FDA approves Ingrezza sprinkle capsules for tardive dyskinesia, Huntington’s chorea
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The FDA has approved Ingrezza sprinkle capsules to treat adults with Huntington’s disease chorea or tardive dyskinesia, according to a press release from the manufacturer.
Approval of the selective vesicular monoamine transporter 2 inhibitor was based on “chemistry, manufacturing and controls information,” as well as data demonstrating the bioequivalence and tolerability of the sprinkle formulation compared to capsules, Neurocrine Biosciences said in the release.
The novel sprinkle formulation aims to provide an alternative option for individuals with HD who experience dysphagia or difficulty swallowing. Sprinkle capsules of Ingrezza (valbenazine) will be available in the same dosage strengths (40 mg, 60 mg, 80 mg) as oral capsules, with the contents of the sprinkle formulation able to be spread on soft food for oral administration.
The FDA had previously approved Ingrezza oral capsules in August 2023, with subsequent acceptance of a new drug application for the sprinkle formulation in September 2023.
"We are pleased to offer the proven efficacy of Ingrezza in reducing uncontrollable movements in a new formulation,” Eiry W. Roberts, MD, chief medical officer at Neurocrine Biosciences, said in the release.
Editor’s note: This story was updated May 2, 2024, to clarify the FDA indication. Healio regrets the error.