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Neurocrine Biosciences have announced the U.S. FDA has approved INGREZZA SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease. INGREZZA SPRINKLE provides an alternative administration option for those who experience dysphagia or have difficulty swallowing.
"We developed INGREZZA SPRINKLE to make administration easier for patients who have difficulty swallowing or prefer not to take a capsule," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "We are pleased to offer the proven efficacy of INGREZZA in reducing uncontrollable movements in a new formulation."
Like the original formulation of INGREZZA capsules, INGREZZA SPRINKLE offers simple dosing that's always one capsule, once daily with no complex titration. INGREZZA 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. INGREZZA SPRINKLE offers the same dosage strengths, and the contents of the capsules can be easily sprinkled on soft food for oral administration.
The U.S. FDA approval was based on chemistry, manufacturing, and controls information and data demonstrating the bioequivalence and tolerability of INGREZZA SPRINKLE compared to INGREZZA capsules.