FDA Approves Drug for Schizophrenia to be Administered at a Six Month Interval
September 1, 2021   

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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     Additional Resources:

NEI Podcast:
Episode 108 - Novel Strategies to Treat Schizophrenia with Dr. Leslie Citrome
Encore Presentation:
You Don't Scare Me: Use of Long-Acting Injectables in Schizophrenia

CME credits: 0.75 | Date: November 8, 2023
CNS Spectrums
Long-Acting Injectable Antipsychotics: What, When, and How
CME credits: 1.0 | Date: February 18, 2024
Encore Presentation:
Let's Get to the Point: Why We Should Include Long-Acting Injectables in the Treatment of Schizophrenia

CME credits: 0.75 | Date: November 8, 2023
NEI Resources
Topic: Long-Acting Injectables
Encore Presentation:
Preventing Relapse Today: Making a Difference for a Lifetime

CME credits: 1.25 | Date: November 10, 2022