Positive data for Janssen’s three-month Invega Sustenna in schizophrenia

Three-month paliperidone palmitate, an investigational atypical antipsychotic, significantly delayed time to relapse compared to placebo in patients with schizophrenia, according to a new Phase III clinical study published last week in the Journal of the American Medical Association (JAMA) Psychiatry.

Results of the study served as the basis for the recent New Drug Application filing for three-month paliperidone palmitate injection to treat schizophrenia in adults with the US Food and Drug Administration by Janssen Research & Development, a unit of US health care giant Johnson & Johnson (NYSE: JNJ), which already markets the drug under the Invega Sustenna trade name, and was the study sponsor. The FDA granted the filing Priority Review status in January, with a regulatory action date of May 18, 2015.

Plans to file for approval in other markets