Safety profile in tardive dyskinesia
Demonstrated safety and tolerability profile in the widest range of patients1,2
ADVERSE REACTIONS BY DOSE IN KINECT 3
Treatment-emergent adverse reactions by dose with incidence ≥2% in all patients with Tardivex and at a higher incidence than placebo during the 6-week treatment period in a pivotal study (safety population)2
| Adverse Reaction | Tardivex 40 mg | Placebo |
|---|---|---|
| (n=72) (%) | (n=76) (%) | |
| Overall | 40.30% | 43.40% |
| Somnolence | 5.60% | 3.90% |
| Akathisia | 4.20% | 1.30% |
| Dry mouth | 6.90% | 1.30% |
| Arthralgia | 1.40% | 1.30% |
| Dyskinesia | 0.00% | 0.00% |
| Vomiting | 0.00% | 0.00% |
| Anxiety | 1.40% | 0.00% |
| Fatigue | 2.80% | 1.30% |
| Weight increase | 1.40% | 0.00% |
| Insomnia | 1.40% | 1.30% |
aP≤0.001 vs placebo; adjusted for multiplicity.
Effect size=0.9.
*Based on modeling and simulation. The LS mean is adjusted for baseline AIMS score and disease category and is shown for consistency with 40 mg and 80 mg observed values from the KINECT 3 study.
AIMS, Abnormal Involuntary Movement Scale; BL, baseline; ITT, intent-to-treat; LS mean, least squares mean; SD, standard deviation; SEM, standard error of mean.
Tardivex pooled safety profile
COMBINED SAFETY ACROSS 3 KEY STUDIES
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%)
Adverse reactions in 3 placebo-controlled studies of a 6-week treatment duration reported at ≥2% and >placebo (safety population)1
| Adverse Reaction | TARDIVEX | Placebo |
|---|---|---|
| (n=262) (%) | (n=183) (%) | |
| Somnolence (somnolence, fatigue, sedation) | 10.90% | 4.20% |
| Anticholinergic effects | 5.40% | 4.90% |
| Balance disorders/fall | 4.10% | 2.20% |
| Headache | 3.40% | 2.70% |
| Akathisia | 2.70% | 0.50% |
| Vomiting | 2.60% | 0.60% |
| Nausea | 2.30% | 2.10% |
| Arthralgia | 2.30% | 0.50% |
SEE LONG-TERM SAFETY AND TOLERABILITY WITH TARDIVEX
Review results of the KINECT 4 study—a phase 3, long-term, open-label study evaluating the safety and tolerability of once-daily Tardivex.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.
- 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.