Teva Announces Long Term Efficacy and Safety of Deutetrabenazine in European Patients
- RIM-TD open-label extension (OLE) study showed long-term improvement of Tardive Dyskinesia (TD) symptoms from treatment with deutetrabenazine over three years in European patients1
- TD is an involuntary movement disorder that develops in around 15%-25% of patients taking antipsychotic medications for conditions such as schizophrenia, bipolar disorder, and major depressive disorder2,3
- Data presented at the European College of Neuropsychopharmacology Congress (ECNP) in Milan 21-24 September 2024
21st September 2024: Teva Pharmaceutical Industries Ltd has announced that a new analysis from the European cohort of the RIM-TD open-label extension (OLE) study revealed that deutetrabenazine treatment of patients with Tardive Dyskinesia (TD) was associated with long term improvement of TD symptoms. The improvement in symptoms was sustained throughout the three-year study, and deutetrabenazine was well tolerated.1 The data were presented at the European College of Neuropsychopharmacology (ECNP) annual congress in Milan.
TD is a stigmatising and debilitating involuntary movement disorder characterised by repetitive movements of the tongue, lower face, jaw, and limbs, which develops in around 15%-25% of patients receiving antipsychotic medications for conditions such as schizophrenia, bipolar disorder, and major depressive disorder.2,3
TD usually appears after 1-2 years of taking antipsychotic treatment and has a considerable impact on a patients’ functioning and quality of life.4 The condition has a high unmet medical need as limited treatment options are approved in Europe.5
RIM-TD (Reducing Involuntary Movements in Participants with Tardive Dyskinesia) is a three-year study which enrolled patients who had completed one of the two pivotal deutetrabenazine phase 3 studies, ARM-TD6 and AIM-TD.7 Whilst RIM-TD was conducted in both the United States and Europe, the post hoc subgroup analysis focused on patients from the European countries.1
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). The majority of patients achieved treatment success with 65% of patients for CGIC and 56% for PGIC. Deutetrabenazine was generally well tolerated, regardless of which arm of the two Phase 3 trials (treatment or placebo) the patients had previously been treated in.1
Co-author and presenter of the data, Dr Krzysztof Duma, Associate Medical Director, Teva Pharmaceuticals Europe said:
“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. 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.”
“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, M.D. Vice President & Head of Medical Affairs Europe 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.”
Deutetrabenazine has now been evaluated in ARM-TD, AIM-TD as well as RIM-TD, all of which demonstrated that the treatment provides rapid, sustained, and clinically meaningful improvements in motor function in patients with Tardive Dyskinesia.1,6,7
Deutetrabenazine is already approved in the United States and in a number of other markets worldwide.8
References
1. Hauser A. R 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
2. Ricciardi L et al. Treatment Recommendations for Tardive Dyskinesia. The Canadian Journal of Psychiatry /La Revue Canadienne de Psychiatrie 2019, Vol. 64(6) 388-399. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6591749/
3. Citrome et al. Deutetrabenazine for Tardive Dyskinesia: A systematic review of the efficacy and safety profile for this newly approved novel medication—What is the number needed to treat, number needed to harm and likelihood to be helped or harmed? The International Journal of Clinical Practice. 2017;71(11):e13030
4. Waln O, Jankovic J. An update on Tardive Dyskinesia: From phenomenology to treatment. Tremor other Hyperkinet Mov. 2013; 3: tre03-161-4138-1.
5 Takeuchi H, et al. Pathophysiology, prognosis and treatment of tardive dyskinesia. Therapeutic Advances in Psychopharmacology. 2022; 12:20451253221117313.
6. Fernandez H. H. et al. Randomized controlled trial of deutetrabenazine for Tardive Dyskinesia: The ARM-TD study. Neurology (2017). May 23;88(21):2003-2010
7. Anderson A.E. 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). Aug;4(8):595-604.
8. Teva Pharmaceutical Indistries Limited. Dec 2023 United States Securities and Exchange Commission (Q4cdn.Com)
