Significance Statement
schizophrenia
Long-acting injectable (LAI) antipsychotic medications are an important treatment option for patients with schizophrenia, particularly those at risk of non-adherence to daily oral antipsychotic medications or challenges for frequent health care. The administration frequency of LAIs ranges from every 2 weeks to every 3 months, except for paliperidone palmitate 6-month formulation (PP6M), which has the longest available dosing-option of twice-yearly administration. PP6M is approved for treatment of schizophrenia in adults after adequate treatment with its 1-month (PP1M) or 3-month (PP3M) counterparts. The phase 3 double-blind study of PP6M (NCT03345342) demonstrated noninferiority of PP6M to PP3M in prevention of relapses, with no new safety concerns. The current study is a 2-year open-label extension of PP6M double-blind study and demonstrated long-term efficacy and safety with low patient relapse rates. Thus PP6M, with only 2 dose administrations annually, is a potential option for long-term treatment of patients with schizophrenia, especially if adherence or healthcare access are concerns.