Teva Pharmaceutical’s investigational drug, SD-809 for the treatment of Tardive Dyskinesia (TD) showed a statistically significant and promising results in its Phase 3 trial.
About the study
The Phase 3 study was a randomized, double-blind, placebo-controlled, parallel group, fixed-dose study of 288 male and female adults with moderate to severe TD. All patients had a total motor AIMS ≥ 6 at screening and were randomized at baseline in a 1:1:1:1 ratio to receive 1 of 3 fixed-dose regimens of SD-809 (12 mg/day, 24 mg/day, 36 mg/day) or placebo.
The study’s primary endpoint was change in Abnormal Involuntary Movement Scale (AIMS) score from baseline to week 12 for 3 fixed doses of SD-809 as compared to placebo. Patients’ abnormal movements were assessed by blinded central video rating.
All doses improved AIMS scores compared to placebo and at week 12, the 24 mg and 36 mg dose groups of SD-809 demonstrated a significant change from baseline based on the modified intent-to-treat population.
At the end of the trial, the AIMS rating improved from baseline by -3.3 points for 36 mg (P
= .001), -3.2 points for 24 mg (P
= .003) and -2.1 for 12 mg (NS), compared to -1.4 in placebo.
Mean scores on the Clinical Global Impression of Change (CGI) improved by -0.5 for 36 mg (P=0.011) and by -0.6 for 24 mg (P
= .002) based on the modified intent-to-treat population
24 mg was superior to placebo (P
= .014); the 36 mg dose was superior to placebo, but did not reach statistical significance (P=0.059).
SD-809 was well tolerated. The frequency of overall adverse events and adverse events leading to withdrawal were similar among all treatment groups.
Teva will present a fuller analysis at an upcoming meeting.
SD-809 (deutetrabenazine) is an oral, small-molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is being developed for the treatment of chorea associated with Huntington disease (HD)
. Teva is also investigating the potential of deutetrabenazine for treating TD.
The FDA granted Breakthrough Therapy Designation for SD-809 for the treatment of TD in November 2015.
About tardive dyskinesia
Tardive dyskinesia (TD) is a hyperkinetic movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities. Currently there is no treatment for TD.