The Food and Drug Administration has approved Invega Hafyera (paliperidone palmitate), an every 6-month injection, for the treatment of schizophrenia in adults.

Invega Hafyera is a long-acting atypical antipsychotic that is administered as a gluteal intramuscular injection by a health care professional. Prior to initiating treatment with Invega Hafyera, patients must have been adequately treated with a once-monthly injection of Invega Sustenna (paliperidone palmitate) for at least 4 months, or an every 3-month injection of Invega Trinza (paliperidone palmitate) for at least one 3-month cycle.

The approval was based on data from a 12-month, randomized, double-blind, noninferiority phase 3 study (ClinicalTrials.gov Identifier: NCT03345342) that compared the efficacy and safety of Invega Hafyera to Invega Trinza in 702 adults with schizophrenia who were previously stabilized on corresponding doses of Invega Sustenna or Invega Trinza. The study consisted of 3 phases: a screening phase (up to 28 days), a maintenance phase (1 or 3 months), and a double-blind phase (at least 12 months). 

The primary endpoint was the time to first relapse in the double-blind phase. Relapse was defined as emergence of 1 or more of the following: psychiatric hospitalization, an increase of at least 25% or a 10-point increase in Positive and Negative Syndrome Scale [PANSS] total score, deliberate self-injury, violent behavior, or suicidal/homicidal ideation.


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Results showed that at the end of the 12-month period, treatment with Invega Hafyera was found to be noninferior to Invega Trinza with regard to the primary endpoint. A relapse event was experienced by 7.5% and 4.9% of patients in the Invega Hafyera and Invega Trinza treatment groups, respectively, with the Kaplan-Meier estimated difference of 2.9% (95% CI, -1.1, 6.8). A subgroup analysis did not reveal any clinically significant differences in responsiveness on the basis of gender, age, or race.

“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,” said Gustavo Alva, MD, DFAPA, Medical Director at ATP Clinical Research and 6-month paliperidone palmitate clinical trial investigator.

The safety profile of Invega Hafyera was consistent with that seen in previous studies of Invega Sustenna and Invega Trinza with no new safety signals. The most common adverse reactions for Invega Hafyera were upper respiratory tract infection, injection site reaction, increased weight, headache, and parkinsonism.

Invega Hafyera is supplied as 1092mg/3.5mL and 1560mg/5mL paliperidone palmitate in a kit containing a single-dose prefilled syringe and safety needles. The product is expected to be available by early October.

References

  1. Janssen announces US FDA approval of Invega Hafyera (6-month paliperidone palmitate), first and only twice-yearly treatment for adults with schizophrenia. News release. Janssen Pharmaceuticals, Inc. Accessed September 1, 2021. https://www.prnewswire.com/news-releases/janssen-announces-us-fda-approval-of-invega-hafyera-6-month-paliperidone-palmitate-first-and-only-twice-yearly-treatment-for-adults-with-schizophrenia-301366768.html
  2. Invega Hafyera [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2021.