'Tardive dyskinesia causes involuntarily, uncontrollable movements, that can have a significant impact on functioning and emotional well-being of those living with the condition,' said
Three Year Efficacy and Safety of AUSTEDOfor Treatment of TD
The open-label extension of the pivotal ARM-TD and AIM-TD studies evaluated the long-term efficacy and safety of AUSTEDOfor the treatment of TD. Treatment was titrated up to a maximum daily dose of 48 mg based on control of movements and medication tolerability and results were evaluated measuring change from baseline in Abnormal Involuntary Movement Scale (AIMS) scores and Clinical Global Impression of Change (CGIC). The following outcomes were recorded: At Week 54 (n=249; total daily dose [mean+/-SE]: 38.7+/-0.66 mg), mean change from baseline in AIMS score was -4.8+/-0.28, and physician assessments reported 66% of patients met the 'much improved' or 'very much improved' scores on the CGIC.
At Week 106 (n=194; total daily dose: 39.3+/-0.75 mg), mean change from baseline in AIMS score was -5.4+/-0.33, and physician assessments reported 65% of patients met the 'much improved' or 'very much improved' scores on the CGIC.
At Week 145 (n=160; total daily dose: 39.4+/-0.83 mg), mean change from baseline in AIMS score was -6.6+/-0.37, and physician assessments reported 73% of patients met the 'much improved' or 'very much improved' scores on the CGIC.
No new safety signals were identified in this population that were inconsistent with the known safety profile of AUSTEDO.
Long-Term Efficacy and Safety of AUSTEDOIn Patients Severely Impacted by TD
A post hoc analysis of the open-label extension portion of the pivotal ARM-TD and AIM-TD studies evaluated the efficacy of AUSTEDOin reducing TD in the most severely impacted patients. Using the upper quartile of baseline AIMS scores from the open-label extension, two subgroups were defined as having scores >14 or 14. At all-time points from Week two to Week 145, change from baseline in AIMS score was greater in those with baseline AIMS score >14 versus 14 (mean +/-SE at Wk 145: -10.9+/-0.8, -5.1+/-0.3). Percent change from baseline in patients with AIMS score >14 reached -59.4%+/-3.6% versus -55.2%+/-3.1% for patients with AIMS score 14 at Week 145. The percent of patients with 50% AIMS reduction at each visit was 71% in patients with baseline AIMS score >14 versus 64% in patients with AIMS score 14 at Week 145.
No new safety signals were identified in this population that were inconsistent with the known safety profile of AUSTEDO.
Safety and Tolerability of AUSTEDO During Titration and Maintenance
The study evaluated data from the ARM-TD and AIM-TD studies and the open-label extension through week 15 to examine the safety and tolerability of AUSTEDO during titration and maintenance phases of therapy.
For flexible-dose AUSTEDO, the only common AE during titration was somnolence (11.2%); there were no common AEs during maintenance. Rates of specific AEs in titration and maintenance were (ranges for all groups in both periods: parkinsonism, 0-1.4%; suicidal ideation, 0-2.7%; akathisia, 0-1.8%; restlessness, 0-1.4%).
All abstracts presented at
About AUSTEDO (deutetrabenazine)
AUSTEDO is a vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the
AUSTEDO Indications and Usage
AUSTEDO is indicated for the treatment of chorea associated with Huntington's disease and for the treatment of tardive dyskinesia in adults.
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