Neurocrine announces publication of data from Phase 3 KINECT-4 study of INGREZZA

Neurocrine Biosciences announced the publication of data from a post hoc analysis of the Phase 3 KINECT-4 study of INGREZZA capsules in the Journal of Clinical Psychopharmacology. The analysis assessed long-term outcomes relevant to the real-world management of tardive dyskinesia and demonstrated that nearly all study participants met the threshold for clinically meaningful improvements in TD symptom severity by Week 48. Key highlights include: At Week 4, 55% of participants experienced clinically meaningful improvement in TD symptom severity on the lowest starting dose (40 mg). A clinically meaningful improvement was defined as a reduction of at least 2 points in the Abnormal Involuntary Movement Scale total score used to assess the severity of involuntary movements in different body regions. Ninety-five percent of participants reached this threshold as soon as Week 24, with 97% achieving it by Week 48. TD improvement was sustained throughout treatment, with an AIMS mean total score reduction from baseline to Week 48 of 10.5. Eighty-six percent of participants met the response threshold of at least 50% AIMS improvement, and 52% met the higher threshold of at least 70% AIMS improvement at Week 48. More than 88% of patients and healthcare professionals rated participants’ symptoms as “much improved” or “very much improved” at Week 48, as measured by the Patient Global Impression of Change and Clinical Global Impression of Change-TD, respectively. Overall, INGREZZA was generally well tolerated. The most common treatment emergent adverse events reported from Weeks 4 to 48 included urinary tract infection (8.5%) and headache (5.2%).