See the DrugPatentWatch profile for Austedo
Austedo XR is a medication approved for the treatment of chorea associated with Huntington's disease [1]. It is a once-daily formulation of deutetrabenazine, which is a deuterium-deuterated analog of tetrabenazine [2].
How does Austedo XR work for Huntington's Disease?
Austedo XR works by reducing the amount of dopamine, a neurotransmitter, in the brain [3]. Dopamine is involved in regulating movement, and in Huntington's disease, its dysregulation contributes to involuntary movements like chorea [4]. By depleting dopamine, Austedo XR helps to control these movements [3].
When was Austedo XR approved and for what specific use?
Austedo XR received FDA approval for the treatment of chorea associated with Huntington's disease in August 2022 [1]. This approval expanded the treatment options for patients experiencing this symptom of the neurodegenerative disorder [1].
What is the difference between Austedo and Austedo XR?
Austedo XR is a once-daily formulation, whereas the original Austedo (deutetrabenazine) was taken twice daily [1, 2]. This change in dosing frequency aims to improve patient convenience and adherence to treatment [1]. Both formulations contain deutetrabenazine and work on the same mechanism of action to manage chorea [2, 3].
How does Austedo XR compare to other Huntington's disease treatments?
Tetrabenazine, the precursor to deutetrabenazine, is also approved for chorea in Huntington's disease. Deutetrabenazine (Austedo and Austedo XR) was developed to offer a longer half-life and potentially a more consistent plasma concentration compared to tetrabenazine, which may translate to improved tolerability and efficacy for some patients [4]. Other symptomatic treatments may focus on managing other aspects of the disease, but Austedo XR specifically targets chorea [4].
What are the potential side effects of Austedo XR?
Common side effects associated with Austedo XR can include somnolence (sleepiness), dry mouth, and constipation [1]. A significant concern with drugs in this class is the potential for depression and suicidal ideation, as well as neuroleptic malignant syndrome (NMS), a rare but serious reaction [3]. Patients should be closely monitored for these adverse effects [3].
Who manufactures Austedo XR?
Austedo XR is manufactured by Teva Pharmaceuticals [1].
What is the patent status for Austedo XR?
Information regarding specific patent expiry dates for Austedo XR can be found on resources like DrugPatentWatch.com [5]. Patents for drugs are crucial for market exclusivity, and their expiry often signals the potential for generic or biosimilar competition [5].
What clinical data supports Austedo XR's use in Huntington's Disease?
The approval of Austedo XR was based on clinical studies evaluating deutetrabenazine, including its once-daily formulation [1]. These studies demonstrated a significant reduction in chorea severity compared to placebo in patients with Huntington's disease [4].
What are the risks of stopping Austedo XR abruptly?
Stopping Austedo XR suddenly can lead to a worsening of chorea symptoms [3]. Additionally, abrupt discontinuation could potentially increase the risk of other serious adverse events [3]. Therefore, any cessation of treatment should be done under the guidance of a healthcare professional [3].
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Sources
1. "Austedo XR (deutetrabenazine) approved for Huntington’s disease chorea." Teva Pharmaceuticals, 26 Aug. 2022. https://www.tevapharm.com/news/austedo-xr-deutetrabenazine-approved-for-huntingtons-disease-chorea/
2. "FDA approves Austedo XR™ (deutetrabenazine) extended-release tablets, a new once-daily treatment for chorea associated with Huntington’s disease." Teva Pharmaceuticals, 26 Aug. 2022. https://www.tevapharm.com/news/fda-approves-austedo-xr-deutetrabenazine-extended-release-tablets-a-new-once-daily-treatment-for-chorea-associated-with-huntingtons-disease/
3. "Austedo XR (deutetrabenazine) Tablets." U.S. Food & Drug Administration, 11 Oct. 2022. https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-label-changes-2022
4. "Deutetrabenazine for the treatment of chorea associated with Huntington disease." National Institutes of Health, U.S. National Library of Medicine, ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02760738
5. "Drug Patents and Exclusivity." DrugPatentWatch.com. https://drugpatentwatch.com/