Neurocrine Biosciences Presents Data on Improvements Over Time with Long-Term Use of INGREZZA Capsules in Older and Elderly Patients

Neurocrine (NASDAQ:NBIX) Biosciences, Inc. (Nasdaq: NBIX) today announced it will present data analyzing the long-term outcomes of treating tardive dyskinesia (TD) with INGREZZA® (valbenazine) capsules in older (≥55 years) and elderly (≥65 years) patients from two studies (KINECT™ 3-extension and KINECT™ 4). These data (Poster #NR-36, Improvements Over Time with Long-Term Valbenazine in Older and Elderly Patients with Tardive Dyskinesia) are being presented at the American Association for Geriatric Psychiatry (AAGP) 2023 Annual Meeting from March 3­­­–6 in New Orleans.

The data demonstrated that long-term treatment with once-daily INGREZZA led to clinically meaningful reductions of TD symptoms in both older patients with TD and elderly patients. At 48 weeks of INGREZZA treatment, >80 percent of participants in the ≥65 years age group met the >50 percent improvement in the Abnormal Involuntary Movement Scale (AIMS) response threshold. Analyses included the following:

• Mean change from baseline in AIMS total score
• Percentage of patients meeting AIMS response thresholds, including ≥50 percent improvement from baseline (protocol-defined response) and ≥70 percent improvement from baseline (stringent response)
• Global response thresholds, including Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) and Patient Global Impression of Change (PGIC) defined as "much improved" or "very much improved" (score ≤2)

Similar results were found in the ≥55 years age group. Mean changes from baseline to week 48 in psychiatric symptom scale scores were minimal, indicating maintenance of psychiatric stability in both age groups.

"Older and elderly adults treated with dopamine receptor blocking agents, including antipsychotics, have an increased risk for developing TD," said Eiry W. Roberts, MD, Chief Medical Officer at Neurocrine Biosciences. "The results of this post-hoc analysis regarding long-term use of INGREZZA in this vulnerable patient population can be used to better inform treatment decisions for those experiencing TD."

The Diagnostic Statistical Manual of Mental Disorders (DSM-5-TR) notes that middle-aged and elderly individuals have an increased risk for TD.

Key findings from the data analyses include:

• In both age groups, mean improvements in AIMS total score increased over time. At week 8 (first pooled post-baseline visit) and week 48 (end of treatment), mean score changes from baseline in the ≥65 years age group were -4.5 and -8.8, respectively
• The percentage of participants in this age group who met response thresholds were as follows: AIMS ≥50 percent improvement (40.0 percent [20/50] and 82.1 percent [23/28] for weeks 8 and 48, respectively); CGI-TD ≤2 (33.3 percent [17/51] and 92.9 percent [26/28]); PGIC ≤2 (43.1 percent [22/51]; and 85.7 percent [24/28]). Similar results were found in participants aged ≥55 years
• Safety analyses indicated similar incidences between age groups for any treatment-emergent adverse event (TEAE) (76.8 percent and 72.7 percent for ≥55 years [n=190] and ≥65 years [n=55], respectively), serious TEAEs (20.5 percent and 18.2 percent); and the most common TEAEs (headache 10.0 percent and somnolence/urinary tract infection 10.9 percent)
• Psychiatric symptom scale scores were minimal, indicating maintenance of psychiatric stability in both age groups

Additional presentation includes:

• Use of Anticholinergics for Drug-Induced Movement Disorders with Implications for Elderly Patients (Poster #NR-35)

The full abstracts being presented by Neurocrine Biosciences at AAGP 2023 are available on the meeting website and can be accessed by registering.