Neurocrine Biosciences has received approval from the US Food and Drug Administration (FDA) for INGREZZA® SPRINKLE (valbenazine) capsules, a novel oral granules formulation of INGREZZA® (valbenazine) capsules, designed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease. 

This approval provides an alternative administration option for individuals experiencing dysphagia or difficulty swallowing.

INGREZZA SPRINKLE simplifies dosing for patients, offering a straightforward regimen of one capsule taken once daily, mirroring the convenience of the original INGREZZA capsules. This new formulation maintains the flexibility of dosage adjustment, with three effective dosages (40 mg, 60 mg, and 80 mg) available for healthcare providers to tailor treatment based on patient response and tolerability. Like its predecessor, INGREZZA SPRINKLE allows the contents of the capsules to be easily sprinkled on soft food for oral administration.

Dr. Eiry W. Roberts, Chief Medical Officer at Neurocrine Biosciences, highlighted the significance of this development, stating, "We developed INGREZZA SPRINKLE to make administration easier for patients who have difficulty swallowing or prefer not to take a capsule. We are pleased to offer the proven efficacy of INGREZZA in reducing uncontrollable movements in a new formulation."

The approval of INGREZZA SPRINKLE follows FDA review of chemistry, manufacturing, and controls information, along with data demonstrating the bioequivalence and tolerability of the new formulation compared to the original INGREZZA capsules.

The introduction of INGREZZA SPRINKLE addresses a substantial need for patients with tardive dyskinesia and chorea associated with Huntington's disease, particularly those facing challenges with swallowing pills. Surveys conducted among patients and caregivers underscore the difficulties encountered, with a significant proportion reporting issues with swallowing due to involuntary movements.