WASHINGTON (dpa-AFX) - Neurocrine Biosciences Inc. (NBIX) announced publication of a post-hoc analysis from two 48-week studies, the KINECT 3 extension and KINECT 4, demonstrating the long-term safety profile and robust efficacy of INGREZZA (valbenazine) capsules in adults aged 65 years and older with tardive dyskinesia in The Journal of Clinical Psychiatry.
The data from the post-hoc analysis show substantial and sustained improvements in tardive dyskinesia symptoms in older adults, with no new treatment-emergent adverse events of clinical concern found when compared with younger adults (less than 65 years).
Individuals aged 60 years and older may develop tardive dyskinesia after as little as one month of exposure to antipsychotics and other dopamine receptor blocking agents. The involuntary movements of tardive dyskinesia can also have a substantial impact on older adults, affecting their balance, gait, ability to swallow and respiratory conditions.
'These data show that participants 65 years and older achieved clinically meaningful improvements in tardive dyskinesia symptoms within eight weeks of INGREZZA treatment, with substantial and sustained improvement up to 48 weeks, adding to the breadth of evidence suggesting INGREZZA is uniquely suitable for this patient population,' said Eiry Roberts, Chief Medical Officer, Neurocrine Biosciences.
The pooled post-hoc analysis included 304 participants across studies who received a once-daily dose of INGREZZA (40 mg or 80 mg) for up to 48 weeks. Of the total participants, 55 (18.1%) were 65 years and older. At Week 48, efficacy and safety outcomes were analyzed by dose (40 mg, 80 mg) and age (<65 years, ?65 years).
Overall, psychiatric stability was maintained through 48 weeks of treatment and INGREZZA was generally well tolerated. The most common treatment-emergent adverse events reported from Weeks 8 to 48 included urinary tract infection and somnolence; each occurred in six of the 55 participants who were 65 years and older, the company said.
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