FDA to Review New Formulation of Ingrezza for Tardive Dyskinesia, Huntington Disease Chorea

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for valbenazine oral granules, a new sprinkle formulation for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington disease.

Valbenazine, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is currently available as capsules for oral administration under the brand name Ingrezza. The new sprinkle formulation is intended to be opened for sprinkling on soft foods prior to administration.

The NDA is supported by chemistry, manufacturing, and controls information and data showing the bioequivalence and tolerability of the valbenazine oral granule sprinkle capsules compared with the currently approved Ingrezza capsules.

A Prescription Drug User Fee Act target date of April 30, 2024 has been set for this application.

“Patients with tardive dyskinesia or chorea associated with Huntington’s disease can experience dysphagia that can impact their ability to swallow capsules,” said Eiry W. Roberts, MD, Chief Medical Officer at Neurocrine Biosciences. “We developed this potential new formulation of Ingrezza as an alternative administration option for those patients who have difficulty swallowing or simply prefer not to take whole capsules.”

This article originally appeared on MPR