FDA Approves Teva's AUSTEDO® XR Once-Daily Tablets

The U.S. Food and Drug Administration (FDA) has recently granted approval for AUSTEDO XR, a new once-daily pill designed for treating tardive dyskinesia (TD) and Huntington’s disease (HD) chorea in adults. This announcement was made by Teva Pharmaceuticals, a subsidiary of Teva Pharmaceutical Industries Ltd. The newly approved medication comes in four tablet strengths: 30, 36, 42, and 48 mg, offering greater dosing flexibility.

AUSTEDO XR, the latest development in a series of treatments launched since 2017, seeks to further improve the management of these chronic conditions. According to Dell Faulkingham, Senior Vice President at Teva, the company has remained committed to finding effective solutions for TD and HD chorea, aiming to provide a streamlined, once-daily treatment regimen that maintains therapeutic efficacy.

The impact of mental illness in the U.S. is substantial, with over 57 million people affected, including 14 million with serious conditions. TD is a significant concern for those on certain mental health medications, affecting roughly one in four patients. This disorder is characterized by involuntary, repetitive movements that can severely impact physical, emotional, and psychological well-being. HD, known for its fatal neurodegenerative effects, results in cognitive decline, behavioral issues, and uncontrolled movements (chorea), affecting 90% of patients. These symptoms make everyday activities like eating, talking, and walking challenging.

Dr. Rakesh Jain, a Clinical Professor of Psychiatry, emphasized the importance of effective and patient-considerate treatments for these disorders. The approval of AUSTEDO XR provides a convenient once-daily option with proven efficacy, as established by clinical trials. Patients with TD can expect symptom improvement in as little as two weeks, while those with HD chorea may see a significant reduction in their Total Maximal Chorea (TMC) score over three years of sustained treatment results.

AUSTEDO XR and its bi-daily counterpart AUSTEDO (deutetrabenazine) are noteworthy as VMAT2 inhibitors without usage restrictions with CYP3A4/5 inducers or inhibitors. This is crucial for patients managing multiple medications. Financially, approximately 90% of insured patients can expect to pay $10 or less for their prescriptions, with Teva providing additional support to ensure access to the medication through reimbursement and patient assistance programs.

Tardive dyskinesia (TD) is a chronic movement disorder affecting one in four people on certain mental health treatments. It's marked by uncontrollable and repetitive movements, which are both disruptive and distressing. Conversely, Huntington’s disease (HD) is a fatal neurodegenerative disorder leading to uncoordinated movements, cognitive decline, and behavioral issues. Chorea, a primary symptom of HD, involves involuntary and random twisting movements, significantly impacting patients' quality of life.

AUSTEDO XR and AUSTEDO are the first VMAT2 inhibitors approved by the FDA to treat TD and HD chorea in adults. However, these medications come with important safety warnings, including risks of depression, suicidality, and potential worsening of mood and cognitive functions. They are contraindicated in patients with untreated depression and various other conditions.

Common adverse reactions include somnolence, diarrhea, dry mouth, and fatigue for HD patients, and nasopharyngitis and insomnia for TD patients. The safety profile of AUSTEDO XR is expected to be similar to its bi-daily counterpart.

Teva Pharmaceuticals continues to innovate in the pharmaceutical sector, leveraging over a century of experience and a robust global network to improve health outcomes. The company remains dedicated to advancing and expanding its portfolio to provide quality medications to patients worldwide.

In conclusion, the approval of AUSTEDO XR marks a significant advancement in the treatment of TD and HD chorea, promising effective symptom management with a convenient once-daily dosing regimen. This development underscores Teva Pharmaceuticals' ongoing commitment to addressing the needs of patients with chronic movement disorders.