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Swallowing Made Easy: FDA Approves Innovative Ingrezza Capsule for Swallowing Difficulties

The FDA has given the nod to Neurocrine Biosciences’ latest innovation: a sprinkle capsule version of Ingrezza (valbenazine), designed to tackle swallowing difficulties in patients dealing with uncontrollable movements caused by tardive dyskinesia and Huntington’s disease.

Unlike the traditional pill, these sprinkle capsules come in 40 mg, 60 mg, and 80 mg doses and can be easily opened and sprinkled onto soft foods. This adjustment offers a practical solution for patients who struggle to swallow whole pills, a common challenge highlighted by Neurocrine.

Neurocrine's Chief Medical Officer, Eiry Roberts, emphasized the importance of this development, saying, “We developed Ingrezza Sprinkle to make administration easier for patients who have difficulty swallowing or prefer not to take a capsule." Roberts added, "We are pleased to offer the proven efficacy of Ingrezza in reducing uncontrollable movements in a new formulation."

The FDA’s approval was based on data demonstrating that the sprinkle capsules are as effective as the original pill form. Neurocrine also provided evidence indicating similar tolerance levels for both versions.

Ingrezza works by targeting a specific transporter in cells involved in movement regulation, although the exact mechanism remains unclear. Initially approved in 2017 for tardive dyskinesia, a condition characterized by repetitive, uncontrollable movements, the drug gained another approval in 2023 for chorea in Huntington’s disease.

These approvals have made Ingrezza Neurocrine’s top-selling product. In 2023, the drug accounted for almost all of the company's revenue, bringing in $1.84 billion out of nearly $1.89 billion. For 2024, Neurocrine expects Ingrezza sales to range between $2.1 billion and $2.2 billion.

However, despite its success, Ingrezza's original pill form posed challenges for patients with swallowing difficulties. According to recent surveys, 62% of Huntington’s disease patients with chorea, along with their caregivers, reported difficulty swallowing due to involuntary movements. Similarly, 37% of tardive dyskinesia patients with moderate-to-severe involuntary movements faced issues with eating and drinking.



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