Supplemental New Drug Applications for once-monthly long-acting therapy INVEGA® SUSTENNA® submitted to the U.S. FDA for the treatment of schizoaffective disorder

Janssen Pharmaceuticals, Inc., today announced the submission of supplemental New Drug Applications (sNDAs) for once-monthly atypical long-acting antipsychotic INVEGA^® SUSTENNA^® (paliperidone palmitate) to the U.S. Food and Drug Administration (FDA) for approval to treat schizoaffective disorder as either monotherapy or adjunctive therapy. Without treatment, the symptoms of schizoaffective disorder are complex and disabling. Currently, treatment options approved to manage the symptoms of depression, mania and psychosis associated with the condition are limited.

INVEGA^® SUSTENNA^® is the first long-acting injection to be studied for the treatment of schizoaffective disorder and – if approved by the FDA – will be the only long-acting injection indicated to treat this condition. INVEGA^® SUSTENNA^® was approved by the FDA in July 2009 as the first once-monthly atypical long-acting medication to treat schizophrenia.

“There is a significant need for additional treatment options for the one million Americans with schizoaffective disorder,” said Michelle Kramer, Vice President, U.S. Neuroscience Medical Affairs, 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.”

The applications are based on a 15-month study that found INVEGA^® SUSTENNA^® met its primary endpoint of delayed time to and reduced risk of relapse compared to placebo and showed significant efficacy in manic and depressive mood symptoms and psychosis. In the study, INVEGA^® SUSTENNA^® also met its key secondary endpoint of improving and maintaining patient functioning. Results of the study were presented last week at the 167^th Annual Meeting of the American Psychiatric Association (APA) in New York City.

In this study, adverse events occurring in greater than 5% of patients in either group included weight gain (8.5% in INVEGA^® SUSTENNA^® vs. 4.7% in placebo), insomnia (4.9% vs. 7.1%), worsening of schizoaffective disorder (3.1% vs. 5.9%), headache (5.5% vs. 3.5%) and nasopharyngitis, which is the common cold (5.5% vs. 3.5%). The most common (≥2%) movement disorders were akathisia (3.0% in INVEGA^® SUSTENNA^® vs. 1.8% in placebo) and tremor (1.2% vs. 2.4%). Thirteen percent (13.0%) in the INVEGA^® SUSTENNA^® group and 6.0% in the placebo group had ≥7% increase in body weight. Potentially prolactin-related adverse events were reported in 10.4% of patients in the INVEGA^® SUSTENNA^® group and 3.5% in the placebo group.