Safety profile in tardive dyskinesia
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
Discontinuation due to side effects was 3% with INGREZZA® (valbenazine) capsules vs 2% with placebo1
Patients in the clinical trials were allowed to remain on their stable psychiatric treatment regimen1:
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
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%)
PSYCHIATRIC STATUS GENERALLY REMAINED STABLE DURING THE KINECT 3 STUDY2
Safety assessments of psychiatric disorders from baseline through 6 weeks3
|Disorder||Observed increase or worsening||Measure|
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.
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.
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.
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.
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 in Simpson-Angus Scale score 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.|
- INGREZZA [package insert]. San Diego, CA: Neurocrine Biosciences, Inc.
- 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.
- Data on file. Neurocrine Biosciences, Inc.
- Marder SR, Singer C, Lindenmayer JP, et al. A phase 3, 1-year, open-label trial of valbenazine in adults with tardive dyskinesia. J Clin Psychopharmacol. 2019;39(6):620-627.