Teva's AUSTEDO XR Receives FDA Approval For Once-Daily Therapy At Therapeutic Doses

(RTTNews) - Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), said that the U.S. Food and Drug Administration 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 tardive dyskinesia and Huntington's disease chorea.

Patients with tardive dyskinesia or TD taking AUSTEDO XR can expect symptom improvement as early as two weeks while patients with Huntington's disease or 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.

Approximately 90% of patients with insurance coverage are expected to pay $10 or less for their prescription with financial assistance offerings.

Tardive dyskinesia (TD) is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals.

Huntington's disease (HD) is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems. Chorea - involuntary, random and sudden, twisting and/or writhing movements - is one of the most striking physical manifestations of Huntington's disease and occurs in approximately 90% of patients. Chorea can have a significant impact on daily activities and progressively limit peoples' lives.

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