Demonstrated safety and tolerability profile with AUSTEDO1

Adverse Events Reported in ≥4% of Patients Treated With AUSTEDO in the Placebo-controlled Study1,2

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%

Patients in the pivotal studies received the AUSTEDO BID formulation. Adverse events with AUSTEDO XR are expected to be similar to AUSTEDO BID.1,3

Once patients were titrated to their maintenance dose, the following adverse events were no longer reported2:

  • Somnolence
  • Diarrhea
  • Dry mouth
  • Fatigue
Similar discontinuation and dose reduction rates vs placebo1,4
  • Discontinuation due to adverse events occurred in 2% of patients in both the AUSTEDO and placebo arms1,4
  • Dose reduction due to adverse events was required in 7% of patients in both the AUSTEDO® (deutetrabenazine) tablets and placebo arms1,4
  • 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 phase2
  • Anxiety was reported in ≤4% of patients in both arms during titration and maintenance phases2

REFERENCES: 1. AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. 2. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 3. Frank S, Testa C, Edmondson MC, et al. The safety of deutetrabenazine for chorea in Huntington disease: an open-label extension study. CNS Drugs. 2022;36(11):1207-1216. 4. 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.