#United States #San Diego #Neurocrine Biosciences #INGREZZA #Tardive Dyskinesia

Neurocrine Biosciences Reports Promising Data from KINECT-PRO Study

Neurocrine Biosciences, a prominent player in the field of biopharmaceuticals, announced groundbreaking results from their KINECT-PRO Phase 4 study, focusing on their medication INGREZZA (valbenazine) and its impact on patients suffering from tardive dyskinesia (TD). This condition is characterized by uncontrollable and repetitive movements that can severely affect quality of life. The KINECT-PRO study aims to assess not just the clinical efficacy of INGRZZA but also the patient experience related to the disorder.

Key Findings of the Study

The KINECT-PRO study revealed impressive and clinically significant outcomes, with patients reporting meaningful improvements in their functionality and overall quality of life. Enrollment included 59 patients, each of whom received INGREZZA for a period of up to 24 weeks. Importantly, the study considered various severities of TD as well as underlying psychiatric conditions, such as schizophrenia and bipolar disorder.

Dr. Eiry W. Roberts, Chief Medical Officer at Neurocrine, emphasized, "Tardive dyskinesia can critically impede many aspects of life, including daily tasks, workplace attendance, and social interactions. The findings from KINECT-PRO showcase substantial reductions in TD symptoms and improvements in overall well-being following treatment with INGREZZA."

Methodology

The KINECT-PRO study’s primary goal was to investigate changes in patient-reported impacts of TD, as measured by various validated scales, including the Tardive Dyskinesia Impact Scale (TDIS) and the Sheehan Disability Scale (SDS). Assessments were conducted at Weeks 4, 8, 16, and 24, allowing researchers to capture comprehensive data regarding the drug's impact over time. Secondary assessments involved evaluations of TD severity using the Abnormal Involuntary Movement Scale (AIMS) and other subjective scales.

Outcomes

Results indicated a substantial and sustained improvement across patient-reported outcome measures, with notable enhancements starting as early as Week 4 of treatment at the lowest INGREZZA dosage of 40 mg. The AIMS scores demonstrated a consistent reduction in involuntary movements, reinforcing the efficacy of INGREZZA for both mild and moderate/severe TD cases.

The safety profile observed in the study was consistent with existing knowledge regarding INGREZZA, with no unexpected adverse effects reported.

The Importance of the Tardive Dyskinesia Impact Scale (TDIS)

A standout feature of the KINECT-PRO study was the incorporation of the TDIS, a newly developed scale that evaluates the socio-emotional and physical impacts of TD from the patients' perspectives. This instrument is regarded as a critical step forward in understanding how patients manage the burden of this condition on their daily lives and emotional well-being.

Insights on Tardive Dyskinesia and INGREZZA

Tardive dyskinesia is often linked with long-term use of antipsychotic medications, which can lead to abnormal dopamine signaling in the brain. Though TD can have a significant impact on well-being, INGREZZA has emerged as a judicious option that directly targets the root of the issue by inhibiting excessive dopamine release.

Unique Formulation and Availability

INGREZZA is recognized for its unique formulation, available in flexible dosages of 40 mg, 60 mg, and 80 mg capsules, facilitating easy integration into therapy regimens. For patients experiencing difficulty swallowing, the alternative INGREZZA SPRINKLE option is available.

Future Directions

As the findings from KINECT-PRO are set to be presented at future scientific conferences, this marks an essential step for Neurocrine Biosciences in cementing the role of INGREZZA in the treatment landscape of tardive dyskinesia. These results not only highlight the therapeutic potential of INGREZZA but also underscore Neurocrine's commitment to improving patient lives affected by largely overlooked neurological disorders. The company continues to innovate and address significant medical needs in this challenging area.

In conclusion, the KINECT-PRO study results herald a promising future for patients with TD, offering new hope for management strategies that take into account both the clinical and personal repercussions of the disorder.