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Efficacy and Safety of Paliperidone Palmitate 3-month Formulation in Schizophrenia: a Randomized, Double-blind, Placebo-controlled Study

Published online by Cambridge University Press:  15 April 2020

J. Berwaerts ,
Y. Liu ,
S. Gopal ,
I. Nuamah ,
H. Xu ,
A. Savitz ,
D. Coppola ,
A. Schotte ,
B. Remmerie  and
N. Maruta
...Show all authors
J. Berwaerts
Affiliation:
Central Nervous System, Janssen Research & Development LLC, Titusville, USA
Y. Liu
Affiliation:
R&D – CDO – Senior Biostatistician, Janssen R&D, Beijing, China
S. Gopal
Affiliation:
Central Nervous System, Janssen Research & Development LLC, Titusville, USA
I. Nuamah
Affiliation:
Clinical Biostatistician, Janssen Research & Development LLC, Titusville, USA
H. Xu
Affiliation:
Clinical Biostatistician, Janssen Research & Development LLC, Titusville, USA
A. Savitz
Affiliation:
Central Nervous System, Janssen Research & Development LLC, Titusville, USA
D. Coppola
Affiliation:
Central Nervous System, Janssen Research & Development LLC, Titusville, USA
A. Schotte
Affiliation:
Clinical, Janssen Research & Development Division of Janssen Pharmaceutica NV, Beerse, Belgium
B. Remmerie
Affiliation:
Clinical, Janssen Research & Development Division of Janssen Pharmaceutica NV, Beerse, Belgium
N. Maruta
Affiliation:
Central Nervous System, Institute of Neurology Psychiatry and Narcology of the Academy of Medical Science of Ukraine, Kharkiv, Ukraine
D. Hough
Affiliation:
Central Nervous System, Janssen Research & Development LLC, Titusville, USA

Abstract

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Aim

This double-blind (DB), relapse prevention, phase-3 study was designed to evaluate the efficacy and safety of paliperidone palmitate long-acting 3-monthly formulation (PP3M) versus placebo in delaying time-to-relapse of schizophrenia symptoms.

Methods

Adults (18-70 years old) with schizophrenia (DSM-IV-TR) were treated with PP (17-week, open-label [OL] transition phase: 50, 75, 100, or 150 mg eq, once-monthly, [PP1M]; 12-week OL maintenance phase: 3.5-fold PP1M stabilized dose, single injection), and then randomized (1:1) to PP3M fixed doses (175, 263, 350 or 525 mg eq.) or placebo.

Results

305/506 patients enrolled were randomized (PP3M: n=160; placebo: n=145); majority were men (75%), white (59%), mean age 38.4 years. Interim analysis results favored PP3M vs. placebo (p = 0.0002, two-sided log-rank test; HR: 3.45, 95% CI: 1.73; 6.88); median time-to-relapse was 274 days in placebo and not estimable in PP3M group. Final results were consistent with interim analysis. Both PANSS total score and CGI-S score showed a significant effect over time in PP3M- vs. placebo-treated patients (p>0.001). 330/506 (65.2%) patients in OL phase and 183/305 (60.0%) in DB phase (PP3M: 61.9% vs. placebo: 57.9%) had ≥1 treatment-emergent adverse event (TEAE). The TEAEs noted more frequently in PP3M-vs. placebo (DB phase) were nasopharyngitis (5.6% vs. 1.4%), weight gain (8.8% vs. 3.4%), headache (8.8% vs.4.1%) and akathisia (4.4% vs. 0.7%).

Conclusion

Compared with placebo, PP3M significantly delayed time to first relapse in patients with schizophrenia, previously treated for 4 months with PP1M. PP3M was tolerable with a safety profile generally consistent with other marketed formulations of paliperidone.

Type
Article: 0272
Information
European Psychiatry , Volume 30 , Issue S1: Abstracts of the 23rd European Congress of Psychiatry , March 2015 , pp. 1
Copyright
Copyright © European Psychiatric Association 2015
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