This week Neurocrine Biosciences announced the results of its KINECT®-4 Phase 3 study of INGREZZA® capsules. Results of the trial were published in the Journal of Clinical Psychopharmacology.
A long-term analysis found that almost all the participants in the study achieved the goal of meaningful improvement by week 48.
About Tardive Dyskinesia (TD) KINECT-4 Study
The Chief Medical Officer at Neurocrine Biosciences, Dr. Eiry Roberts, explained to PRNewswire that tardive dyskinesia is considered a debilitating condition which requires continuous and timely treatment to improve symptoms.
Dr. Eiry said that analyses, both current and prior, demonstrate the efficacy of an INGREZZA-4 capsule taken once daily. The new study involved 103 people who had completed the KINECT-4 Phase 3 study and who had been treated with INCREZZA for 48 weeks. The KINECT-4 study was developed to be comparable to the average clinical practice thus giving insight into INGREZZA’s real world TD management. FDA researchers define real world data and evidence as being derived from many sources other than typical clinical settings.
Highlights of the trial include:
- Beginning at 40mg (the lowest dose) to 80mg at the fourth week, 55% of study participants reported a two-point reduction. That is considered clinically meaningful according to the AIMS scale.
- By week 48, 97% of study participants reportedly reached the threshold.
- Positive results continued with the average AIMS score reduction by week 48 reported to be 10.5.
- And finally, over 88% of healthcare workers and patients reported patients’ symptoms to be “much improved.”
- During weeks four through 48, INGREZZA was reported to be well tolerated. Its most common adverse events were headaches and infections in the urinary tract.
About Tardive Dyskinesia
Tardive dyskinesia presents abnormal, uncontrollable, and repetitive facial movements in the torso and other parts of the body. The disorder may be caused by taking medicines for mental health or gastrointestinal diseases. There are approximately 600,000 people in the U.S. affected by TD.
Although the FDA has approved three VMAT2 inhibitors, INGREZZA stands alone as the once daily, one capsule VMAT2 inhibitor that is FDA approved to treat adults with TD and also chorea related to Huntington’s disease.
Important Safety Information
It has not yet been established if INGREZZA is safe for children. INGREZZA may cause severe side effects to patients with Huntington’s disease. These patients should notify their healthcare team before taking the product.
