Summary

• A phase 3, 12-month, randomized, double-blind (DB), active-controlled, parallel-group, non-inferiority trial was conducted to evaluate the efficacy and safety of INVEGA HAFYERA^® (N=478) relative to INVEGA TRINZA^® (N=224) in delaying time to first relapse in adults with schizophrenia who were previously stabilized on corresponding doses of INVEGA SUSTENNA^® or INVEGA TRINZA^®.¹
• Upper respiratory tract infection (URTI), as described in the INVEGA HAFYERA Prescribing Information, represents a combination of terms that includes URTI, nasopharyngitis, pharyngitis, rhinitis, viral pharyngitis and viral upper respiratory tract infection.²
• URTI, as described above, was reported at an incidence of 12% in INVEGA HAFYERA treated patients vs 13% of INVEGA TRINZA treated patients during the DB phase of the trial.²
  • Nasopharyngitis contributed to the largest percentage of adverse events for this combination term (INVEGA TRINZA:5.8%; INVEGA HAFYERA: 4.6%) during the DB phase.³
• No patients discontinued based on a report of URTI.⁴

DOSAGE STRENGTH INFORMATION

Doses of paliperidone palmitate extended-release injectable suspension may be expressed in milligram equivalents of paliperidone (active moiety) or milligrams of paliperidone palmitate. Dosage information in this response has been converted to mg of paliperidone palmitate to reflect the commercially available INVEGA SUSTENNA, INVEGA TRINZA, and INVEGA HAFYERA dosage strengths. The conversion factor from mg eq. to mg is 1.56.

• INVEGA SUSTENNA doses expressed as 78, 156 and 234 mg of paliperidone palmitate are equal to 50, 100 and 150 mg eq., respectively.
• INVEGA TRINZA doses expressed 546 and 819 mg of paliperidone palmitate are equal to 350 and 525 mg eq., respectively.
• INVEGA HAFYERA doses expressed as 1,092 and 1,560 mg of paliperidone palmitate are equal to 700 and 1,000 mg eq., respectively.

CLINICAL DATA

Non-inferiority Trial

A phase 3, randomized, DB, active-controlled, parallel-group, multicenter, non-inferiority trial was conducted to evaluate the efficacy and safety of INVEGA HAFYERA relative to INVEGA TRINZA on time to first relapse in adults with schizophrenia who were previously stabilized on corresponding doses of INVEGA SUSTENNA or INVEGA TRINZA.¹ See FIGURE: Study Design

URTI is reported in the US Prescribing Information as a combination of terms that includes URTI, nasopharyngitis, pharyngitis, rhinitis, viral pharyngitis and viral upper respiratory tract infection.² During the DB phase of the study, 13% and 12% of patients in the INVEGA TRINZA and INVEGA HAFYERA groups, respectively, experienced AEs comprising the combination term for URTI. Nasopharyngitis represented the largest proportion of the URTI-combined terms.³ The reporting rate for the individual URTI adverse event terms during the DB phase of the trial is described in Table: Adverse Events Included in Combination Term for Upper Respiratory Tract Infection Adverse Events During the DB Phase of the Study.

None of the URTI adverse events in the DB phase of the trial led to study drug discontinuation.⁴

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, DERWENT^® (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 22 August 2024.