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Positive and negative syndrome scale (PANSS)

Primary endpoint : Statistically significant PANSS total score reductions shown vs placebo for both doses from baseline to Day 57.1,3 The study was not designed to evaluate a difference between PERSERIS dosage strengths.

Change in PANSS total scores1,3

Graph depicting the least squares mean change from baseline over 57 days.

See full image description of Change in PANSS total scores1,3 + -

This graph depicts the least squares mean change from baseline achieved by patients receiving PERSERIS 90 mg, PERSERIS 120 mg, and placebo on Days 1 and 29, over the course of 57 days. By Day 57, patients receiving PERSERIS 90/120 mg achieved statistically significant improvement compared to placebo.

Average change in PANSS total scores from baseline1

Graph depicting the average change in PANSS total scores from baseline.

See full image description of Average change in PANSS total scores from baseline1 + -

This graph depicts the average reduction in PANSS scores from baseline for patients receiving placebo (13.37) versus PERSERIS 90 mg (19.86) and PERSERIS 120 mg (23.61).

PERSERIS was studied in adult patients experiencing acute exacerbations of schizophrenia1

Study description: An 8-week, Phase III, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of PERSERIS (90 mg and 120 mg) compared with placebo in 337 inpatients.1

Selected inclusion criteria1 +

  • Mean ages were 40 to 43 (trial included patients aged 18 to 55)1
  • Adult patients experiencing acute exacerbations of schizophrenia1
  • Already hospitalized (or placed in an inpatient setting)1

Trial included patients who had an average Positive and Negative Syndrome Scale (PANSS) baseline score of 80 to 120. Patients had an average PANSS baseline score of 94-96 at screening.1

Average PANSS total score of patients in trial1,4

Graph depicting the average PANSS total score of patients taking part in the clinical trial.

See full image description of Average PANSS total score of patients in trial1,4 + -

This graph depicts the average PANSS total score of patients in the trial. Total PANSS scores range from 0-125, with 58 to 74 considered mild, 75 to 95 considered moderate, 96 to 115 considered marked, and scores equal to or greater than 116 considered severe. In this study baseline scores ranged from 80-120.