FDA Greenlights Once-Daily Deutetrabenazine for Movement Disorders

Introduction to Deutetrabenazine

The FDA has recently approved a new once-daily tablet for deutetrabenazine, marketed as Austedo XR by Teva Pharmaceuticals. This medication is designed to treat tardive dyskinesia and chorea associated with Huntington's disease (HD), offering a more convenient treatment option.

Expanded Tablet Strengths for Enhanced Flexibility

Previously available in doses of 6 mg, 12 mg, and 24 mg, deutetrabenazine can now be taken in four additional tablet strengths: 30 mg, 36 mg, 42 mg, and 48 mg. This range of dosing options aims to improve patient adherence and flexibility in managing their treatment.

History of Deutetrabenazine Approvals

Initially approved in April 2017 for treating chorea associated with HD, deutetrabenazine received approval for treating tardive dyskinesia later that year. The latest once-daily, extended-release formulation, approved in February 2023, marks a significant milestone, providing enhanced administration flexibility and improved adherence.

Supporting Clinical Data

The 2023 approval was based on data from a phase 3 open-label, single-arm, multicenter study (NCT01897896). This study demonstrated that deutetrabenazine was both safe and effective in managing chorea symptoms in patients with HD over a 3-year period.

Efficacy in Clinical Trials

Results from the clinical trials highlighted significant reductions in mean Total Maximal Chorea (TMC) scores. Patients who continued from the double-blind First-HD trial (NCT01795859) showed a mean TMC score decrease of –4.5 points, while those transitioning from tetrabenazine showed a decrease of –2.1 points over eight weeks.

Flexible Administration Without Dietary Restrictions

The extended-release deutetrabenazine can be taken with or without food and is currently the only VMAT2 inhibitor with no restriction on concurrent use with CYP3A4/5 inducers or inhibitors. However, it is contraindicated for patients with specific medical conditions, including hepatic impairment and those taking certain medications.

Expert Opinions

Dell Faulkingham, senior vice president and head of Innovative Medicines at Teva, emphasized that the new approval offers a streamlined treatment regimen that aids in better managing involuntary movements. Rakesh Jain, PhD, MS, clinical professor of psychiatry at Texas Tech University, noted that this approval is crucial for patients juggling multiple chronic conditions.

Real-World Implications

This new treatment option offers real-world benefits by simplifying medication regimens, thus encouraging better adherence and improving quality of life for patients managing chronic movement disorders.

Looking Ahead

With the recent approval of the extended-release formulation, the focus now shifts to monitoring real-world efficacy and patient adherence. This could pave the way for more user-friendly treatment options for other chronic conditions.

Conclusion

The FDA approval of once-daily deutetrabenazine marks a significant advancement in the treatment of tardive dyskinesia and chorea associated with Huntington's disease, providing greater flexibility and convenience for patients.