Otsuka Pharmaceutical and H. Lundbeck have announced marketing authorization approval from the European Commission for Abilify Maintena (aripiprazole), an intramuscular (IM) once-monthly injectable formulation for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.
Abilify Maintena reduces the risk of relapse relative to placebo over the long-term and provides effective treatment of schizophrenia.
It has a tolerability profile similar to oral aripiprazole, and demonstrated statistically significant benefits on patients' personal and social functioning as compared to placebo. A total of 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.
Otsuka Europe CEO and president Ole Vahlgren noted the company strongly believes 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. We must partner with health care professionals and caregivers to help patients get the best treatments that focus on reducing the risk of relapse," Vahlgren added.
Lundbeck international markets and Europe senior vice president Ole Chrintz noted studies have shown that the early use of long-acting injectables can prevent a person with schizophrenia from experiencing a relapse.
"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," Chrintz added.
