FDA Approves Austedo for Treatment of Huntington Disease-Associated Chorea
The US Food and Drug Administration has approved Austedo (deutetrabenazine) tablets for the treatment of chorea in patients with Huntington disease.
The safety and efficacy of Austedo was established in a phase III randomized, placebo-controlled trial that included 90 patients with chorea associated with Huntington disease randomly assigned to received Austedo or placebo. Austedo was found to improve Total Maximal Chorea Scores by 4.4 units over an average of 9 to 12 weeks compared with 1.9-unit improvement in participants taking placebo. One week after discontinuation of Austedo, participants' Total Maximal Chorea Scores returned to baseline.
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The most common adverse effects associated with Austedo are somnolence, diarrhea, dry mouth, fatigue, and sedation, as well as an increased risk of depression and suicidal thoughts and behaviors. The risk of suicide and depression should be considered by patients before taking Austedo.
Austedo is a contradiction for patients with untreated or inadequately treated depression, who are suicidal, have hepatic impairment, are taking monoamine oxidase inhibitors, reserpine, or tetrabenazine.
In addition, Austedo may increase the risk of akathisia, agitation and restlessness, and may cause parkinsonism in patients with Huntington disease.
—Melissa Weiss
Reference:
Teva announces FDAaApproval of AUSTEDO™ (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s Disease [press release]. Jerusalem, IL: Business Wire. April 3, 2017. http://www.businesswire.com/news/home/20170403006578/en/.