The Janssen Pharmaceutical Companies of Johnson & Johnson announced the FDA has approved long-acting atypical antipsychotic INVEGA HAFYERA™ (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. Before transitioning to INVEGA HAFYERA™, patients must be adequately treated with INVEGA SUSTENNA® (1-month paliperidone palmitate) for at least four months, or INVEGA TRINZA® (3-month paliperidone palmitate) for at least one 3-month injection cycle.
The FDA approval of INVEGA HAFYERA™ is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries. The results showed non-inferiority of INVEGA HAFYERA™ compared to INVEGA TRINZA® on the primary endpoint of time to first relapse at the end of the 12-month period. Results found that 92.5 percent of patients treated with INVEGA HAFYERA™ and 95 percent treated with INVEGA TRINZA® were relapse-free at 12 months. Relapse was defined as psychiatric hospitalization, increase in Positive and Negative Syndrome Scale [PANSS] total score, increase in individual PANSS item scores, self-injury, violent behavior, or suicidal/homicidal ideation.
The safety profile observed in the trial was consistent with previous studies of INVEGA SUSTENNA® and INVEGA TRINZA® with no new safety signals emerging. The most common adverse reactions (≥5%) in the INVEGA HAFYERA™ clinical trial were upper respiratory tract infection (12%), injection site reaction (11%), weight increase (9%), headache (7%), and parkinsonism (5%).
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