The FDA has approved Teva’s Austedo (deutetrabenazine) tablets, previously referred to as SD-809, for chorea associated with Huntington’s disease (HD). Austedo is the first deuterated product approved by the FDA and the second product approved for HD.
The approval is based on a phase 3 randomized, placebo-controlled clinical trial. The study included 90 ambulatory patients with chorea associated with HD. Treatment duration was 12 weeks, and a statement from Teva noted that total maximal chorea scores for patients who received Austedo improved by approximately 4.4 units from baseline to the maintenance period, compared to approximately 1.9 units in the placebo group. The treatment effect of -2.5 was statistically significant, (P
< .0001), according to the statement.
Austedo is contraindicated and includes a boxed warning in patients who are suicidal or patients with untreated or inadequately treated depression, as the drug can increase the risk of depression and suicidal thoughts and behaviors in patients with HD. It is also contraindicated in patients with hepatic impairment, patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy, patients taking reserpine or within 20 days of discontinuing reserpine, and patients taking tetrabenazine (Xenazine).
Adverse effects include possible worsening in mood, cognition, rigidity, and functional capacity. Austedo may also increase the risk of akathisia, agitation, and restlessness, and can cause parkinsonism in patients with HD.
Teva announces FDA approval of Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s Disease [news release]. Teva’s website. http://www.tevapharm.com/news/teva_announces_fda_approval_of_austedo_deutetrabenazine_tablets_for_the_treatment_of_chorea_associated_with_huntington_s_disease_04_17.aspx
. Accessed Apr. 4, 2017.