Abilify Maintena is a freeze-dried powder reconstituted with water to form an extended-release medication that can be injected once a month, according to the manufacturers, Otsuka and Lundbeck A/S. The current version of Abilify is taken by mouth daily.
The FDA approval follows positive results of a recent study showing that adults who got the injections had a greater delay in time to relapse and a lower rate of relapse compared with adults who received a placebo.
"Protection from relapse of schizophrenia is important for patients, their families, and the communities in which they live," researcher John M. Kane, MD, chair of psychiatry at the Zucker Hillside Hospital in Glen Oaks, N.Y., says in a company release.
"As a strong believer in long-acting therapies for schizophrenia, I think it is important for physicians to have a new and effective once-monthly treatment option that can help reduce the risk of relapse and manage symptoms in patients," he says.
Because of an increased risk of harm or death associated with antipsychotic use in the elderly, the company notes that this drug should not be used in elderly patients with dementia-related psychosis.
The medication also should not be given to people with a known hypersensitivity reaction to Abilify.