FDA accepts NDA for Ingrezza oral granules sprinkle formulation

The Ingrezza oral granules capsules (40 mg, 60 mg and 80 mg) are intended to be opened for sprinkling on soft foods prior to administration. The NDA filing included chemistry, manufacturing, and controls (CMC) information and data demonstrating the bioequivalence and tolerability of the Ingrezza oral granule sprinkle capsules compared to the currently approved Ingrezza capsules.

"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, M.D., 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."

Ingrezza is currently available as the only one-capsule, once-daily treatment option with no complex titration for adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease. It is the only selective vesicular monoamine transporter 2 (VMAT2) inhibitor that offers three effective dosages (40 mg, 60 mg and 80 mg) that can be adjusted by the healthcare provider based on patient response and tolerability.