FDA Approves First Twice-Yearly Treatment for Schizophrenia in Adults


In a study, 92.5% of patients treated with the 6-month regimen of Invega and 95% of patients treated with the 3-month regimen were relapse-free at 12 months.

Paliperidone palmitate (Invega Hafyera; Janssen) has been approved by the FDA as the first and only twice-yearly treatment for adults with schizophrenia, offering the fewest doses per year, according to a press release.

The drug is a long-acting atypical antipsychotic injection. Before transitioning to the 6-month dosages, patients must be treated with 1-month paliperidone palmitate for at least 4 months or the 3-month paliperidone palmitate for at least one 3-month injection cycle.

Schizophrenia is a complex disorder in which the symptoms and potential for relapse can impact many aspects of individuals’ daily lives. According to the press release, the average adult with schizophrenia experiences 9 relapses in less than 6 years, often due to missed doses of medication. In addition to significant functional, emotional, and financial burdens, patients who experience more relapses may have more hospitalizations, which can lead to higher medical costs for patients, health systems, and payers.

“Long-acting injectable treatments offer a number of advantages compared to oral medication for schizophrenia, including relief from needing to remember to take medication daily, lower discontinuation rates, and sustained treatment over longer periods,” said Bill Martin, PhD, global therapeutic area head of neuroscience at Janssen Research and Development LLC, in the press release. “Today’s approval enables us to rethink how we manage this chronic disease by offering patients and caregivers the potential for a life less defined by schizophrenia medication.”

The approval of the 6-month paliperidone palmitate is based on data from a 12-month, randomized, double-blind, non-inferiority phase 3 trial that enrolled 702 adults with schizophrenia from 20 countries. The results showed non-inferiority of the 6-month paliperidone palmitate compared with the 3-month regimen in the primary endpoint of time to first relapse following the 12-month treatment period.

Furthermore, the results found that 92.5% of patients treated with the 6-month regimen and 95% of patients treated with the 3-month regimen were relapse-free at 12 months. According to the press release, relapse was defined as psychiatric hospitalization, increase in the Positive and Negative Syndrome Scale (PANSS) total score, increase in individual PANSS item scores, self-injury, violent behavior, or suicidal or homicidal ideation.

The safety profile observed in the trial was consistent with previous studies of the 1-month and 3-month paliperidone palmitate treatments. The most common adverse events were upper respiratory tract infection (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 a trial investigator in the 6-month paliperidone palmitate study, in the press release. “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.”


Janssen Announces US FDA Approval of Invega Hafyera (6-month paliperidone palmitate), First and Only Twice-Yearly Treatment for Adults with Schizophrenia. News release. Johnson & Johnson; September 1, 2021. Accessed September 7, 2021. https://www.jnj.com/janssen-announces-u-s-fda-approval-of-invega-hafyera-6-month-paliperidone-palmitate-first-and-only-twice-yearly-treatment-for-adults-with-schizophrenia

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