Neurocrine Biosciences Publishes Phase 3 Analysis Showing Long-Term INGREZZA® Benefits for Tardive Dyskinesia

Neurocrine Biosciences, Inc., based in San Diego, has unveiled findings from a post hoc analysis of the Phase 3 KINECT-4 study on INGREZZA (valbenazine) capsules, published in the Journal of Clinical Psychopharmacology. This analysis focused on the long-term management of tardive dyskinesia (TD), a chronic and often debilitating movement disorder. The study showed that nearly all participants achieved significant improvements in TD symptoms by the 48th week of treatment.

According to Dr. Eiry W. Roberts, Chief Medical Officer at Neurocrine Biosciences, "TD requires ongoing treatment to sustainably improve symptoms over time." The KINECT-4 study, with its open-label design, aimed to reflect real-world clinical practice in managing TD with INGREZZA. The study involved 103 participants who completed 48 weeks of treatment, providing valuable insights into the long-term efficacy and tolerability of the drug.

Key findings from the study include:
- By the fourth week, 55% of participants showed a clinically meaningful improvement in TD symptom severity at the initial 40 mg dose. This improvement was defined as at least a 2-point reduction in the Abnormal Involuntary Movement Scale (AIMS) total score.
- By the 24th week, 95% of participants had reached this improvement threshold, with 97% achieving it by the 48th week. The mean total score reduction from baseline to week 48 was 10.5.
- At week 48, 86% of participants met the response threshold of at least 50% AIMS improvement, and 52% met the higher threshold of at least 70% improvement.
- Over 88% of patients and healthcare professionals rated the participants' symptoms as "much improved" or "very much improved" at week 48, based on the Patient Global Impression of Change and Clinical Global Impression of Change-TD, respectively.

INGREZZA was generally well tolerated throughout the study period. The most common adverse events from weeks 4 to 48 were urinary tract infection (8.5%) and headache (5.2%).

The KINECT-4 Phase 3 study included 163 participants with moderate to severe TD, accompanied by underlying conditions such as schizophrenia, schizoaffective disorder, or mood disorders. All participants began treatment with a 40 mg/day dose, which could be increased to 80 mg/day at week 4 based on effectiveness and tolerability. Those who could not tolerate the higher dose were allowed to revert to the 40 mg dose. Participants showed significant improvements in their TD symptoms over the 48-week treatment period, as indicated by a mean change from baseline in AIMS total score with INGREZZA 40 mg/day (-10.2) or 80 mg/day (-11.0).

Tardive dyskinesia is characterized by involuntary, repetitive movements of various body parts, often resulting from long-term use of antipsychotic medications. TD is estimated to affect approximately 600,000 people in the United States. INGREZZA, the first and only once-daily selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration (FDA) for TD and chorea associated with Huntington's disease, aims to mitigate these symptoms by reducing irregular dopamine signaling in the brain.

INGREZZA capsules are available in 40 mg, 60 mg, and 80 mg strengths, and can be taken alongside most psychiatric medications. However, patients with Huntington’s disease should be cautious, as INGREZZA can cause serious side effects, including depression and suicidal thoughts. Common side effects include sleepiness and tiredness.

Neurocrine Biosciences remains committed to developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders, with a pipeline of multiple compounds in various phases of clinical development.

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