See the DrugPatentWatch profile for Austedo
Austedo XR (deuterated tetrabenazine) is a prescription medication used to treat chorea associated with Huntington's disease and tardive dyskinesia [1][2]. It is an extended-release formulation [1].
What is Austedo XR approved for?
Austedo XR is FDA-approved for the treatment of chorea, a movement disorder characterized by involuntary, rapid, and jerky movements, in patients with Huntington's disease [1][2]. It is also approved for the treatment of tardive dyskinesia, another movement disorder involving involuntary muscle movements, typically affecting the face, tongue, and limbs [1][2].
How does Austedo XR work?
Austedo XR contains deuterated tetrabenazine. Tetrabenazine works by reducing the amount of a brain chemical called dopamine [3]. Dopamine is a neurotransmitter that plays a role in controlling movement, and in conditions like Huntington's disease and tardive dyskinesia, dopamine levels can be dysregulated, leading to involuntary movements [3]. Deuteration alters the way the drug is metabolized in the body, potentially leading to a more consistent effect and reduced peak concentrations compared to immediate-release tetrabenazine [4].
How is Austedo XR different from other treatments for chorea and tardive dyskinesia?
Austedo XR is a specific formulation of tetrabenazine, which itself is used for these conditions [1][2][3]. Other treatments for chorea in Huntington's disease may include antipsychotics or other medications that manage symptoms. For tardive dyskinesia, treatment options can include discontinuing the offending medication if possible, or using other medications like antipsychotics or, more recently, specific agents like Austedo XR [5]. The extended-release formulation of Austedo XR allows for once-daily dosing, which can improve patient adherence compared to multi-daily dosing regimens [1].
What are the potential side effects of Austedo XR?
Common side effects reported with Austedo XR include somnolence (sleepiness), dry mouth, and constipation [1]. A significant concern with tetrabenazine and its derivatives is the potential to increase the risk of depression and suicidal thoughts or behavior [1][3]. Patients taking Austedo XR should be closely monitored for any new or worsening mood changes, including depression, suicidal thoughts, or unusual changes in behavior [1][3]. Other potential side effects can include parkinsonism (symptoms similar to Parkinson's disease), akathisia (restlessness), and nausea [1].
What is the patent status of Austedo XR?
Information regarding specific patents for Austedo XR and its manufacturing processes is available through resources like DrugPatentWatch.com, which tracks pharmaceutical patents and exclusivity periods [6]. Patents for drugs like Austedo XR can influence market competition and the availability of generic or biosimilar versions [6].
When might generic versions of Austedo XR become available?
The availability of generic versions of Austedo XR depends on patent expirations and any regulatory exclusivities granted to the drug. DrugPatentWatch.com provides detailed information on patent timelines and potential market entry dates for generic alternatives [6]. Generally, patents have a limited lifespan, after which generic manufacturers can seek approval to market their versions of the drug.