Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, today announced that the U.S. Food and Drug Administration (FDA) has approved AUSTEDO XR as a one pill, once-daily treatment option, now with four new tablet strengths (30, 36, 42, 48 mg) indicated in adults for TD and HD chorea.
“Since our launch of AUSTEDO in 2017, we have been committed to helping people living with TD and HD chorea treat these chronic, involuntary movements,” said Dell Faulkingham, Senior Vice President, Head of U.S. Innovative Medicines at Teva. “AUSTEDO, backed by the longest efficacy and tolerability data to date, has continued to evolve – having received approval for AUSTEDO XR, our once-daily extended-release formulation in February 2023. This latest milestone offers a streamlined treatment regimen for clinically therapeutic doses with the broadest dosing flexibility.”
Currently more than 57 million Americans are living with a mental illness, 14 million of whom are living with a serious mental health condition. For those taking certain mental health medications, one in four may experience the onset of TD, an often-overlooked chronic movement disorder that can have a physical, emotional and psychological impact on patients. HD is a fatal neurodegenerative disease characterized by cognitive deterioration, behavior and/or psychological problems and uncoordinated and uncontrollable movements known as chorea – a symptom that affects 90% of patients. Both conditions can pose significant challenges to patients’ everyday lives as simple tasks like eating, talking and walking can be impacted.
“Knowing patients living with TD and HD chorea are also managing other underlying concomitant conditions, it is important that treatment options for these chronic movement disorders are not only effective, but keep the patient experience in mind,” said Dr. Rakesh Jain, Clinical Professor of Psychiatry, Texas Tech University School of Medicine. “This latest AUSTEDO XR approval provides patients with the same proven efficacy, but now with the convenience of a one pill, once-daily option for clinically therapeutic doses as established by the pivotal clinical trials to help control involuntary movements that can make carrying out basic daily activities difficult.”
Patients with TD taking AUSTEDO XR can expect symptom improvement as early as two weeks while patients with HD chorea may experience a significant reduction in TMC score, with three years of the longest TD and HD chorea clinical trials and sustained results to date. AUSTEDO XR, along with its twice-daily counterpart, AUSTEDO (deutetrabenazine), are the only VMAT2 inhibitor treatments with no restrictions for use with CYP3A4/5 inducers or inhibitors, an important consideration for patients who take a variety of concomitant medications to manage their underlying conditions.
