FDA Approves Once-Daily Austedo XR for Tardive Dyskinesia and Chorea Associated with Huntington Disease

The Food and Drug Administration (FDA) has approved Austedo XR (deutetrabenazine; Teva Neuroscience, Kansas City, MO) extended-release tablets, a new once-daily formulation of Austedo for the treatment of tardive dyskinesia (TD) and chorea associated with Huntington disease (HD) in adults. Austedo XR is now available in four tablet strengths: 30 mg, 36 mg, 42 mg, and 48 mg. 

According to a company statement, patients with TD taking Austedo XR can expect symptom improvement as early as 2 weeks, while those with chorea associated with HD may experience a significant reduction in Total Maximal Chorea (TMC) score. The new formulation may help improve treatment adherence and simplify medication management for patients with TD and chorea associated with HD. Through the Teva Shared Solutions program, the company provides support to patients and providers through access, affordability, and adherence strategies.

"This latest Austedo XR approval provides patients with the same proven efficacy, but now with the convenience of a once-daily option for clinically therapeutic doses," said Rakesh Jain, MD, Clinical Professor of Psychiatry at Texas Tech University School of Medicine.