Safety

In clinical trials, INGREZZA was generally well tolerated across a broad range of tardive dyskinesia patients1,2

INGREZZA safety profile1

Combined safety across 3 key studies

Adverse reactions in 3 placebo-controlled studies of a 6-week treatment duration reported at ≥2% and >placebo (safety population)

INGREZZA® (valbenazine) adverse reactions table INGREZZA® (valbenazine) adverse reactions table
  • Discontinuation due to adverse reactions was 3% with INGREZZA vs 2% with placebo1

Patients in the clinical trials were allowed to remain on their stable psychiatric treatment regimen1,2

  • 85% took second-generation antipsychotics

  • 27% took first-generation antipsychotics

Adverse reactions by dose in KINECT 32,3

Adverse reactions from the phase 3 study (safety population)

Treatment-emergent adverse reactions with incidence ≥3% in all patients treated with INGREZZA and at a higher incidence than placebo during the 6-week treatment period (safety population)

Adverse reactions by dose in KINECT 3 study table Adverse reactions by dose in KINECT 3 study table

The most common types of concomitant medications were2,3:

  • Antipsychotics (85.5%)

  • Antidepressants (66.5%)

  • Anticholinergics (37.0%)

  • Antiepileptics (35.2%)

  • Anxiolytics (27.7%)

  • ACE inhibitors (25.6%)

Mean psychiatric scale scores generally remained stable across the study period3

In the clinical study, patients were evaluated to see the effect of INGREZZA on their existing psychiatric disorders

Safety assessments of psychiatric disorders from baseline through 6 weeks3

Mean psychiatric scale scores table Mean psychiatric scale scores table

Parkinsonism generally remained stable across the study period3

In one 6-week, phase 3, placebo-controlled study, the mean change from baseline on the Simpson-Angus Scale at 6 weeks was:

  • -0.03 for INGREZZA 40 mg
  • -0.04 for INGREZZA 80 mg
  • -0.11 for placebo
a Mean change in Positive and Negative Syndrome Scale (PANSS) total score from baseline at 6 weeks was -0.5 for INGREZZA 40 mg, -0.3 for INGREZZA 80 mg, and ±0.0 for placebo.3 b Mean change in Young Mania Rating Scale (YMRS) total score from baseline at 6 weeks was -0.4 for INGREZZA 40 mg, -1.4 for INGREZZA 80 mg, and +0.5 for placebo.3 c Columbia Suicide Severity Rating Scale (C‐SSRS). Incidence of suicidal ideation or behavior was 5.6% for INGREZZA 40 mg, 2.5% for INGREZZA 80 mg, and 5.3% for placebo.3 d Mean change in Calgary Depression Scale for Schizophrenia (CDSS) total score from baseline at 6 weeks was -0.5 for INGREZZA 40 mg, -0.4 for INGREZZA 80 mg, and -0.1 for placebo.3 e Mean change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline at 6 weeks was ±0.0 for INGREZZA 40 mg, -1.5 for INGREZZA 80 mg, and +1.2 for placebo.3
  • Safety profile

    In clinical trials, INGREZZA was generally well tolerated across a broad range of tardive dyskinesia patients1,2

    INGREZZA safety profile1

    Combined safety across 3 key studies

    Adverse reactions in 3 placebo-controlled studies of a 6-week treatment duration reported at ≥2% and >placebo (safety population)

    INGREZZA® (valbenazine) adverse reactions table INGREZZA® (valbenazine) adverse reactions table
    • Discontinuation due to adverse reactions was 3% with INGREZZA vs 2% with placebo1

    Patients in the clinical trials were allowed to remain on their stable psychiatric treatment regimen1,2

    • 85% took second-generation antipsychotics

    • 27% took first-generation antipsychotics

  • Adverse reactions by dose

    Adverse reactions by dose in KINECT 32,3

    Adverse reactions from the phase 3 study (safety population)

    Treatment-emergent adverse reactions with incidence ≥3% in all patients treated with INGREZZA and at a higher incidence than placebo during the 6-week treatment period (safety population)

    Adverse reactions by dose in KINECT 3 study table Adverse reactions by dose in KINECT 3 study table

    The most common types of concomitant medications were2,3:

    • Antipsychotics (85.5%)

    • Antidepressants (66.5%)

    • Anticholinergics (37.0%)

    • Antiepileptics (35.2%)

    • Anxiolytics (27.7%)

    • ACE inhibitors (25.6%)

  • Safety assessment scales

    Mean psychiatric scale scores generally remained stable across the study period3

    In the clinical study, patients were evaluated to see the effect of INGREZZA on their existing psychiatric disorders

    Safety assessments of psychiatric disorders from baseline through 6 weeks3

    Mean psychiatric scale scores table Mean psychiatric scale scores table

    Parkinsonism generally remained stable across the study period3

    In one 6-week, phase 3, placebo-controlled study, the mean change from baseline on the Simpson-Angus Scale at 6 weeks was:

    • -0.03 for INGREZZA 40 mg
    • -0.04 for INGREZZA 80 mg
    • -0.11 for placebo
    a Mean change in Positive and Negative Syndrome Scale (PANSS) total score from baseline at 6 weeks was -0.5 for INGREZZA 40 mg, -0.3 for INGREZZA 80 mg, and ±0.0 for placebo.3 b Mean change in Young Mania Rating Scale (YMRS) total score from baseline at 6 weeks was -0.4 for INGREZZA 40 mg, -1.4 for INGREZZA 80 mg, and +0.5 for placebo.3 c Columbia Suicide Severity Rating Scale (C‐SSRS). Incidence of suicidal ideation or behavior was 5.6% for INGREZZA 40 mg, 2.5% for INGREZZA 80 mg, and 5.3% for placebo.3 d Mean change in Calgary Depression Scale for Schizophrenia (CDSS) total score from baseline at 6 weeks was -0.5 for INGREZZA 40 mg, -0.4 for INGREZZA 80 mg, and -0.1 for placebo.3 e Mean change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline at 6 weeks was ±0.0 for INGREZZA 40 mg, -1.5 for INGREZZA 80 mg, and +1.2 for placebo.3