FDA Approves Neurocrine's 'Sprinkle' Ingrezza for Huntington’s Disease

The FDA has recently approved a new sprinkle capsule formulation of Neurocrine Biosciences' Ingrezza (valbenazine) for the treatment of tardive dyskinesia and chorea in Huntington’s disease. This new version offers the same doses as the original oral capsule—40 mg, 60 mg, and 80 mg—but can be sprinkled on soft foods, providing an easier administration method for those who have trouble swallowing capsules.

Neurocrine's Chief Medical Officer, Eiry Roberts, emphasized that this new formulation aims to assist patients who find it difficult to swallow or who prefer not to take capsules. According to Roberts, the sprinkle formulation maintains the proven efficacy of Ingrezza in reducing involuntary movements.

The approval for this new formulation is based on extensive chemistry, manufacturing, and controls data, which confirmed that the sprinkle version is bioequivalent to the original capsule. Additionally, tolerability profiles for both formulations were found to be similar.

Ingrezza is a small molecule that selectively and reversibly inhibits the vesicular monoamine transporter 2. This transporter plays a role in the movement of monoamines from the cell’s cytoplasm into synaptic vesicles, where they are either stored or prepared for release. Although the exact mechanism of Ingrezza is not fully understood, it has shown effectiveness in clinical use.

First approved in April 2017 for tardive dyskinesia, Ingrezza addresses a condition marked by repetitive, uncontrollable movements of the trunk, limbs, and face, often resulting from antipsychotic treatments. In August 2023, Ingrezza received another approval for treating chorea in Huntington’s disease.

With these indications, Ingrezza has become Neurocrine's leading product. In 2023, it generated $1.84 billion in revenue, significantly contributing to the company's total earnings of nearly $1.89 billion. For 2024, Neurocrine anticipates that Ingrezza will bring in between $2.1 billion and $2.2 billion.

Despite its commercial success, the original capsule formulation of Ingrezza posed challenges for some patients. According to Neurocrine's recent announcement, a survey involving Huntington’s disease patients with chorea and their caregivers revealed that 62% had difficulty swallowing due to involuntary movements. Similarly, a survey of tardive dyskinesia patients with moderate-to-severe involuntary movements found that 37% experienced problems with eating and drinking due to their symptoms.

These findings highlight the importance of the new sprinkle formulation, which aims to improve the quality of life for patients struggling with these conditions. The new administration method could make a significant difference for those who have faced challenges with the original capsule form.

In summary, the FDA's approval of the sprinkle capsule formulation of Ingrezza marks a significant step forward in providing more accessible treatment options for patients with tardive dyskinesia and chorea in Huntington’s disease. This new formulation retains the efficacy of the original while simplifying the administration process for those with swallowing difficulties.