Teva granted Breakthrough Therapy Designation for SD-809 by FDA

SD-809 — a much-needed treatment option for the tardive dyskinesia patient population.

For SD-809, the designation request included results from Teva’s Phase II/III study, Aim to ReduceMovements in Tardive Dyskinesia (ARM-TD). In the ARM-TD study, SD-809 was compared with placebo for change in Abnormal Involuntary Movement Scale (AIMS) score from baseline to end of therapy.

“The granting of Breakthrough Therapy Designation by the FDA represents significant progress toward advancing the clinical program for SD-809, as a potential, much-needed treatment option for the underserved tardive dyskinesia patient population. We remain excited about studying this innovative compound across a number of indications,” said Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva.

Tardive dyskinesia, for which there are no approved therapies in the US, has been described as a condition characterized by repetitive and uncontrollable movements of the tongue, lips, face, and extremities and has been reported with some widely used medications for psychiatric conditions such as schizophrenia and bipolar disease, as well as with certain drugs used for treating various gastrointestinal disorders.