New Doses for Austedo XR Revolutionize Treatment Options for Movement Disorders

FDA Approves New Strengths of Austedo XR

The U.S. Food and Drug Administration (FDA) has given the green light to four new tablet strengths of Austedo XR for adults. This medication is specifically designed for those diagnosed with tardive dyskinesia and chorea associated with Huntington’s disease.

According to manufacturer Teva Pharmaceuticals, the newly approved tablet strengths include 30 mg, 36 mg, 42 mg, and 48 mg. This is in addition to the previously approved strengths of 6 mg, 12 mg, and 24 mg, making it easier for patients to manage their dosage with just one pill per day.

What is Austedo XR?

Austedo XR (deutetrabenazine) is a type of drug known as a vesicular monoamine transporter 2 inhibitor (VMAT2). It is the first drug of its kind to be approved by the FDA for treating adults with these specific movement disorders. However, its safety and effectiveness in children have not yet been confirmed.

By inhibiting VMAT2, Austedo XR helps reduce involuntary movements, providing significant relief to patients struggling with these conditions.

Benefits of Once-Daily Dosing

Dr. Rakesh Jain, a clinical professor of psychiatry at Texas Tech University School of Medicine, highlighted the significance of this approval. He mentioned that the once-daily dosing could be easily integrated into existing treatment plans for patients, enhancing convenience and compliance.

The streamlined treatment option can lead to improved patient outcomes, making daily management simpler and more effective.

Clinical Trial Results and Efficacy

Clinical trials lasting three years have shown promising results. For those with tardive dyskinesia, improvements in symptoms can be seen as early as two weeks after starting Austedo XR. Similarly, patients with Huntington’s chorea have reported significant reductions in their Total Maximal Chorea (TMC) score.

These trials underscore the drug's potential to bring substantial relief to patients suffering from these debilitating conditions.

Minimal Drug Interaction Concerns

One of the standout features of Austedo XR, and its twice-daily version, Austedo, is the lack of restrictions involving CYP3A4/5 inducers or inhibitors. This means that patients on other medications do not need to worry about complicated drug interactions, providing an added layer of safety and flexibility.

Company Commitment to Patient Care

Since the launch of Austedo in 2017, Teva Pharmaceuticals has remained committed to improving the lives of individuals affected by tardive dyskinesia and Huntington’s disease chorea. Dell Faulkingham, Senior Vice President at Teva, emphasized that these new dosing options offer broad flexibility, making it easier for healthcare providers to tailor treatments to individual needs.

Final Thoughts

The addition of new strengths for Austedo XR could mark a significant milestone in the treatment of movement disorders. With its convenient, once-daily dosing and minimal drug interaction risks, patients are likely to experience better management of their conditions.