In a Noninferiority Study, INVEGA HAFYERA™ Delayed Relapse as Effectively as INVEGA TRINZA®

Noninferiority Study

Safety & Adverse Events

  • In the double-blind phase, 1.3% of patients in the INVEGA HAFYERA™ group and 0.4% of patients in the INVEGA TRINZA® group discontinued due to adverse events
  • The most common adverse reactions (≥5%) in the INVEGA HAFYERA™ group were upper respiratory tract infection (12%), injection-site reaction (11%), weight increased (9%), headache (7%), and extrapyramidal symptoms* (7%)
  • The most common adverse reactions (≥5%) in the INVEGA TRINZA® group were upper respiratory tract infection (13%), weight increased (8%), injection-site reaction (5%), extrapyramidal symptoms* (5%), and headache (5%)

Study Design

Click the button below for a walk-through of each phase of the noninferiority study.

View Study Design Details

Of the 1036 Participants Who Entered the Initial Screening Phase, 702 Continued on to the 12-month, Randomized, Double-blind Phase of the Noninferiority Trial2

Flowchart depicting study design for the noninferiority trial

PP1M: paliperidone palmitate 1-month (INVEGA SUSTENNA®).

PP3M: paliperidone palmitate 3-month (INVEGA TRINZA®).

PP6M: paliperidone palmitate 6-month (INVEGA HAFYERA™).

A total of 702 stabilized patients were randomized in a 2:1 ratio to receive INVEGA HAFYERA™ (n=478) or INVEGA TRINZA® (n=224) over the 12-month double-blind phase.

INVEGA HAFYERA™ Was Noninferior to INVEGA TRINZA® After the 12-Month Double-blind Phase1,3

Line graph depicting results of the noninferiority trial

Study Criteria

Key Inclusion Criteria4

  • Age: 18 to 70 years
  • Diagnosed with schizophrenia (per DSM-5) for at least 6 months before screening
  • Receiving treatment with INVEGA SUSTENNA®, INVEGA TRINZA®, injectable risperidone, or any oral antipsychotic
  • Total PANSS scores of <70 points at screening and at randomization

Key Exclusion Criteria4

  • Receiving any form of involuntary treatment
  • Suicide attempt within 12 months before screening or imminent risk of suicide or violent behavior
  • DSM-5 diagnosis of moderate or severe substance use disorder (except for nicotine and caffeine) within 6 months of screening
  • History of NMS or TD
  • Unstable medical conditions
  • History of unresponsiveness or intolerance to paliperidone/risperidone

Relapse Criteria1

Relapse was defined as any of the following:

  • Psychiatric hospitalization
  • Increase of ≥25% in total PANSS score from randomization for 2 consecutive assessments (if baseline score was >40)
  • 10-point increase in total PANSS score for 2 consecutive assessments (if baseline score was ≤40)
  • Deliberate self-injury, violent behavior, or suicidal/homicidal ideation
  • Score of ≥5 (if the maximum baseline score was ≤3) or ≥6 (if the maximum baseline score was 4) on 2 consecutive assessments of the specific PANSS items

PANSS=Positive and Negative Syndrome Scale.

NMS=neuroleptic malignant syndrome.

TD=tardive dyskinesia.

*Extrapyramidal symptoms include: blepharospasms, bradykinesia, drooling, dyskinesia, dystonia, hypokinesia, musculoskeletal stiffness, muscle rigidity, muscle spasms, oculogyric crisis, Parkinsonism, Parkinsonism rest tremor, reduced facial expression, tardive dyskinesia.

REFERENCES: 1. INVEGA HAFYERA™ [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; August 2021. 2. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ. 3. US National Library of Medicine. A study of paliperidone palmitate 6-month formulation. ClinicalTrials.gov. Accessed July 30, 2021. https://clinicaltrials.gov/ct2/show/NCT03345342