First Exposure to Deutetrabenazine Well-Tolerated Across Patient Populations

Analysis of safety data for deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the US Food and Drug Administration for tardive dyskinesia (TD) and chorea associated with Huntington’s disease, suggests the drug is generally safe and well-tolerated in both patient populations during initial exposure. Researchers reported the findings in a poster presentation at Psych Congress 2021 in San Antonio, Texas.

“In general, serious AEs [adverse events], AEs that result in dose reduction, suspension, and discontinuation, were low for both indications,” said presenter Maria Chen, MD, PhD, associate director of clinical development, Teva Pharmaceuticals, West Chester, Pennsylvania.

The poster summarized safety data for deutetrabenazine from a pair of 12-week trials and the first 15 weeks of an open-label extension study in patients with TD as well as a single 12-week trial and the first 15 weeks of an open-label extension study in patients with Huntington’s disease chorea.

During her presentation, Dr Chen pointed out that dopamine-receptor antagonists were used by the majority of study participants with TD but were not permitted for participants with Huntington’s disease chorea.

Related: Tardive Dyskinesia: Medication Management, Your Questions Answered

In patients with TD, rates of any adverse events were between 44.4% and 59.5% with deutetrabenazine compared with 53.8% with placebo. Specifically, rates of serious adverse events were between 2.8% and 8.3% with deutetrabenazine and 6.9% with placebo; rates of treatment-related adverse events were between 15.3% and 38.1% with deutetrabenazine and 30.8% with placebo; rates of adverse events leading to withdrawal were between 2.8% and 5.6% with deutetrabenazine and 3.1% with placebo; and rates of adverse events leading to dose reduction were between 0% and 8.3% with deutetrabenazine and 2.3% with placebo.

In patients with Huntington’s disease chorea, rates of any adverse event were 64.3% with deutetrabenazine and 60% with placebo; serious adverse events, 2.4% with deutetrabenazine and 2.2% with placebo; treatment-related adverse events, 38.1% with deutetrabenazine and 26.7% with placebo; adverse events leading to withdrawal, 1.2% with deutetrabenazine and 2.2% with placebo; and adverse events leading to dose reduction, 7.1% with deutetrabenazine and 6.7% with placebo.

“Overall, we did not find any surprises in the adverse event profile,” Dr Chen said. “Of note, it’s important to realize that this analysis is looking at the first-time exposure across our clinical studies for the first 12 to 15 weeks in our clinical trials. So this is not looking at long-term exposures.”

Teva Pharmaceutical Industries sponsored the study presented in the poster.

Reference

Anderson KE, Fernandez HH, Frank S, et al. Incidence of adverse events associated with deutetrabenazine for the treatment of tardive dyskinesia and chorea associated with Huntington’s disease. Poster presented at Psych Congress; October 29-November 1, 2021; San Antonio, Texas.