Teva announced that a pair of Phase 2/3, Phase 3 trials designed to evaluate Austedo (deutetrabenazine) in Tourette Syndrome failed to meet primary endpoints.
Phase 2/3 ARTISTS 1 and Phase 3 ARTISTS 2 trials evaluated the drug compared to placebo for the treatment of tics in pediatric patients with moderate to severe Tourette Syndrome. Austedo failed significantly reduce motor and phonic tics as assessed by the Total Tic Score of the Yale Global Tic Severity Scale.
Austedo tablets were approved by the FDA for the treatment of chorea associated with Huntington’s disease in April 2017 and for tardive dyskinesia in adults in August 2017.
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