Demonstrated safety and tolerability profile with AUSTEDO1

Similar discontinuation and dose reduction rates vs placebo1,2

  • Discontinuation due to adverse events occurred in 2% of patients in both the AUSTEDO and placebo arms
  • Dose reduction due to adverse events was required in 7% of patients in both the AUSTEDO® (deutetrabenazine) tablets and placebo arms

Adverse Events Reported in ≥4% of Patients Treated With AUSTEDO in the Placebo-controlled Study1,3

Adverse Events
AUSTEDO (n=45)
Placebo (n=45)
Somnolence
11%
4%
Diarrhea
9%
0%
Dry mouth
9%
7%
Fatigue
9%
4%
Urinary tract infection
7%
2%
Insomnia
7%
4%
Irritability
7%
13%
Depression/
Agitated depression
4%
7%
Dizziness
4%
9%
Anxiety
4%
2%
Constipation
4%
2%
Contusion
4%
2%
Fall
4%
9%

Once patients were titrated to their maintenance dose, the following adverse events were no longer reported3:

  • Somnolence
  • Diarrhea
  • Dry mouth
  • Fatigue
  • Adverse events of special interest, including parkinsonism, akathisia, restlessness, and suicidal ideation, were not reported in any patients during titration phase and were reported in ≤4% of patients in both arms during maintenance phase3
  • Anxiety was reported in ≤4% of patients in both arms during titration and maintenance phases3

REFERENCES: 1. AUSTEDO® (deutetrabenazine) tablets current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. 2. Frank S, Testa CM, Stamler D, et al.; Huntington Study Group. Effect of deutetrabenazine on chorea among patients with Huntington disease: a randomized clinical trial. JAMA. 2016;316(1):40-50. 3. Data on file. Parsippany, NJ: Teva Neuroscience, Inc.