Safety

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

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)1

Adverse Reaction INGREZZA
(n=262) (%)
Placebo
(n=183) (%)
Somnolence 10.9% 4.2%
Anticholinergic effects 5.4% 4.9%
Balance disorders/fall 4.1% 2.2%
Headache 3.4% 2.7%
Akathisia 2.7% 0.5%
Vomiting 2.6% 0.6%
Nausea 2.3% 2.1%
Arthralgia 2.3% 0.5%

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

Patients in the clinical trials were allowed to remain on their stable psychiatric treatment regimen.1,2

  • 85% took second-generation antipsychotics
  • 27% took first-generation antipsychotics

Adverse reactions by dose in KINECT 3

Treatment-emergent adverse reactions with incidence ≥2% in all patients treated with INGREZZA and at a higher incidence than placebo during the 6-week treatment period in a pivotal study (safety population)2

Adverse
Reaction
ALL INGREZZA treated (n=151)
(%)
INGREZZA 40 mg
(n=72) (%)
INGREZZA 80 mg
(n=79) (%)
Placebo
(n=76) (%)
Overall 45.7% 40.3% 50.6% 43.4%
Somnolence 5.3% 5.6% 5.1% 3.9%
Akathisia 3.3% 4.2% 2.5% 1.3%
Dry mouth 3.3% 6.9% 0.0% 1.3%
Arthralgia 2.6% 1.4% 3.8% 1.3%
Dyskinesia 2.0% 0.0% 3.8% 0.0%
Vomiting 2.0% 0.0% 3.8% 0.0%
Anxiety 2.0% 1.4% 2.5% 0.0%
Fatigue 2.0% 2.8% 1.3% 1.3%
Weight increase 2.0% 1.4% 2.5% 0.0%
Insomnia 2.0% 1.4% 2.5% 1.3%

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 (25.1%)

Mean psychiatric scale scores generally remained stable across the study period2

Safety assessments of psychiatric disorders from baseline through 6 weeks3

Disorder Mean score increased
or worsened
Measure
Schizophrenia No PANSSa
Mania No YMRSb
Suicidal ideation/behavior No C-SSRSc
Depression No CDSS,d MADRSe
  • a Mean change in Positive and Negative Syndrome Scale (PANSS) total score from baseline at 6 weeks was -0.4 for INGREZZA 40 mg, -0.8 for INGREZZA 80 mg, and ±0.0 for placebo.
  • 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.
  • c Incidence of suicidal ideation or behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) was 5.6% for INGREZZA 40 mg, 2.5% for INGREZZA 80 mg, and 5.3% for placebo.
  • 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.
  • 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.

Drug-induced parkinsonism across the study period, as measured by the Simpson-Angus Scale3

In the 3 placebo-controlled clinical studies in patients with TD, the incidence of parkinson-like adverse events was 3% of patients treated with INGREZZA and <1% of patients treated with placebo. The mean change from baseline at 6 weeks across studies was1,3,f:

  • 0.0 for INGREZZA 40 mg
  • −0.1 for INGREZZA 80 mg
  • −0.1 for placebo
  • f 40 mg data include doses of 40 mg and 50 mg; 80 mg data include doses of 75 mg and 80 mg.

REFERENCES: 1. INGREZZA [package insert]. San Diego, CA: Neurocrine Biosciences, Inc; 2020. 2. Hauser RA, Factor SA, Marder SR, et al. KINECT 3: a phase 3 randomized, double-blind, placebo-controlled trial of valbenazine for tardive dyskinesia. Am J Psychiatry. 2017;174(5):476-484. 3. Data on file. Neurocrine Biosciences, Inc.