Neurocrine Validates Patient-Reported Outcome Scale for Tardive Dyskinesia Treatment

Event summary

  • Neurocrine Biosciences published research in The Journal of Clinical Psychiatry defining a clinically meaningful improvement threshold of four points on the Tardive Dyskinesia Impact Scale (TDIS).
  • The TDIS, developed in partnership with neurology and psychiatry thought leaders, is the first psychometrically validated patient-reported outcome measure for tardive dyskinesia (TD).
  • The publication supports previously reported results from the KINECT-PRO™ Phase 4 study, demonstrating patient-reported improvements with INGREZZA® (valbenazine) across physical, social, and emotional functioning.
  • The KINECT-PRO™ study involved 40 mg of INGREZZA once-daily for the first four weeks, followed by flexible dosing of 40 mg, 60 mg or 80 mg once-daily based on individual treatment needs.

The big picture

Neurocrine's validation of the TDIS represents a shift towards patient-centric drug development in the treatment of TD, a condition affecting an estimated 800,000 adults in the U.S. This focus on patient-reported outcomes is increasingly important for demonstrating the real-world value of therapies and securing favorable reimbursement. The TDIS's unique validation and adoption could create a barrier to entry for competitors seeking to address this underserved market.

What we're watching

Adoption Rate
The extent to which clinicians and researchers adopt the TDIS as a standard measure for assessing TD treatment response will influence Neurocrine's ability to demonstrate value and potentially impact reimbursement decisions.
Competitive Landscape
Competitors may attempt to develop alternative patient-reported outcome measures, potentially challenging the TDIS's established position and Neurocrine's market advantage.
Clinical Utility
Further research is needed to determine how the TDIS can be best integrated into clinical practice to optimize patient care and inform treatment decisions beyond the KINECT program.

Related topics

Pharmaceuticals Drug Development Clinical Trial