US FDA approves Janssen’s long-lasting schizophrenia treatment

The US Food and Drug Administration has approved the New Drug Application for atypical antipsychotic Invega Trinza (paliperidone palmitate) from Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Pharmaceuticals under priority review for schizophrenia.

Before starting the three-month injection Invega Trinza, patients must be adequately treated with Invega Sustenna (one-month paliperidone palmitate) for at least four months. In a long-term Phase III maintenance trial, 93% of patients treated with Invega Trinza did not experience a significant return of schizophrenia symptoms. Based on positive efficacy, Janssen concluded this study early following the recommendation of an Independent Data Monitoring Committee (IDMC).

Trial investigator Joseph Kwentus, Pecise Research Centers, said: “With a dosing interval that can be measured in seasons, not days, people living with schizophrenia and their treatment teams can focus on recovery goals beyond short-term symptom control. Recovery looks different for everyone, and the long-term symptom control offered by Invega Trinza, can help patients work toward their own personal goals."