Abstract
It is known to be difficult for schizophrenia to maintain medication adherence, therefore the relapse and exacerbation of hospitalization risk due to lower adherence are regarded as unmet medical needs. To overcome this issue, ABILIFY MAINTENA® (aripiprazole) for extended-release injectable suspension was developed using the property of lower solubility of aripiprazole hydrate crystals in neutral solution. In clinical trials, ABILIFY MAINTENA® demonstrated that every 4 weeks injections maintained the effective plasma concentration and delayed the time to relapse of psychiatric symptoms significantly compared to the placebo group. Currently, ABILIFY MAINTENA® is marketed in more than 30 countries including Japan, the United States and Europe, and it came to be used as one treatment option for schizophrenia. This article describes the characteristics of this drug formulation, the history of formulation development, pharmacokinetics, and clinical results.