Janssen’s Invega Sustenna Receives FDA Approval

FDA has approved Invega Sustenna (paliperidone palmitate) extended-release injectable suspension for maintenance and treatment of schizophrenia in adults.

The approval is based on four acute symptom control studies and a longer-term maintenance study that compared Invega Sustenna to placebo. Invega Sustenna was found to be superior to placebo in improving positive and negative syndrome scale (PANSS) total scores in the acute treatment trials. It delayed time to relapse as compared to placebo in the longer-term maintenance study.

The efficacy of Invega Sustenna in maintaining symptomatic control in schizophrenia was evaluated in a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Time-to-first relapse – the primary endpoint of the study – was significantly longer for patients, said the company.

Husseini Manji, head of Global Therapeutic Area for Neuroscience at Johnson & Johnson, said: Invega Sustenna provides healthcare professionals the opportunity to rethink their overall approach to how they treat schizophrenia by using long-acting therapies. The approval of Invega Sustenna demonstrates our commitment to providing valuable novel therapies for schizophrenia. Invega Sustenna has a demonstrated safety profile that can help healthcare professionals address the issue of medication adherence and can also help many patients delay the time to relapse.