Janssen's Invega Sustenna sNDA Approved By FDA

Johnson & Johnson company Janssen Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted approval to the company’s Supplemental New Drug Application (sNDA) for Invega Sustenna as a monotherapy or adjunct treatment for schizoaffective disorder.

Invega Sustenna (paliperidone palmitate) is an FDA-approved once-monthly treatment for schizophrenia and is indicated as a monotherapy for schizoaffective disorder.

The sNDA for Invega Sustenna was supported by data from a long-term maintenance study investigating the drug’s ability to delay relapse in schizoaffective disorder. Findings show that Invega Sustenna significantly delayed depression- and mania-related relapse as well as psychotic symptoms of schizoaffective disorder when compared to placebo. The trial results were presented at the 167th Annual Meeting of the American Psychiatric Association.

The mental illness schizoaffective disorder is characterized by delusions, hallucinations, mania, and depression. “Schizoaffective disorder is a difficult-to-treat disease. Approval of Invega Sustenna to manage the mood as well as the psychosis that both define the condition has the potential to change the lives of the 750,000 adult Americans who suffer from it,” said Dr. Dong-Jing Fu, Director of Clinical Development at Janssen Scientific Affairs.

Earlier this year, the company reported that patients who were prescribed Invega Sustenna and enrolled in the Janssen Connect program achieved medication adherence, which is considered a significant factor in successful treatment of schizophrenia.

Dr. David P. Walling, study lead investigator and Chief Executive and Clinical Officer of Collaborative NeuroScience Network, said, “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. 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.”