Austedo XR Approved: A New Treatment Option for Tardive Dyskinesia and Huntington Disease

Uladzislau/AdobeStock

The US Food and Drug Administration (FDA) has approved Teva Pharmaceuticals’ Austedo XR (deutetrabenazine) as a once-daily pill treatment option, available in 4 new tablet strengths (30, 36, 42, 48 mg), indicated in adults for tardive dyskinesia (TD) and Huntington disease (HD) chorea control.¹

“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 Rakesh Jain, MD, 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."

Austedo XR boasts 3 years of the longest TD and HD chorea clinical trials and sustained results to date.^2-5 According to findings, patients with TD who take Austedo XR can expect symptom improvement in as early as 2 weeks, and patients with HD chorea may experience a significant reduction in Total Maximal Chorea score. Additionally, Austedo XR, as well as twice-daily counterpart Austedo, are the only VMAT2 inhibitor treatments with no restrictions for use with CYP3A4/5 inducers or inhibitors.

“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 US 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.”

TD impacts at least 500,000 individuals in the United States. About 60% to 70% of cases are mild, and about 3% are extremely severe. Patients who have been treated for schizophrenia, schizoaffective disorder, or bipolar disorder are particularly at risk.⁶ In a recent analysis, investigators looked at 41 studies, which included 11,493 participants on antipsychotic medications and demonstrated an overall prevalence of TD in 25.3% of participants. Participants taking first-generation antipsychotics had a 30.0% prevalence of TD, while participants taking second-generation antipsychotics had a 20.7% prevalence of TD. Research like this “serve[s] as a sobering reminder of the significant frequency of this disfiguring and sometimes disabling adverse effect, which can be irreversible.”⁷

In the press release, Teva also committed to making Austedo XR more accessible for patients. The company promised that approximately 90% of patients with insurance are expected to pay $10 or less for their prescription with financial assistance.¹

References

1. Teva announces Austedo® XR (deutetrabenazine) extended-release tablets now U.S. FDA approved as a one pill, once-daily treatment option for clinically therapeutic doses (24–48 mg/day). News release. Accessed May 30, 2024. https://www.tevapharm.com/news-and-media/latest-news/teva-announces-austedo-xr-deutetrabenazine-extended-release-tablets-now-u.s.-fda-approved-as-a-one-pil/

2. Hauser RA, Barkay H, Fernandez HH, et al. Long-term deutetrabenazine treatment for tardive dyskinesia is associated with sustained benefits and safety: a 3-year, open-label extension study. Front Neurol. 2022;13:773999.

3. Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for the treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomized, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4(8):595-604.

4. Fernandez HH, Factor SA, Hauser RA, et al. Randomised controlled trial of deutetrabenazine for tardive dyskinesia: the ARM-TD study. Neurology. 2017;88(21):2003-2010.

5. Marder SR, Singer C, Lindenmayer J-P, et al. A phase 3, 1-year, open-label trial of valbenazine in adults with tardive dyskinesia. J Clin Psychopharmacol. 2019;39(6)620-627.

6. Robert L. Tardive dyskinesia facts and figures. Psychiatric Times. May 30, 2019. https://www.psychiatrictimes.com/view/tardive-dyskinesia-facts-and-figures

7. Osser DN. Use of antipsychotics: risks of tardive dyskinesia. Psychiatric Times. 2022;39(12).