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The percentage of subjects who discontinued due to adverse events in the open-label period of the long-term study in subjects with schizoaffective disorder was 7. During the double-blind, placebo-controlled period of that study, the percentages of subjects who discontinued due to adverse events were 5. Based on the pooled data from the four fixed-dose, double-blind, placebo-controlled trials in subjects with schizophrenia, among the adverse reactions that occurred at ? 2% incidence in the subjects treated with INVEGA SUSTENNA’ , only akathisia increased with dose. Hyperprolactinemia also exhibited a dose relationship, but did not occur at ? 2% incidence in INVEGA SUSTENNA’-treated subjects from the four fixed-dose studies. An examination of population subgroups in the double-blind placebo-controlled trials did not reveal any evidence of differences in safety on the basis of age, gender, or race alone; however, there were few subjects ? 65 years of age. Extrapyramidal Symptoms (EPS) Pooled data from the two double-blind, placebo-controlled, 13-week, fixed-dose trials in adult subjects with schizophrenia provided information regarding EPS. Several methods were used to measure EPS: (1) the Simpson-Angus global score (mean change from baseline or score at the end of trial) which broadly evaluates Parkinsonism, (2) the Barnes Akathisia Rating Scale global clinical rating score (mean change from baseline or score at the end of trial) which evaluates akathisia, (3) use of anticholinergic medications to treat EPS, (4) the Abnormal Involuntary Movement Scale scores (mean change from baseline or scores at the end of trial) (Table 11), and (5) incidence of spontaneous reports of EPS (Table 12). Table 11: Extrapyramidal Symptoms (EPS) Assessed by Incidence of Rating Scales and Use of Anticholinergic Medication – Schizophrenia Studies in Adults Percentage of Subjects Scale Placebo (N=262) INVEGA SUSTENNA’ 39 mg (N=130) 78 mg (N=223) 156 mg (N=228) Parkinsonism a 9 12 10 6 Akathisia b 5 5 6 5 Dyskinesia c 3 4 6 4 Use of Anticholinergic Medications d 12 10 12 11 a For Parkinsonism, percent of subjects with Simpson-Angus Total score > 0. Table 12: Extrapyramidal Symptoms (EPS)-Related Events by MedDRA Preferred Term – Schizophrenia Studies in Adults EPS Group Placebo (N=262) Percentage of Subjects INVEGA SUSTENNA’ 39 mg (N=130) 78 mg (N=223) 156 mg (N=228) Overall percentage of subjects with EPS-related adverse events 10 12 11 11 Parkinsonism 5 6 6 4 Hyperkinesia 2 2 2 4 Tremor 3 2 2 3 Dyskinesia 1 2 3 1 Dystonia 0 1 1 2 Parkinsonism group includes: Extrapyramidal disorder, hypertonia, musculoskeletal stiffness, parkinsonism, drooling, masked facies, muscle tightness, hypokinesia Hyperkinesia group includes: Akathisia, restless legs syndrome, restlessness Dyskinesia group includes: Dyskinesia, choreoathetosis, muscle twitching, myoclonus, tardive dyskinesia Dystonia group includes: Dystonia, muscle spasms. The results across all phases of the maintenance trial in subjects with schizophrenia exhibited comparable findings. In the 9-week, fixed-dose, double-blind, placebo-controlled trial, the proportions of Parkinsonism and akathisia assessed by incidence of rating scales were higher in the INVEGA SUSTENNA’ 156 mg group (18% and 11%, respectively) than in the INVEGA SUSTENNA’ 78 mg group (9% and 5%, respectively) and placebo group (7% and 4%, respectively). In the 13-week study in subjects with schizophrenia involving 234 mg initiation dosing, the incidence of any EPS was similar to that of the placebo group (8%), but exhibited a dose-related pattern with 6%, 10%, and 11% in the INVEGA SUSTENNA’ 234/39 mg, 234/156 mg, and 234/234 mg groups, respectively. Hyperkinesia was the most frequent category of EPS-related adverse events in this study, and was reported at a similar rate between the placebo (4. In the long-term study in subjects with schizoaffective disorder, the EPS during the 25-week open-label INVEGA SUSTENNA’ treatment were hyperkinesia (12. During the 15-month double-blind treatment, the incidence of any EPS was similar to that of the placebo group (8. The most commonly reported treatment-emergent EPS-related adverse events ( > 2%) in any treatment group in the double-blind phase of the study (INVEGA SUSTENNA’ versus placebo) were hyperkinesia (3.
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