Janssen Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic INVEGA® SUSTENNA® (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy.
The symptoms of schizoaffective disorder are complex and, without treatment, disabling. The FDA approved these sNDAs under priority review, which is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions.
INVEGA® SUSTENNA® is the first and only FDA-approved once-monthly medication to treat schizoaffective disorder as monotherapy.
"Clinicians often find themselves taking a complicated approach using multiple medications to address schizoaffective disorder symptoms because widely accepted guidelines for the treatment of the condition are not available," said David P. Walling, PhD, study lead investigator and Chief Executive and Clinical Officer, Collaborative NeuroScience Network, Inc., Los Angeles. "The approval of an effective once-monthly medication that can be used as monotherapy or adjunctive therapy to manage the symptoms associated with schizoaffective disorder has the potential to change that approach."
The approval is based on data from a 15-month period of a long-term maintenance study measuring ability to delay relapse in schizoaffective disorder. The study found that treatment with INVEGA® SUSTENNA® resulted in a statistically significant delay in relapse due to mood (depression and mania) and psychotic symptoms of schizoaffective disorder compared to placebo. Results of the study were presented in May at the 167th Annual Meeting of the American Psychiatric Association.
"Schizoaffective disorder is a difficult-to-treat disease. Approval of INVEGA® SUSTENNA® to manage the mood as well as the psychosis that define the condition has the potential to change the lives of the 750,000 adult Americans who suffer from it," said Dong-Jing Fu, MD, PhD, Director of Clinical Development at Janssen Scientific Affairs, LLC. "Janssen is proud to expand treatment options for those living with schizoaffective disorder and to provide new possibilities for the family members and friends who care for them."
Few large, controlled studies have systematically studied the clinical characteristics of schizoaffective disorder and long-term treatment options. This study, which included a 6-month open-label treatment period and a 15-month double-blind period, was the first registration trial to study maintenance treatment of a long-acting injectable in this complex disease. In addition to the approval of INVEGA® SUSTENNA® as monotherapy for schizoaffective disorder, it is approved as adjunctive therapy to mood stabilizers or antidepressants.
The most common INVEGA® SUSTENNA® adverse reactions, defined by at least a 5% incidence and twice that of placebo, are injection site reactions, somnolence/sedation, dizziness, akathisia and extrapyramidal disorder. No occurrences of these adverse events reached this threshold in this study of patients with schizoaffective disorder.