The US Food and Drug Administration (FDA) issued Complete Response Letter to Janssen Pharmaceuticals' supplemental new drug application (sNDA) for once-monthly long-acting antipsychotic Invega Sustenna (paliperidone palmitate).

The sNDA seeks to expand the product's label to include data showing that treatment with Invega Sustenna is effective six months longer than commonly prescribed oral antipsychotics in people with schizophrenia.

Invega Sustenna was approved by the FDA in July 2009 as the first once-monthly atypical long-acting injectable antipsychotic to treat schizophrenia and is now approved in more than 80 countries.

"Janssen remains committed to ensuring long-term treatment success for the 2.4 million adult Americans living with schizophrenia and to providing novel solutions for the family members and friends who care for them," said Larry Alphs, MD, PhD, Psychiatry Therapeutic Team Lead, Medical Affairs, Janssen Pharmaceuticals, Inc.

"We are evaluating the content of the Complete Response letter and look forward to continuing productive discussions with the FDA to advance this supplemental New Drug Application."

The proposed label update is based on investigational data from the landmark Paliperidone Palmitate Research In Demonstrating Effectiveness (PRIDE) study. PRIDE is the first real-world head-to-head antipsychotic study comparing Invega Sustenna, a once-monthly long-acting therapy, with commonly prescribed oral medications to treat schizophrenia within the context of many real-world issues faced by patients in their daily lives, including challenging situations such as recent incarceration or substance abuse.

Data from the PRIDE study was presented at the 167th annual meeting of the American Psychiatric Association in May 2014, and published in The Journal of Clinical Psychiatry in April 2015.

Invega Sustenna (paliperidone palmitate) was approved by the U.S. FDA in July 2009 as the first once-monthly atypical long-acting injection to treat schizophrenia. In November 2014, the FDA approved Invega Sustenna for the treatment of schizoaffective disorder, making it the first and only once-monthly medication to treat this condition; however, this population was not studied as part of the PRIDE trial.

Janssen Pharmaceuticals, Inc, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to addressing and resolving the major unmet medical needs of our time.