FDA Approves One Pill, Once-Daily Tablets of Deutetrabenazine for Tardive Dyskinesia, Chorea

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The newly added tablet strengths allow for greater flexibility when selecting or adjusting dosing for deutetrabenazine.

Dell Faulkingham, senior vice president, and head of Innovative Medicines at Teva

Dell Faulkingham

The FDA has approved a new one-pill, once-daily tablet administration option for deutetrabenazine (Austedo XR; Teva Pharmaceuticals), a medication for tardive dyskinesia and chorea associated with Huntington disease (HD). Deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, is now available in 4 tablet strengths (30, 36, 42, and 48 mg), adding on to its original dosing options of 6 mg, 12 mg, and 24 mg.1

The medication was originally approved as a twice-daily treatment for chorea associated with HD in April 2017 and later had its label expanded in August 2017 to include the treatment of tardive dyskinesia. In February 2023, the FDA approved a once-daily, extended-release formulation of the agent, further allowing for more administration flexibility and improved adherence.2

"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,” Dell Faulkingham, senior vice president, and head of Innovative Medicines at Teva, said in a statement.1 "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."

Deutetrabenazine, both in its original formulation and extended-release option, was the first VMAT2 inhibitor approved by the FDA for the treatment of tardive dyskinesia and chorea associated with HD. The 2023 approval was backed by data from a phase 3 open-label, single-arm 2-cohort, multicenter ARC-HD extension study (NCT01897896) which showed that deutetrabenazine was safe and enhanced and maintained chorea in patients with HD over a 3-year period.3

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In the study, treatment with deutetrabenazine resulted in a mean Total Maximal Chorea (TMC) score decrease of –4.5 points (SD, 3.1; 95% CI, –5.2 to –3.7) for those who completed the double-blind First-HD trial (NCT01795859), termed the rollover cohort (n = 82), and a decrease of –2.1 points (SD, 3.3; 95% CI, –3.1 to –1.0) for those who converted overnight from a stable tetrabenazine dose (switch arm, n = 37) from baseline to week 8. In both the rollover and switch cohorts, mean motor scores decreased from baseline by –7.1 points (SD, 7.3; 95% CI, –8.8 to –5.5) and –2.4 points (SD, 8.7; 95% CI, –5.4 to 0.5), respectively.

Deutetrabenazine’s approval in February 2023 allowed for 3 tablet strengths: 6 mg, 12 mg, and 24 mg, all of which could be administered with or without food. The therapy is currently the only VMAT2 inhibitor on market with no restrictions for use with CYP3A4/5 inducers or inhibitors. It remains contraindicated for patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine or valbenazine.

"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," Rakesh Jain, PhD, MS, clinical professor of psychiatry at the Texas Tech University School of Medicine, said in a statement.1 "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."

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. Teva Pharmaceuticals. May 29, 2024. Accessed May 29, 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. Teva Announces FDA Approval of AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, a New Once-Daily Formulation of AUSTEDO® (deutetrabenazine) Tablets. News release. Teva. February 17, 2023. Accessed May 29, 2024. https://www.businesswire.com/news/home/20230217005357/en/Teva-Announces-FDA-Approval-of-AUSTEDO%C2%AE-XR-deutetrabenazine-Extended-Release-Tablets-a-New-Once-Daily-Formulation-of-AUSTEDO%C2%AE-deutetrabenazine-Tablets
3. Teva announces results from 3-year study assessing the safety and tolerability of Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease. News release. October 18, 2022. Accessed May 29, 2024. https://www.businesswire.com/news/home/20221018005197/en/Teva-Announces-Results-from-3-Year-Study-Assessing-the-Safety-and-Tolerability-of-AUSTEDO%C2%AE-deutetrabenazine-Tablets-for-the-Treatment-of-Chorea-Associated-with-Huntington%E2%80%99s-Disease
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