Neurocrine Biosciences Reveals Groundbreaking INGREZZA® (valbenazine) Data at Annual Meeting
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) has announced the presentation of pioneering head-to-head data comparing the vesicular monoamine transporter 2 (VMAT2) target occupancy of INGREZZA® (valbenazine) capsules against AUSTEDO XR (deutetrabenazine). This study reveals that INGREZZA exhibits a significantly higher VMAT2 occupancy, indicating greater potency, an essential consideration for treatments addressing movement disorders such as tardive dyskinesia (TD) and chorea associated with Huntington's disease. The findings were shared at the American College of Neuropsychopharmacology's 64th Annual Meeting held from January 12-15 in the Bahamas.
Key Findings on VMAT2 Occupancy
The study assessed VMAT2 occupancy, a critical metric for understanding drug efficacy in hyperkinetic movement disorders. Higher VMAT2 occupancy suggests better engagement of the target, helping to regulate dopamine transmission linked to involuntary movements. Specifically, INGREZZA demonstrated:
- Approximately two-fold higher VMAT2 target occupancy in comparison to AUSTEDO XR at therapeutic doses.
- A mean VMAT2 occupancy of 76.5% for INGREZZA versus 38.3% for AUSTEDO XR in the primary analysis.
Clinical Expert Commentary
Dr. Sanjay Keswani, Chief Medical Officer at Neurocrine Biosciences, remarked, "This head-to-head assessment positions INGREZZA as a superior option, with its approximately two-fold higher target occupancy compared with AUSTEDO XR. The enhanced VMAT2 occupancy underscores the differences in pharmacologic profiles and the potentially greater clinical efficacy of INGREZZA."
Study Methodology
The clinical study employed positron emission tomography (PET) imaging to analyze VMAT2 occupancy after administering single doses of either INGREZZA (40 mg or 80 mg) or AUSTEDO XR (24 mg or 48 mg) to eight participants, each undergoing four PET visits. The data pointed to a consistent pattern:
- INGREZZA at 40 mg produced an estimated 83% steady-state VMAT2 occupancy.
- INGREZZA at 80 mg showed a remarkable 92% VMAT2 occupancy.
- AUSTEDO XR, conversely, had levels of 54% at 24 mg and 70% at 48 mg doses.
Understanding Tardive Dyskinesia and Chorea
Tardive dyskinesia is characterized by abnormal involuntary movements resulting from long-term use of certain antipsychotic medications, potentially affecting over 800,000 adults in the U.S. Meanwhile, Huntington's disease impacts approximately 41,000 adults, leading to severe motor, cognitive, and psychiatric complications.
About INGREZZA®
INGREZZA is a first-in-class, selective VMAT2 inhibitor approved by the U.S. Food and Drug Administration, specifically for treating adults with tardive dyskinesia and chorea associated with Huntington's disease. Distinctly, INGREZZA offers a therapeutic dose from day one without the need for titration, making it a viable option for patients seeking stable treatment options.
Concluding Notes
Overall, the comparative data presented regarding INGREZZA's VMAT2 occupancy reinforces its potential as a leading treatment in managing involuntary movement disorders. The comprehensive insights gained from this study contribute to the evolving landscape of pharmacological solutions offered by Neurocrine Biosciences under the symbol NBIX.