Neurocrine wins approval of Ingrezza 'sprinkle' formulation for patients with trouble swallowing

Neurocrine Biosciences won FDA approval on Tuesday for a new formulation that may help Ingrezza go down in a more delightful way.

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Clik here to view.Eric Benevich

The oral granules are designed to be opened and sprinkled over soft foods, as opposed to the company’s currently approved capsules that are intended to be swallowed whole. Ingrezza was approved in 2017 and 2023 for tardive dyskinesia and Huntington’s chorea, respectively — two conditions that may impact patients’ ability to swallow. Neurocrine commercial chief Eric Benevich said on the company’s fourth-quarter 2023 earnings call in February that an estimated 5% to 10% of these patients have difficulty swallowing, according to an AlphaSense transcript.

Ingrezza, also known as valbenazine, generated $1.84 billion in 2023. In February, Neurocrine set its 2024 sales goal at $2.1 billion to $2.2 billion, driven mainly by new patients with tardive dyskinesia.

The drug competes with Teva’s Austedo, which won a label expansion last year as an extended-release once-daily tablet. Teva reported $1.2 billion in Austedo sales in 2023.