The US Food and Drug Administration has granted Austedo® (deutetrabenazine, Teva Pharmaceuticals) approval for the treatment of tardive dyskinesia. The approval marks the second indication for the drug, which was previously approved in April for the treatment of chorea associated with Huntington’s disease.
“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,” Teva chief scientific officer Michael Hayden, MD, PhD, said in a statement, referring to the association of tardive dyskinesia with treatments for psychiatric disorders.
The approval was based on results from 2 pivotal phase 3 trials, ARM-TD (ClinicalTrials.gov identifier: NCT02195700) and AIM-TD (ClinicalTrials.gov identifier: NCT02291861), which demonstrated the superior ability of the drug to reduce involuntary movements compared with placebo. Overall, adverse events were mild to moderate in nature, and more patients who received deutetrabenazine reported their symptoms were “much” or “very much improved” compared with placebo.
Austedo is contraindicated in patients with hepatic impairment, those taking or who recently discontinued reserpine or monoamine oxidase inhibitors, and those taking tetrabenazine or valbenazine. The most common adverse events in patients taking Austedo for tardive dyskinesia are nasopharyngitis and insomnia. Sedation is common and may prevent some patients from reaching the optimal dose of Austedo.
To learn more about the ARM-TD and AIM-TD trials, watch the video below featuring lead investigator Joohi Jimenez-Shahed, MD.
Teva announces FDA approval of AUSTEDO® (deutetrabenazine) tablets for the treatment of tardive dyskinesia in adults [news release]. Jerusalem, Israel: Teva Pharmaceuticals newsroom; August 30, 2017.