Ingrezza Sprinkle Capsules Received FDA Approval for Tardive Dyskinesia in Adults

wladimir1804/Adobestock

The US Food and Drug Administration approved Ingrezza Sprinkle (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). Ingrezza Sprinkle is a new oral granules formulation of the medication, which is currently approved for the treatment of TD.¹ The new formulation was also approved for the treatment of chorea associated with Huntington's disease in adults.

"We developed Ingrezza Sprinkle to make administration easier for patients who have difficulty swallowing or prefer not to take a capsule," Eiry W. Roberts, MD, Chief Medical Officer at Neurocrine Biosciences, said in a press statement. "We are pleased to offer the proven efficacy of Ingrezza in reducing uncontrollable movements in a new formulation."

The FDA based its approval on data showing bioequivalence and tolerability of Ingrezza Sprinkle as compared with to Ingrezza capsules. According to the press release, more than one-third of patients with TD who experience moderate-to-severe involuntary movement symptoms reported that the movements affected their ability to eat and drink.¹

Ingrezza was the first drug approved to treat TD in 2017.² At the time it was granted Fast Track, Priority Review, and Breakthrough Therapy designations. Mitchell Mathis, MD, the director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research at the time, said, "Tardive dyskinesia can be disabling and can further stigmatize patients with mental illness."²

Although the specific mechanism of action is not completely understood, Ingrezza selectively inhibits vesicular monoamine transporter (VMAT)2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors.¹ The capsules are available in 3 doses: 40 mg, 60 mg and 80 mg. The new formulation can be sprinkled onto soft foods, thereby making it easier for patients who have difficulty swallowing or experience dysphagia.

References

1. Neurocrine Biosciences Announces U.S. FDA Approval of INGREZZA® SPRINKLE (valbenazine) Capsules. Press release. PR Newswire; Apr 30, 2024. Accessed April 30, 2024. https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-us-fda-approval-of-ingrezza-sprinkle-valbenazine-capsules-302132283.html

2. FDA approves first drug to treat tardive dyskinesia. Press release; April 11, 2017. Accessed April 30, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-tardive-dyskinesia