Teva Wins Breakthrough Therapy Designation for Tardive Dyskinesia Candidate

Teva Pharmaceutical Industries has won the FDA’s breakthrough therapy designation for SD-809 for the treatment of moderate to severe tardive dyskinesia.

An oral, small molecule inhibitor of vesicular monoamine 2 transporter, SD-809 (deutetrabenazine) is designed to regulate the levels of dopamine in the brain. There are currently no approved therapies in the U.S. for tardive dyskinesia, a disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face and extremities.

The Israeli drugmaker’s 117-patient Phase 2/3 study compared SD-809 to placebo for reducing the severity of abnormal involuntary movements associated with tardive dyskinesia. The compound also is being developed for treatment of chorea associated with Huntington’s disease, as well as tics associated with Tourette syndrome.