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) (%) |
|---|---|---|
| Somnolence | 10.9% | 4.2% |
| Somnolencea | 5.3% | 2.2% |
| Fatiguea | 4.2% | 1.6% |
| Sedationa | 1.2% | 0.6% |
| Anticholinergic effects | 5.4% | 4.9% |
| Dry moutha | 3.4% | 1.6% |
| Constipationa | 1.2% | 2.7% |
| Disturbance in attentiona | 0.4% | 0.0% |
| Vision blurreda | 0.4% | 0.0% |
| Urinary retentiona | 0.0% | 0.6% |
| Balance disorders/fall | 4.1% | 2.2% |
| Falla | 1.5% | 0.0% |
| Gait disturbancea | 1.2% | 0.0% |
| Dizzinessa | 0.8% | 1.6% |
| Balance disordera | 0.4% | 0.0% |
| Headache | 3.4% | 2.7% |
| Akathisia | 2.7% | 0.5% |
| Akathisiaa | 2.3% | 0.6% |
| Restlessnessa | 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. |
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 |
| 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. |
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.
- Data on file. Neurocrine Biosciences, Inc.
- 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.