Invega Hafyera approved for the biannual treatment of schizophrenia

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

Invega Hafyera is a long-acting, atypical antipsychotic that is given by healthcare professionals as an intramuscular injection into the buttock area. Before starting Invega Hafyera, patients must be injected with Invega Sustenna (paliperidone palmitate) once a month for at least 4 months or with Invega Trinza (paliperidone palmitate) injected every 3 months for at least a 3 month cycle.

The approval was based on data from a 12-month, randomized, double-blind, phase 3 non-inferiority study ( Identifier: NCT03345342) that compared the efficacy and safety of Invega Hafyera with Invega Trinza in 702 adults with schizophrenia who were previously stabilized on appropriate Invega Sustenna or Invega Trinza cans. 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).

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The primary endpoint was time to first relapse in the double-blind phase. Relapse was defined as the occurrence of 1 or more of the following symptoms: psychiatric hospitalization, an increase of at least 25%, or an increase of 10 points on the positive and negative syndrome scale [PANSS] Total score, willful self-harm, violent behavior, or thoughts of suicide / murder.

Results showed that Invega Hafyera treatment was not inferior to Invega Trinza for the primary endpoint at the end of the 12 month period. Relapse occurred in 7.5% and 4.9% of patients in the Invega Hafyera and Invega Trinza treatment groups, respectively, with the Kaplan-Meier difference of 2.9% (95% CI, -1.1, 6 , 8) was estimated. Subgroup analysis revealed no clinically significant differences in responsiveness based on gender, age, or race.

“The Phase 3 trial results provide compelling evidence that paliperidone palmitate provides longer-term symptom control over a 6-month period with the lowest doses per year, which can support better patient adherence,” said Gustavo Alva, MD, DFAPA, more medically Director at ATP Clinical Research and investigator for clinical studies with paliperidone palmitate for 6 months.

Invega Hafyera’s safety profile was consistent with previous studies with Invega Sustenna and Invega Trinza with no new safety signals. The most common side effects with Invega Hafyera were upper respiratory tract infections, injection site reactions, weight gain, headache and parkinsonism.

Invega Hafyera is supplied as 1092 mg / 3.5 ml and 1560 mg / 5 ml paliperidone palmitate in a kit with a single-dose pre-filled syringe and safety pins. The product is expected to be available in early October.


  1. Janssen Announces FDA Approval for Invega Hafyera ™ (6 Month Paliperidone Palmitate), the first and only biannual treatment for adults with schizophrenia. Press release. Janssen Pharmaceuticals, Inc. Accessed September 1, 2021. first-and-only-twice-a-year-treatment-for-adults-with-schizophrenia-301366768.html.
  2. Invega Hafyera [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc .; 2021.

This article originally appeared on MPR

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