Janssen Receives FDA Approval For Schizoaffective Disorder Drug

FDA has approved antipsychotic for the acute treatment of schizoaffective disorder. Invega (paliperidone) extended-release tablets were approved for the acute treatment of schizoaffective disorder, either as monotherapy or adjunctive therapy to mood stabilizers and/or antidepressants.

The approval is based on two international, randomized, double-blind, placebo-controlled studies of patients with an established diagnosis of schizoaffective disorder, who were experiencing acute symptoms.

In the first six-week study, patients received flexible doses of Invega (3-12mg once daily). In the other study, patients were assigned to one of two dose levels of Invega : 6mg with the option to reduce to 3mg, or 12mg with the option to reduce to 9mg.

The Invega group in the flexible-dose study (dosed between 3 and 12mg/day, mean modal dose of 8.6 mg/day) and the higher dose group of Invega in the 2 dose-level study (12mg/day with option to reduce to 9mg/day), were each found to be superior to placebo in the positive and negative symptom scale (PANSS).

Husseini Manji, head of Global Therapeutic Area for Neuroscience at Johnson & Johnson, said: Schizoaffective disorder is a chronic, disabling condition. This new indication for Invega further demonstrates Janssen’s commitment to helping people with serious mental illnesses.