The US Food and Drug Administration (FDA) has approved deutetrabenazine for the treatment of tardive dyskinesia (TD) in adults, Teva Pharmaceutical Industries announced today.
Deutetrabenazine, marketed as Austedo, was approved in April 2017 for the treatment of chorea associated with Huntington’s disease. The approval as a TD treatment comes less than 5 months after valbenazine became the first drug approved as a treatment for the movement disorder.
“We are pleased to bring forward this second indication for Austedo to treat the underserved tardive dyskinesia population,” said Michael Hayden, MD, PhD, president of global R&D and chief scientific officer at Teva. “We believe physicians treating tardive dyskinesia will appreciate the therapy’s dosing flexibility and the ability to focus on directly treating the movement disorder and not disrupt the ongoing treatment for the underlying condition.”
Deutetrabenazine, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, received Breakthrough Therapy designation for the treatment of TD from the FDA in November 2015.
The approval was based on results from two Phase III studies, AIM-TD and ARM-TD.
Adverse effects of deutetrabenazine include akathisia, agitation, restlessness, sedation, nasopharyngitis, and insomnia.