FDA Approves Long-Acting Schizophrenia Treatment


Six-month paliperidone palmitate is the only twice-yearly injectable treatment for patients with schizophrenia.

The US Food and Drug Administration (FDA) has approved a 6-month paliperidone palmitate (INVEGA HAFYERA), a long-acting atypical antipsychotic for the treatment of adult patients with schizophrenia.

The Drug

The treatment, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, represents the first-and-only twice-yearly injectable treatment for schizophrenia.

Eligible patients for the treatment must first be adequately treated with 1-month paliperidone palmitate (INVEGA SUSTENNA) for at least 4 months or 3-month paliperidone palmitate (INVEGA TRINZA) for at least 1 3-month injection cycle.

The treatment is administered through a healthcare provider in the upper buttocks area every 6 months, dissolving slowly into the bloodstream following injection to provide continuous treatment and symptom control over 6 months.

The Study

The approval is based on a 12-month, randomized, double-blind, non-inferiority phase 3 study involving 702 adult patients between 18-70 years living with schizophrenia from 20 countries.

The treatment was non-inferior to 3-month paliperidone palmitate in achieving the primary endpoint of the time to first relapse after 12 months, where 92.5% of patients treated with the study drug and 95% of participants treated with the 3 month version were relapse-free at 12 months.


The treatment also had a safety profile consistent with previous studies of the comparison drugs, with no new safety signals found. Common adverse reactions included upper respiratory tract infections (12%), injection site reaction (11%), weight increase (9%), headache (7%), and parkinsonism (5%).

"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," said Gustavo Alva, MD, DFAPA, Medical Director at ATP Clinical Research and 6-month paliperidone palmitate clinical trial investigator, in a statement.

"The Phase 3 trial results provide compelling evidence that 6-month paliperidone palmitate offers longer-term symptom control with the fewest doses per year, which may support greater patient adherence."

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