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Based on the interim analysis, 93% of patients remained relapse-free with TREVICTA® during the double-blind phase

Based on the interim analysis, 93% of patients remained relapse-freeii with TREVICTA® during the
double-blind phase5


Interim-analysis

Adapted from Berwaerts J et al. 2015.
*Interim analysis considered as primary endpoint. The median treatment duration was 120 days for the transition phase,85 days for the maintenance phase, and 169 days for the group receiving 3-month paliperidone palmitate and 146 days for the placebo group in the DB phase.5
Shaded areas indicate 95% confidence interval for the estimated proportion of patients who remained in the study without relapse at distinct times after randomization in the double-blind phase. The median time to relapse was 274 days for placebo and was not estimable for the 3-month formulation of paliperidone palmitate.5
i. Patients who are adequately treated with 1-monthly paliperidone palmitate injectable (preferably for four months or more) and do not require dose adjustment may be switched to 3-monthly paliperidone palmitate injection.6

This double-blind (DB), placebo-controlled, relapse prevention study was designed to evaluate the efficacy and safety of the 3-month formulation of paliperidone palmitate vs placebo in delaying time to relapse of schizophrenia symptoms in patients previously treated with oncemonthly paliperidone palmitate for at least 4 months.5
The study consisted of 4 phases: screening and oral tolerability testing phase (≤3 weeks), openlabel (OL) transition phase, OL maintenance phase, and DB phase.5
In the 17-week transition phase, all patients except those switching from other LAI antipsychotics or those who were receiving once-monthly paliperidone palmitate before study entry received once-monthly paliperidone palmitate for 120 days, with the following doses: day 1:150 mg eq (deltoid); day 8: 100 mg eq (deltoid); days 36 and 64:50, 75, 100, or 150 mg eq flexible doses (deltoid or gluteal); and day 92: same dose of once-monthly paliperidone palmitate as on day 64.5
At the start of the 12-week maintenance phase, patients received a single dose of 3-month paliperidone palmitate in either the deltoid or gluteal muscle(dose of 3-month paliperidone palmitate was 3.5-fold that of the final once-monthly paliperidone palmitate dose administered on day 92).5

Stabilized patients were then randomized (1:1 ratio; via a sponsor-preparedcomputergeneratedrandomizationscheme; administered by an interactive voice/web response system) to receive either 3-month paliperidone palmitate or placebo in a DB phase with variable length (fixed dose of 3-month paliperidone palmitate). Patients assigned to 3-month paliperidone palmitate in the DB phase received the same dose that was administered on day120 of the maintenance phase; this dose remained fixed throughout the DB phase.5

References
1. INVEGA® Ministry of Health approved leaflet, 18/3/2019.
2. Risperdal® Ministry of Health approved leaflet, 16/12/2019.
3. INVEGA SUSTENNA® Ministry of Health approved leaflet, 18/3/2019.
4. TREVICTA® Ministry of Health approved leaflet.19/5/2019.
5. Berwaerts J, Liu Y, Gopal S, et al. Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2015;72(8):830-9.
6. TREVICTA® summary of product characteristics. Available at: https://www.ema.europa.eu/en
/documents/product-information/trevicta-epar-productinformation_en.pdf, last accessed 12th November 2020.

CP-253619

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