FDA Approves Ingrezza Sprinkle (valbenazine) for Tardive Dyskinesia and Chorea Associated with Huntington’s Disease.
The FDA has approved Ingrezza Sprinkle (valbenazine) for the treatment of adults with tardive dyskinesia and chorea associated with Huntington’s disease. This new sprinkle formulation offers an alternative administration method, allowing the capsule contents to be sprinkled over soft food or swallowed whole with water, which may improve adherence for patients with swallowing difficulties.
Ingrezza Sprinkle is a vesicular monoamine transporter 2 (VMAT2) inhibitor, a class of drugs used to reduce involuntary movements. The approval for tardive dyskinesia is based on adequate and well-controlled studies of Ingrezza, which demonstrated efficacy in patients with moderate to severe symptoms as measured by the Abnormal Involuntary Movement Scale (AIMS). For chorea associated with Huntington’s disease, the label indicates effectiveness established from studies of Ingrezza, though specific trial data for the sprinkle formulation is not separately detailed.
The clinical significance lies in providing another treatment option for these often debilitating movement disorders, with a flexible dosing schedule and specific administration instructions that cater to patient needs, including those with hepatic impairment or specific pharmacogenetic profiles.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Ingrezza and Ingrezza Sprinkle are vesicular monoamine transporter 2 (VMAT2) inhibitors.
Indicated for the treatment of adults with: tardive dyskinesia; chorea associated with Huntington’s disease.
For tardive dyskinesia: Initial dosage is 40 mg once daily. After one week, increase to the recommended dosage of 80 mg once daily. A dosage of 40 mg or 60 mg once daily may be considered depending on response and tolerability. For chorea associated with Huntington’s disease: Initial dosage is 40 mg once daily. Increase the dose in 20 mg increments every two weeks to the recommended dosage of 80 mg once daily. A dosage of 40 mg or 60 mg once daily may be considered depending on response and tolerability. Can be taken with or without food. Ingrezza Sprinkle may be opened and sprinkled over soft food (do not use milk or drinking water) or swallowed whole with water. Do not crush or chew. Do not administer via nasogastric, gastrostomy, or other enteral tubes. The recommended dosage for patients with moderate or severe hepatic impairment (Child-Pugh score 7 to 15) is 40 mg once daily. The recommended dosage for known CYP2D6 poor metabolizers is 40 mg once daily. For patients receiving strong CYP3A4 inhibitors or strong CYP2D6 inhibitors, the recommended dosage is 40 mg once daily. Concomitant use with strong CYP3A4 inducers is not recommended.
The effectiveness of Ingrezza Sprinkle for tardive dyskinesia has been established from adequate and well-controlled studies of Ingrezza. A randomized, double-blind, placebo-controlled trial of Ingrezza was conducted in patients with moderate to severe tardive dyskinesia as determined by clinical observation. Patients had underlying schizophrenia, schizoaffective disorder, or a mood disorder. The primary efficacy measure was the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score (sum of items 1 to 7, range 0 to 28), with a decrease indicating improvement. The AIMS was scored by central raters blinded to treatment. Specific efficacy results and data for chorea associated with Huntington’s disease are not detailed in the provided label text.
Not reported in label.
Not reported in label.
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