Valbenazine (NBI-98854): An investigational treatment of Tourette syndrome
Tourette syndrome is a neurological disorder that manifests in early childhood or adolescence, consisting of involuntary motor and vocal tics. Tourette syndrome is more commonly diagnosed in males than females and may be associated with attention deficit hyperactivity disorder and obsessive compulsive disorder.
After an extensive preclinical program, Neurocrine explored valbenazine (NBI-98854) in an initial Tourette syndrome clinical trial, the T-Force study. This study was an open-label, multi-dose, two-week evaluation of 36 subjects with Tourette syndrome. Children and adolescents enrolled in the trial received once-daily dosing of valbenazine during a two-week treatment period to assess both the safety and tolerability of valbenazine in Tourette patients. Additionally, the Yale Global Tic Severity Scale and the Premonitory Urge for Tics Scale was employed during the study to assess the impact of valbenazine on the patients’ Tourette symptoms. In late 2015, the company initiated a Phase 2 study of valbenazine in adults with Tourette syndrome. Early in 2016, the company initiated a Phase 2 Study of valbenazine in children and adolescents with Tourette syndrome.