FDA accepts new drug application for sprinkle form of Ingrezza capsules

The FDA has accepted a new drug application from Neurocrine Biosciences Inc. for its novel granule formulation of oral Ingrezza capsules, for those with tardive dyskinesia or chorea associated with Huntington’s disease.

According to a press release from Neurocrine, the NDA filing included chemistry, manufacturing and controls information, as well as data demonstrating the bioequivalence and tolerability of the oral granule formulation compared to currently approved once-daily capsules.

The new Ingrezza (valbenazine) formulation, at doses of 40 mg, 60 mg and 80 mg, is intended to be opened for sprinkling on soft foods prior to administration, per the release.

“Patients with tardive dyskinesia or chorea associated with Huntington's disease can experience dysphagia that can impact their ability to swallow capsules,” Eiry W. Roberts, MD, Neurocrine Biosciences chief medical officer, said in the release. “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.”

The FDA has set a Prescription Drug User Fee Act target action date of April 30, 2024.