Janssen Pharmaceuticals gets FDA nod for Invega Sustenna

TITUSVILLE, N.J. — Janssen Pharmaceuticals announced that the Food and Drug Administration approved the company's supplemental new drug application for the once-monthly Invega Sustenna (paliperidone palmitate), an antipsychotic used to treat schizoaffective disorder as either monotherapy or adjunctive therapy. 

 

The FDA granted the SNDA priority review. Invega Sustenna is the first and only FDA-approved once-monthly medication to treat schizoaffective disorder as monotherapy, the company stated. 

 

"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. "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."

 

The approval is based on data from a long-term study measuring the ability to delay relapse in schizoaffective disorder, according to the company. The study revealed that treatment with Invega Sustenna resulted in a significant delay in relapse due to mood and psycotic symptoms of schizoaffective disorder when compared to a placebo. Results of the study were presented earlier this year at the 167th Meeting of the American Psychiatric Association.