FDA Approves Ingrezza Sprinkle Formulation for Tardive Dyskinesia or Chorea Associated with Huntington Disease

The Food and Drug Administration (FDA) has approved a new sprinkle formulation of Ingrezza (valbenazine; Neurocrine Biosciences, San Diego, CA) for patients with tardive dyskinesia (TD) or chorea associated with Huntington disease (HD). The oral granule capsules (available in 40 mg, 60 mg, and 80 mg) are intended to be opened and sprinkled on soft foods prior to administration, providing a more convenient option for patients who have difficulty swallowing.  The new formulation was approved based on data demonstrating the bioequivalence and tolerability of the sprinkles compared with previously approved capsules.

In the phase 3 KINECT-HD study, Ingrezza treatment resulted in improved chorea as early as 2 weeks, with consistently greater improvement compared to placebo. The study also met its secondary endpoints on clinical and patient global impression.

Ingrezza is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, which functions by augmenting neurotransmitter degradation, resulting in presynaptic neurotransmitter depletion, specifically of dopamine. Ingrezza’s prescribing information contains a Boxed Warning for risk of depression and suicidal ideation/actions.

"We developed Ingrezza Sprinkle to make administration easier for patients who have difficulty swallowing or prefer not to take a capsule," said Eiry W. Roberts, MD, Chief Medical Officer at Neurocrine Biosciences. "We are pleased to offer the proven efficacy of Ingrezza in reducing uncontrollable movements in a new formulation."