The company said that without treatment, the symptoms of schizoaffective disorder are complex and disabling.
At present, there are limited treatment options approved for managing the symptoms of depression, mania and psychosis associated with the condition.
INVEGA SUSTENNA is the first long-acting injection to be evaluated for the treatment of schizoaffective disorder and, if approved it will be the only injection indicated for this condition.
The injection was approved by the FDA in July 2009 as the first once-monthly atypical long-acting medication for the treatment of schizophrenia.
Janssen vice president of US Neuroscience Medical Affairs Michelle Kramer said there is a significant need for additional treatment options for the one million Americans with schizoaffective disorder.
"Having pioneered the development of atypical long-acting treatments for mental illness, Janssen is proud to expand our commitment to mental health with the submission of the sNDAs for what could potentially be the first once-monthly therapy for schizoaffective disorder," Kramer said.
The sNDAs are based on a 15-month trial that found INVEGA SUSTENNA met its primary endpoint of delayed time to and reduced risk of relapse compared to placebo and demonstrated significant efficacy in manic and depressive mood symptoms and psychosis.
In the trial, the drug also met its key secondary endpoint of improving and maintaining patient functioning.
Image: If approved by the FDA, INVEGA SUSTENNA will be the only long-acting injection indicated to treat schizoaffective disorder. Photo: courtesy of Vberger