FDA Approves Twice-a-Year Therapy for Schizophrenia

The FDA has approved Janssen’s long-acting atypical antipsychotic Invega Hafyera (paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults.

The approval is based on the results of a 12-month, non-inferiority phase 3 study that enrolled 702 adults from 20 countries. The results showed non-inferiority of Invega Hafyera compared with Invega Trinza, which is given every three months. Results found that 92.5% of patients treated with Hafyera and 95% treated with Trinza were relapse-free at 12 months.

Safety was consistent between both products with most common adverse events being upper respiratory tract infection (12%), injection site reaction (11%), weight increase (9%), headache (7%), and parkinsonism (5%).

Before transitioning to Hafyera, patients must be adequately treated with Invega Sustenna, the once-a-month version, for at least four months or with Trinza for one three-month injection cycle.

“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,” Gustavo Alva, M.D., medical director at ATP Clinical Research and a clinical trial investigator, said in a statement. “The phase 3 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.”

Adherence to medication has historically been challenging in this patient population. About 75% of patients with schizophrenia discontinue their antipsychotic drug treatment within 18 months. Studies have found nonadherences is related to multiple factors, including negative, previous nonadherence, substance abuse, shorter illness duration, inadequate discharge planning or aftercare environment, and poorer therapeutic alliance.

Estimates of the prevalence of schizophrenia and related psychotic disorders in the United States range from 0.25% to 0.64%, according to the National Institute of Mental Health.