Teva announces positive top-line results from a study evaluating SD-809 in tardive dyskinesia

Teva has announced positive top-line results from the pivotal clinical study ARM-TD designed to evaluate the efficacy of SD-809 (deutetrabenazine) in the treatment of moderate to severe tardive dyskinesia.

Tardive dyskinesia is a hyperkinetic movement disorder characterised by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities. The often debilitating disorder affects about 500,000 people in the US alone and is a result of treatment with widely used medications for psychiatric conditions such as schizophrenia and bipolar disease, and certain drugs used for treating various gastrointestinal disorders.

Top-line data showed that the study met its primary endpoint and demonstrated a positive trend in all secondary endpoints. Importantly, the study also showed a favourable safety and tolerability profile, including low rates of depression, somnolence, insomnia and akathisia.

Patients taking SD-809 achieved an improvement of 3.0 points on the AIMS score

The primary endpoint of ARM-TD was the change in the Abnormal Involuntary Movement Scale (AIMS) from baseline to end of therapy. The study results show patients taking SD-809 achieved an improvement of 3.0 points on the AIMS score from baseline to end of therapy compared to 1.6 points in placebo.

Study results also demonstrated a favourable safety and tolerability profile of SD-809. Fewer patients taking SD-809 than placebo experienced serious adverse events (SAEs). For all other side effects reported in the study, rates in the SD-809 group were similar or lower than the placebo group. Further analysis of the additional data from the study is ongoing and details will be shared at future medical meetings.

Tardive dyskinesia is one of the most debilitating of dopamine receptor blocking agents

“SD-809 is an exciting addition to Teva’s CNS portfolio and has the potential to offer a meaningful and much needed therapeutic option to patients suffering from involuntary movements related to a number of disorders. Currently our development programme includes studies in tardive dyskinesia, Huntington’s disease and Tourette syndrome,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “We are committed to developing innovative medicines in this therapeutic area and we are making great progress in bringing a potential new treatment to the patients and their families who can benefit most.”

“These clear and clinically meaningful efficacy and safety results for SD-809 in a rigorously performed global multicentre clinical trial for tardive dyskinesia are very encouraging,” said Hubert Fernandez, M.D., Professor of Neurology at the Center for Neurological Restoration at the Cleveland Clinic and Principal Investigator of the SD-809 ARM-TD clinical study. “There is a serious and growing medical need as tardive dyskinesia is one of the most debilitating and often irreversible side effects of dopamine receptor blocking agents, which are increasingly being used in the United States for various psychiatric disorders and gastrointestinal conditions. With no approved treatments of this serious condition currently available, the need for a therapeutic solution is urgent and overdue.”