Demonstrated safety and tolerability profile with AUSTEDO1

Similar discontinuation and dose reduction rates vs placebo1-3

  • Discontinuation due to adverse reactions occurred in up to 4% of patients taking AUSTEDO vs 3% of patients taking placebo
  • Dose reduction due to adverse reactions was required in 4% of patients taking AUSTEDO® (deutetrabenazine) tablets vs 2% of patients taking placebo

Adverse Reactions Reported in ≥2% of Patients Treated With AUSTEDO in TD Studies1,4

Adverse Reaction
AUSTEDO (n=279)
Placebo (n=131)
Headache
5%
8%
Somnolence
4%
7%
Diarrhea
4%
4%
Nasopharyngitis
4%
2%
Fatigue
4%
5%
Insomnia
4%
1%
Anxiety
4%
5%
Upper respiratory tract infection
3%
4%
Dry mouth
3%
5%
Nausea
2%
7%
Weight increased
2%
3%
Urinary tract infection
2%
2%
Depression/
Dysthymic disorder
2%
1%
Akathisia/Agitation/
Restlessness
2%
1%
Arthralgia
2%
1%

Once patients were titrated to their maintenance dose, the following adverse events were no longer reported4:

  • Dry mouth, nausea, hypertension (AIM-TD)

  • Somnolence and dry mouth (ARM-TD)

TD, tardive dyskinesia.

REFERENCES: 1. AUSTEDO® (deutetrabenazine) tablets current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. 2. Fernandez HH, Factor SA, Hauser RA, et al. Randomized controlled trial of deutetrabenazine for tardive dyskinesia: the ARM-TD study. Neurology. 2017;88(21):2003-2010. 3. Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4(8):595-604. 4. Data on file. Parsippany, NJ: Teva Neuroscience, Inc.