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

  • J. Berwaerts (a1), Y. Liu (a2), S. Gopal (a1), I. Nuamah (a3), H. Xu (a3), A. Savitz (a1), D. Coppola (a1), A. Schotte (a4), B. Remmerie (a4), N. Maruta (a5) and D. Hough (a1)...

Abstract

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.

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

  • J. Berwaerts (a1), Y. Liu (a2), S. Gopal (a1), I. Nuamah (a3), H. Xu (a3), A. Savitz (a1), D. Coppola (a1), A. Schotte (a4), B. Remmerie (a4), N. Maruta (a5) and D. Hough (a1)...

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

  • J. Berwaerts (a1), Y. Liu (a2), S. Gopal (a1), I. Nuamah (a3), H. Xu (a3), A. Savitz (a1), D. Coppola (a1), A. Schotte (a4), B. Remmerie (a4), N. Maruta (a5) and D. Hough (a1)...
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