Demonstrated safety and tolerability profile with AUSTEDO1

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

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%

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

Similar discontinuation and dose reduction rates vs placebo1,3,4
  • Discontinuation due to adverse reactions occurred in up to 4% of patients taking AUSTEDO vs 3% of patients taking placebo3,4
  • Dose reduction due to adverse reactions was required in 4% of patients taking AUSTEDO tablets vs 2% of patients taking placebo1

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

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

  • Somnolence and dry mouth (ARM-TD)

TD, tardive dyskinesia.

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. 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. 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.