapse criteria and a 52-week, placebo-controlled trial, which examined the time to impending relapse. In the latter study, time to impending relapse was significantly delayed with Abilify Maintena compared with IM placebo (p < 0.0001; log rank test).
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.
OCPI, a part of the Otsuka Group, is an innovative, fast-growing health care company that commercializes Otsuka medicines in Canada, with a focus on commitment to neuroscience, cardiovascular, and oncology. OCPI is dedicated to improving patients’ health and the quality of human life.
Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with brain diseases.