Deutetrabenazine Shows Long Term Efficacy and Safety in Patients with Tardive Dyskinesia

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A new analysis from the European cohort of the Reducing Involuntary Movements in Participants with Tardive Dyskinesia (RIM-TD) open-label extension study revealed that treatment with deutetrabenazine was associated with long term improvement of symptoms of tardive dyskinesia (TD). Symptom improvement with deutetrabenazine was sustained throughout the 3 years of the study and the treatment was well tolerated.¹

RIM-TD enrolled patients who had completed 1 of the 2 pivotal deutetrabenazine phase 3 studies: ARM-TD and AIM-TD.^2,3 Whilst RIM-TD was conducted in both the United States and Europe, the post hoc subgroup analysis focused on patients from the European countries, where there is a large unmet need.Investigators presented data at the European College of Neuropsychopharmacology annual congress in Milan.⁴

“Tardive dyskinesia can cause great distress to patients and may be correlated with more severe symptoms and worse outcomes in patients with schizophrenia,” said Pinar Kokturk, MD, vice president and head of European medical affairs at Teva. “Management of tardive dyskinesia is sadly not optimal. Across Europe, guidelines for the management of TD are scarce or missing and there is no standard of care. Despite several treatments used in Europe, the majority have poor clinical evidence and are used off-label and there remains a high unmet need in the treatment of TD. This must change.”

Treatment success was defined as ‘much improved’ or ‘very much improved’ on the Clinical Global Impression of Change (CGIC) or Patient Global Impression of Change (PGIC). Approximately 65% of patients for CGIC and 56% for PGIC achieved treatment success. Deutetrabenazine was generally well tolerated, regardless of whether they received treatment or placebo in the 2 previous phase 3 trials.⁴

“Tardive dyskinesia is a complex disorder that is difficult to treat and remains broadly underdiagnosed. Treating this condition still often results in dose reductions of antipsychotic medication that can impact the underlying psychiatric condition and lead to higher hospitalisation rates,” said Krzysztof Duma, coauthor and presenter of the data, and associate medical director at Teva Pharmaceuticals Europe. “The positive outcome of the study in the European cohort is similar to what we have observed in the overall and US population and gives us further evidence that deutetrabenazine can provide an effective treatment option.”

Data demonstrate that deutetrabenazine provides rapid, sustained, and clinically meaningful improvements in motor function in patients with TD.^2-4

References

1. Teva announces long term efficacy and safety of deutetrabenazine in European patients with debilitating movement disorder tardive dyskinesia. Teva. September 23, 2024. Accessed September 24, 2024. https://www.tevausa.com/news-and-media/press-releases/teva-announces-long-term-efficacy-and-safety-of-deutetrabenazine-in-european-patients-with-debilitating-m/

2. Fernandez HH, Factor SA, Hauser RA, et al. Randomized controlled trial of deutetrabenazine for tardive dyskinesia: the ARM-TD study. Neurology. 2017;88(21):2003-2010.
3. Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4(8):595-604.

4.Hauser AR, et al. Long-term efficacy and safety of deutetrabenazine in a European cohort of the RIM-TD open-label extension study. Presented at European College of Neuropsychopharmacology (ECNP) 21 Sept-24 Sept 2024, Milan. P2154.