Neurocrine's INGREZZA® SPRINKLE (valbenazine) Capsules Approved by FDA

Neurocrine Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new formulation of INGREZZA® (valbenazine) capsules, known as INGREZZA® SPRINKLE. This new oral granules formulation caters to adults with tardive dyskinesia and chorea associated with Huntington's disease who may have difficulty swallowing traditional capsules.

The innovative formulation of INGREZZA SPRINKLE allows the contents of the capsules to be sprinkled on soft food for easier ingestion, providing a convenient alternative for those experiencing dysphagia. Like the original INGREZZA capsules, the SPRINKLE version offers simple dosing with three available dosages (40 mg, 60 mg, and 80 mg), ensuring flexibility based on patient needs and tolerability.

Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences, emphasized the value of this new formulation in easing the medication process for those with swallowing difficulties. INGREZZA SPRINKLE aims to maintain the proven efficacy of INGREZZA in reducing uncontrollable movements associated with tardive dyskinesia and Huntington's disease-related chorea.

Surveys indicate that many individuals with chorea associated with Huntington's disease and tardive dyskinesia face challenges in swallowing due to their involuntary movements. The FDA's approval of INGREZZA SPRINKLE is based on comprehensive data illustrating its bioequivalence and tolerability compared to the original INGREZZA capsules.

Tardive dyskinesia is characterized by involuntary, repetitive movements, often resulting from long-term use of certain mental health medications. These medications, typically antipsychotics, affect dopamine receptors in the brain, potentially leading to irregular dopamine signaling and subsequent movement disorders. Tardive dyskinesia affects about 600,000 people in the U.S. and can be severe and persistent.

Huntington's disease, a hereditary neurodegenerative disorder, manifests with motor, cognitive, and psychiatric symptoms, usually appearing between the ages of 30 and 50. Chorea, a common symptom of Huntington's disease, involves erratic and unpredictable movements that can interfere with daily activities. Huntington's disease affects approximately 41,000 adults in the U.S., with more than 200,000 at risk of inheriting the condition.

INGREZZA, developed by Neurocrine Biosciences, is the only selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the FDA for treating tardive dyskinesia and chorea associated with Huntington's disease. It works by inhibiting VMAT2, which reduces dopamine release in the brain, potentially minimizing uncontrollable movements.

Although the exact mechanism by which INGREZZA treats these conditions is not fully understood, it can be taken as a once-daily capsule alongside most psychiatric medications. INGREZZA is available in dosages of 40 mg, 60 mg, and 80 mg.

Patients should be aware of important safety information. VMAT2 inhibitors like INGREZZA can cause serious side effects, including depression and suicidal thoughts, particularly in those with Huntington's disease. Allergic reactions, sleepiness, heart rhythm problems, and neuroleptic malignant syndrome are also potential risks. Patients with liver or heart problems, pregnant or breastfeeding women, and those on certain medications should consult their healthcare provider before taking INGREZZA.

Overall, the approval of INGREZZA SPRINKLE is a significant advancement for patients with movement disorders, offering a more accessible and effective treatment option.