Austedo XR Clinical Trial Data
Austedo XR (deutetrabenazine) has undergone clinical trials to establish its efficacy and safety in treating chorea associated with Huntington's disease and tardive dyskinesia.
What Was the Safety and Efficacy of Austedo XR in Huntington's Disease Trials?
The efficacy of Austedo XR in Huntington's disease was evaluated in the ARM-TD study, a Phase 3, randomized, double-blind, placebo-controlled trial. This trial enrolled 90 participants with Huntington's disease and chorea. The primary endpoint was the change from baseline in the Unified Huntington's Disease Rating Scale (UHDRS) total motor score at week 12. Austedo XR demonstrated a statistically significant improvement in motor function compared to placebo [1].
In terms of safety, common adverse events observed in the ARM-TD study included somnolence, nasopharyngitis, and fatigue. The incidence of serious adverse events was similar between the Austedo XR and placebo groups [1].
What Did Clinical Trials Show About Austedo XR for Tardive Dyskinesia?
The efficacy of Austedo XR in tardive dyskinesia was primarily demonstrated in the AIM-TD study, a Phase 3, randomized, double-blind, placebo-controlled trial that included approximately 220 participants. The study met its primary endpoint, showing a statistically significant reduction in the Abnormal Involuntary Movement Scale (AIMS) score for Austedo XR compared to placebo at week 12. This indicated a reduction in the severity of involuntary movements characteristic of tardive dyskinesia [2].
Adverse events reported in the AIM-TD study were generally consistent with those seen in the Huntington's disease trials. The most frequent adverse events included somnolence, headache, and nasopharyngitis. Patients taking Austedo XR also showed a higher incidence of depression and anxiety compared to placebo [2].
How Does Austedo XR Differ from Immediate-Release Tetrabenazine?
Austedo XR is a deuterium-modified form of tetrabenazine, designed for extended-release. This modification allows for less frequent dosing. Clinical trials have suggested that Austedo XR may offer a different tolerability profile compared to immediate-release tetrabenazine, potentially due to its pharmacokinetic properties [3]. Specifically, the extended-release formulation aims to provide more stable drug levels, which may impact side effect profiles.
When Does Austedo XR Patent Protection End?
Patent information for Austedo XR, like other pharmaceuticals, is complex and can involve multiple patents covering the drug substance, formulations, and methods of use. Information on patent expiry dates and potential challenges can be found through resources that track drug patents. For detailed insights into Austedo XR's patent landscape, DrugPatentWatch.com offers comprehensive data [4].