Antipsychotic Side Effect Treatment Gets FDA Approval
Valbenazine is the first drug approved for the treatment of tardive dyskinesia, an adverse effect associated with some antipsychotic medications.
The US Food and Drug Administration (FDA) has approved the first drug for the treatment of tardive dyskinesia, an adverse effect associated with the use of some antipsychotic medications characterized by involuntary movements of the jaw, lips, and tongue or extremities.1
Ingrezza™ (valbenazine) was approved without a black box warning for depression or suicide, making it an attractive option for prescribers vs up-and-coming competitors including Teva's Austedo™, which was recently approved for the treatment of Huntington's chorea and is awaiting an FDA decision for its tardive dyskinesia indication.
“Until now, one of the few options for physicians, when managing TD, was to stop, change, or lower the dose of antipsychotic medication, potentially jeopardizing patients' psychiatric stability,” Christoph U. Correll, MD, Professor of Psychiatry and Molecular Medicine at Hofstra Northwell School of Medicine, said in a press release.2 “In clinical trials, Ingrezza significantly and rapidly improved TD symptoms compared to placebo, reducing involuntary movements acutely and through 48 weeks of treatment without compromising underlying psychiatric care. These results, combined with convenient once-daily dosing, represent a tremendous breakthrough for patients suffering from TD.”
Results from the 6-week, phase 3 KINECT-3 trial (ClinicalTrials.gov Identifier: NCT02274558) showed a significant mean change in Abnormal Involuntary Movement Scale (AIMS) dyskinesia score of -3.2 in the 80 mg/d treatment group vs -0.1 in the placebo group.3
Adverse effects associated with valbenazine include sleepiness and QT prolongation. Patients with congenital long-QT syndrome or those with an abnormal heart rhythm associated with a prolonged QT interval should not take valbenazine. Patients are encouraged to not drive or operate heavy machinery or engage in dangerous activities until they know how valbenazine will affect them.
Neurocrine Biosciences will reportedly disclose the drug's price when it becomes available on May 1, 2017.
- FDA approves first drug to treat tardive dyskinesia [news release]. FDA Newsroom; April 11, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm552418.htm
- Neurocrine announces FDA approval of Ingrezza™ (valbenazine) capsules as the first and only approved treatment for adults with tardive dyskinesia (TD) [news release]. San Diego, CA: Neurocrine Biosciences newsroom; April 11, 2017. http://phoenix.corporate-ir.net/phoenix.zhtml?c=68817&p=RssLanding&cat=news&id=2261452
- Hauser RA, Factor SA, Marder SR, et al. KINECT 3: a phase 3 randomized, double-blind, placebo-controlled trial of valbenazine for tardive dyskinesia [published online March 21, 2017]. Am J Psychiatry. doi: 10.1176/appi.ajp.2017.16091037