Neurocrine Biosciences, Inc. Announces Top-Line Results from Phase II T-Forward Study of INGREZZA™
January 17, 2017 at 09:01 pm
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Neurocrine Biosciences, Inc. announced the top-line results from the company's Phase II T-Forward study of INGREZZA™ (valbenazine), a highly-selective small molecule Vesicular Monoamine Transporter 2 (VMAT2) inhibitor, in adults with Tourette syndrome. While the study showed a significant improvement in overall symptoms of Tourette syndrome as evidenced by the Clinical Global Impression of Change (p=0.015), the pre-specified primary endpoint, the change-from-baseline in the Yale Global Tic Severity Scale (YGTSS) at Week 8 was not met (p=0.18). Adverse events were dose dependent and consistent with earlier clinical studies. The T-Forward study was a randomized, double-blind, placebo-controlled, multi-dose, parallel group, Phase II study to evaluate the safety, tolerability and efficacy of valbenazine in adults with moderate to severe Tourette syndrome. Two once-daily fixed doses of valbenazine were evaluated vs. placebo in a 1:1:1 randomization. The three-arm study evaluated 124 patients over eight weeks of dosing followed by two weeks off-drug at 32 study centers in the United States. The primary endpoint of this study was a change from baseline of placebo vs. active scores utilizing the YGTSS at the end of Week 8. Tourette symptoms were also evaluated via the Premonitory Urge for Tics Scale as well as the Clinical Global Impression of Change scale, among others.
Neurocrine Biosciences, Inc. is a neuroscience-focused, biopharmaceutical company. The Company is engaged in discovering and developing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. Its diverse portfolio includes the United States Food and Drug Administration-approved treatments for tardive dyskinesia, chorea associated with Huntingtonâs disease, endometriosis and uterine fibroids, as well as a robust pipeline, including multiple compounds in mid-to late-phase clinical development across its core therapeutic areas. Its commercial products include INGREZZA, ALKINDI, EFMODY, Orilissa and Oriahnn. INGREZZA is marketed as DYSVAL (valbenazine) in Japan and REMLEAS (valbenazine) in other select Asian markets, where Mitsubishi Tanabe Pharma Corporation retains commercialization rights. ALKINDI is marketed as ALKINDI SPRINKLE (hydrocortisone) in the United States, where Eton Pharmaceuticals, Inc. retains commercialization rights.
NEUROCRINE BIOSCIENCES, INC. 
