Janssen Wins FDA Approval for Long-Acting Schizophrenia Drug

The U.S. Food and Drug Administration (FDA) greenlit Janssen’s long-acting, twice-per-year schizophrenia drug Invega Hafyera (paliperidone palmitate six-month). This is the first long-acting antipsychotic drug of its kind that provides six months’ control of symptoms with a single dose and is expected to benefit patients who have had difficulties adhering to a more strict treatment regimen.

Approval was based on data from a Phase III non-inferiority study that showed Invega Hafyera compared to Invega Trinza, a three-month formulation of paliperidone palmitate. The results from the Route 6 Study showed that 92.5% of patients treated with Invega Hafyera and 95% treated with Invega Trinza were relapse-free after one year of treatment. A definition of relapse included psychiatric hospitalization, self-injury, violent behavior, or suicidal/homicidal ideation. Research has consistently found a link between low adherence to schizophrenia treatment and relapse.

“For too long, we’ve accepted relapse as a normal part of living with schizophrenia, while research continues to demonstrate that stronger medication adherence means better patient outcomes,” Dr. Gustavo Alva, medical director at ATP Clinical Research and six-month paliperidone palmitate clinical trial investigator, said in a statement. “The Phase III trial results provide compelling evidence that six-month paliperidone palmitate offers longer-term symptom control with the fewest doses per year, which may support greater patient adherence.”

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