FDA Approves Austedo for Treatment of Tardive Dyskinesia
Compared to placebo, patients taking Austedo had a statistically significant improvement in Abnormal Involuntary Movement Scale.
Teva announced that the Food and Drug Administration (FDA) has approved Austedo (deutetrabenazine) tablets for the treatment of tardive dyskinesia in adults.
The efficacy of Austedo in the treatment of tardive dyskinesia was established in two Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel group studies (AIM-TD and ARM-TD). The trials included 335 adult ambulatory patients with tardive duskinesia caused by use of dopamine receptor antagonists (ie, antipsychotics, metoclopramide).
Compared to placebo, patients taking Austedo had a statistically significant improvement in Abnormal Involuntary Movement Scale (AIMS), the primary efficacy measure.
Austedo, a vesicular monoamine transporter 2 (VMAT2) inhibitor, was initially approved to treat Huntington's chorea in April 2017. The product is available as 6mg, 9mg, and 12mg strength tablets in 60-count bottles.
Austedo ® website. http://www.austedo.