WASHINGTON (dpa-AFX) - Neurocrine Biosciences Inc. (NBIX) announced data from the Phase IIb T-Force GOLD study demonstrating that valbenazine did not meet the primary endpoint as assessed by the Yale Global Tic Severity Scale or YGTSS in children and adolescents with moderate to severe Tourette syndrome. The types of treatment emergent adverse events observed in this trial were consistent with those seen in other valbenazine studies.
'We are very disappointed with the topline data from the T-Force GOLD study given that children and adolescents with Tourette syndrome need better treatment options. This study was well-conducted with a placebo response as expected, but the treatment effect of valbenazine was lower than we had anticipated,' said Kevin Gorman, Ph.D., Chief Executive Officer at Neurocrine Biosciences.
Neurocrine Biosciences continues to focus on developing treatments for neurological and endocrine related disorders. The company discovered, developed and markets INGREZZA (valbenazine) capsules, the first U.S. Food and Drug Administration (FDA) approved product indicated for the treatment of adults with tardive dyskinesia, an involuntary movement disorder.
In addition, as part of a collaboration with AbbVie, ORILISSA (elagolix) was approved in 2018 by the FDA for the treatment of endometriosis. Other clinical development programs include opicapone for Parkinson's disease patients, elagolix for uterine fibroids with AbbVie and NBI-74788 for the treatment of congenital adrenal hyperplasia or CAH.
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