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.