The first and only study to measure patient-reported TD impact using multiple validated scales
Data on file. Neurocrine Biosciences, Inc.
Safety profile in tardive dyskinesia
Demonstrated safety and tolerability profile in the widest range of patients1,2
DATA FROM 3 6-WEEK, CONTROLLED STUDIES (KINECT, KINECT 2, and KINECT 3), INCLUDING POST HOC ANALYSIS
Adverse reactions reported at ≥2% and >placebo through 6 weeks (safety population)1,2
| Adverse Reaction |
INGREZZA (N=262) (%) |
Placebo (N=183) (%) |
|---|---|---|
| Somnolencea | 10.9% | 4.2% |
| Somnolence | 5.3% | 2.2% |
| Fatigue | 4.2% | 1.6% |
| Sedation | 1.2% | 0.6% |
| Anticholinergic effectsa | 5.4% | 4.9% |
| Dry mouth | 3.4% | 1.6% |
| Constipation | 1.2% | 2.7% |
| Disturbance in attention | 0.4% | 0.0% |
| Vision blurred | 0.4% | 0.0% |
| Urinary retention | 0.0% | 0.6% |
| Balance disorders/falla | 4.1% | 2.2% |
| Fall | 1.5% | 0.0% |
| Gait disturbance | 1.2% | 0.0% |
| Dizziness | 0.8% | 1.6% |
| Balance disorder | 0.4% | 0.0% |
| Headache | 3.4% | 2.7% |
| Akathisiaa | 2.7% | 0.5% |
| Akathisia | 2.3% | 0.6% |
| Restlessness | 0.4% | 0.0% |
| Vomiting | 2.6% | 0.6% |
| Nausea | 2.3% | 2.1% |
| Arthralgia | 2.3% | 0.5% |
| a |
Individual preferred adverse terms are separated and their incidence were analyzed based on preliminary and post hoc analyses of data pooled from 3 6-week, controlled studies (KINECT, KINECT 2, KINECT 3); analysis may differ from Prescribing Information and be updated as analyses are finalized. |
PROVEN ACROSS THE WIDEST RANGE OF PATIENTS1,3
Get data-informed dosing recommendations for drug interactions and special populations
Psychiatric safety was generally maintained with INGREZZA
treatment2
PSYCHIATRIC SAFETY ASSESSMENTS IN KINECT 3
Safety assessments of psychiatric disorders from baseline through 6 weeks3
| Disorder | Measure | Observed increase or worsening |
|---|---|---|
| Schizophrenia | PANSSa | No |
| Mania | YMRSb | No |
| Depression | CDSSc, MADRSd | No |
| Suicidal ideation/ behavior |
C-SSRSe | No |
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
| 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 |
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. |
| d |
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. |
| e |
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. |
| f |
40 mg data includes doses of 40 mg and 50 mg; 80 mg data includes doses of 75 mg and 80 mg. |
SEE LONG-TERM SAFETY AND TOLERABILITY WITH INGREZZA
Review results of the KINECT 4 study—a phase 3, long-term, open-label study evaluating the safety and tolerability of once-daily INGREZZA.4
REFERENCES:
- 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.
- Deutrabenazine [package insert]. Parsippany, NJ: Teva Neuroscience, 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.