Teva Reports Long-Term Efficacy and Safety of Deutetrabenazine in European Tardive Dyskinesia Patients

Teva Pharmaceutical Industries Ltd. recently disclosed findings from the European segment of the RIM-TD open-label extension (OLE) study, highlighting the long-term effectiveness and tolerance of deutetrabenazine in treating Tardive Dyskinesia (TD). The study's results were showcased at the European College of Neuropsychopharmacology (ECNP) Congress in Milan. TD is a distressing movement disorder affecting 15%-25% of individuals on antipsychotic drugs, used for conditions like schizophrenia and bipolar disorder.

The RIM-TD study spans three years and includes participants who had completed either of the pivotal phase 3 studies, ARM-TD or AIM-TD. While conducted in both the U.S. and Europe, this particular analysis focused on European patients. TD is marked by involuntary, repetitive movements of the face, tongue, jaw, and limbs, significantly impacting patients' quality of life. It typically manifests after 1-2 years of antipsychotic medication use. Despite its prevalence, effective treatment options in Europe are scarce.

Treatment effectiveness in the study was categorized as 'much improved' or 'very much improved' based on the Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC) scales. The outcomes showed that 65% of patients experienced significant improvement as per CGIC, and 56% as per PGIC. Deutetrabenazine was generally well tolerated across both groups from the phase 3 trials.

Dr. Krzysztof Duma, Associate Medical Director at Teva Pharmaceuticals Europe, emphasized the challenge of diagnosing and treating TD. He noted that management often involves reducing antipsychotic dosages, which can exacerbate the underlying psychiatric condition, leading to higher hospitalization rates. The positive results in the European cohort align with findings from other geographical segments, reinforcing deutetrabenazine as a promising treatment.

Pinar Kokturk, M.D., Vice President & Head of Medical Affairs Europe at Teva, expressed concern over the inadequate management of TD in Europe. Despite using various treatments, the lack of robust clinical evidence and the off-label use of these treatments highlight a significant unmet need. Kokturk stressed the necessity for better management guidelines and standardized care for TD patients.

Deutetrabenazine, a selective reversible vesicular monoamine transporter type 2 (VMAT2) inhibitor, has demonstrated rapid and sustained improvements in motor function for TD patients across multiple studies, including ARM-TD and AIM-TD. VMAT2 inhibitors work by depleting neuroactive peptides, such as dopamine, and are used to mitigate dyskinesias caused by antipsychotic medications.

In summary, the RIM-TD open-label extension study provides compelling evidence that deutetrabenazine offers long-term improvement in TD symptoms and is well-tolerated, addressing a significant gap in TD treatment options in Europe. The findings underscore the need for enhanced treatment protocols and standardized care practices to improve the quality of life for TD patients.