The US Food and Drug Administration (FDA) has approved a 6-month injection form of the long-acting atypical antipsychotic paliperidone palmitate (Invega Hafyera, Janssen Pharmaceuticals) for the treatment of schizophrenia in adults. Invega Hafyera is the first long-acting schizophrenia medication to be injected once every six months, while other approved long-acting injectable antipsychotics are administered every few weeks to every three months. Invega Hafyera should only be used after a patient has been adequately treated with a one-month injectable suspension (e.g. Sustenna) for at least four months, or a one-time three-month injectable suspension (e.g. Trinza). The approval 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. Study results showed over 92% of participants were relapse free at 12 months. The most common adverse reactions affecting at least 5% of participants in the clinical trial receiving twice-year paliperidone were upper respiratory tract infection (12%), injection site reaction (11%), weight gain (9%), headache (7%), and parkinsonism (5%).
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