Efficacy and tolerability of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 6-week placebo-controlled studies (PAL-SCH-303/304/305)

Efficacy and safety of paliperidone ER tablets in acute schizophrenia patients were evaluated in this pooled analysis. Data from 3 international, 6-week, multi-center, double-blind, randomized, placebo-controlled, dose-response studies in patients treated with fixed-doses of paliperidone ER (3, 6, 9, 12 or 15mg) or placebo daily were analyzed. Analysis included PANSS, PSP, patient response (endpoint improvement in PANSS total score by ≥30%), treatment-emergent AEs (TEAEs) and bodyweight. ITT population=1306, mean±SD age=38.3±10.9y and baseline PANSS total score=93.5±11.8. At endpoint, mean PANSS total score significantly improved for all paliperidone ER doses vs. placebo (3mg=–15.0±19.6, 6mg=–16.9±20.7, 9mg=–16.8±21.0, 12mg= –20.6±20.2, 15mg=–19.9±18.4 vs. placebo=–4.8±22.0; p<0.001), as did all PANSS factor scores (p ≤0.001). Response was significantly higher with all paliperidone ER doses vs. placebo (39.8%, 53.2%, 48.2%, 56.7%, 52.7% vs. 27.4%; p<0.001), and PSP scores improved (8.3±17.1, 9.0±14.8, 7.8±14.3, 9.5±15.0, 12.2±15.7 vs. 0.5±15.0, p<0.001). TEAEs occurred in 66–77% of paliperidone ER patients (vs placebo, 66%), with increased extrapyramidal symptom rates with paliperidone ER 9–15mg. In both total paliperidone and placebo groups, 6% of patients had serious TEAEs. Mean bodyweight changes (kg) were 1.0±3.1 for paliperidone ER vs. -0.4±3.5 for placebo. All doses of paliperidone ER were well tolerated, showed significant efficacy and improved personal and social functioning.

This study was supported by Supported from funding from Johnson & Johnson Pharmaceutical Services, LLC and Johnson & Johnson Pharmaceutical Research and Development.