Janssen submits sNDAs for Invega Sustenna to treat schizoaffective disorder

Janssen Pharmaceuticals Inc. announced in a press release Tuesday the submission of supplemental new drug applications, or sNDAs, for its once-monthly atypical long-lasting antipsychotic Invega Sustenna to the FDA to treat schizoaffective disorder.

If approved by the FDA, Invega Sustenna (paliperidone palmitate) will be the first long-acting injection to treat schizoaffective disorder. The drug was approved by the FDA in July 2009 to treat schizophrenia.

The applications are based on results from a 15-month study that found the drug effective in delaying relapse time compared with placebo and in managing manic and depressive mood symptoms and psychosis. Results of the study were presented at the 167th Annual Meeting of the American Psychiatric Association in New York City.

"There is a significant need for additional treatment options for the 1 million Americans with schizoaffective disorder," said Michelle Kramer, vice president of US neuroscience medical affairs at Janssen. "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."