FDA Approves Austedo XR Extended-Release Tablets for Huntington’s Disease

Title: FDA Approves Austedo XR Extended-Release Tablets for Huntington’s Disease


Huntington’s disease is a rare, inherited neurodegenerative disorder that affects the brain and progressively impairs motor control, cognition, and behavior. Treatment options for Huntington’s have historically been limited, but a recent milestone brings new hope for patients and their families. The US Food and Drug Administration (FDA) has approved Austedo XR extended-release tablets for the treatment of Huntington’s disease. In this blog post, we will explore the key points behind Austedo XR and the significance of the FDA’s approval.

Key Points:

  1. Understanding Huntington’s Disease:

Huntington’s disease is caused by a genetic mutation that leads to the death of brain cells over time. Symptoms usually appear in adulthood and include involuntary movements (chorea), cognitive decline, and psychiatric symptoms. The disease progresses gradually, significantly impacting the quality of life for those affected.

  1. Austedo XR Extended-Release Tablets:

Austedo XR (deutetrabenazine) is a medication developed by Teva Pharmaceuticals for the treatment of Huntington’s disease. It belongs to a class of drugs known as vesicular monoamine transporter 2 (VMAT2) inhibitors. By inhibiting VMAT2, Austedo XR helps regulate the levels of certain neurotransmitters in the brain, reducing involuntary movements associated with Huntington’s disease.

  1. FDA Approval:

The FDA’s approval of Austedo XR represents a significant milestone in the treatment of Huntington’s disease. It validates the efficacy and safety of this medication in managing chorea, one of the most distressing symptoms of the disease. It offers individuals with Huntington’s and their healthcare providers a new tool to better manage the motor symptoms associated with the condition.

  1. Extended-Release Formulation:

Austedo XR is an extended-release formulation, designed to provide a continuous and consistent release of the active ingredient over a 24-hour period. This allows for once-daily dosing, reducing the number of tablets patients need to take and enhancing convenience and adherence to the treatment regimen.

  1. Clinical Trial Results:

The FDA’s approval of Austedo XR was based on a robust clinical trial program that demonstrated its efficacy and safety. The trials showed that Austedo XR significantly reduced chorea in patients with Huntington’s disease compared to placebo. Additionally, it was generally well-tolerated, with the most common side effects being sleepiness, fatigue, and diarrhea.

  1. Impact on Huntington’s Disease Management:

The approval of Austedo XR provides new hope for individuals living with Huntington’s disease and their caregivers. By specifically addressing the motor symptoms, it can alleviate some of the challenges associated with the condition, improve quality of life, and enhance the ability to perform daily activities. Moreover, it serves as a crucial step in the development of more targeted therapies for this complex disease.


The FDA’s approval of Austedo XR extended-release tablets marks an important advancement in the treatment of Huntington’s disease. This medication offers a novel approach to managing the debilitating chorea symptoms experienced by patients. By controlling these symptoms, Austedo XR has the potential to significantly improve the lives of those affected by Huntington’s disease, providing hope for a more manageable future. As researchers and pharmaceutical companies continue to explore innovative treatments, there is optimism for further progress in the understanding and management of this challenging neurodegenerative disorder.