INGREZZA® (valbenazine) capsules received FDA approval on April 11, 2017, becoming the first medicine approved in the United States for the treatment of adults with tardive dyskinesia (TD), an involuntary movement disorder. The approval of INGREZZA was based on data from the KINECT 3 study, a Phase III, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study comparing once-daily INGREZZA 80mg and 40mg to placebo over six weeks in patients with moderate to severe tardive dyskinesia and an underlying schizophrenia, schizoaffective disorder or mood disorder. For more information on INGREZZA, please visit www.INGREZZA.com.
INGREZZA was also evaluated in KINECT 4, an open-label, one-year Phase III safety and efficacy study of once-daily INGREZZA 40mg and 80mg doses in patients with moderate to severe TD and clinical diagnoses of schizophrenia, schizoaffective disorder or mood disorder. Primary results from the KINECT 4 study were reported in December 2017. Additional analyses are ongoing.
Neurocrine Biosciences is also conducting RE-KINECT, the largest real-world dyskinesia screening study, which was designed to better understand the potentially broad-reaching impact of symptoms of possible TD in patients treated with antipsychotic medications. Initial results from the study showed that 28 percent of patients who were clinically evaluated were determined to have clinician-confirmed possible TD. More than 50 percent of patients had movements impacting two or more body regions, including the upper and lower limbs, neck and trunk (not just the face and mouth). Additional analyses are ongoing.
Additionally, Neurocrine Biosciences is conducting a Phase IV post-marketing study (Kinected 2) to evaluate the potential for clinical dependence and withdrawal symptoms associated with INGREZZA. For more information on the Kinected 2 study, please visit www.kinected2.com.
Congenital Adrenal Hyperplasia
Neurocrine Biosciences is conducting a Phase II proof-of-concept study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of NBI-74788 in adult patients with classic congenital adrenal hyperplasia (CAH). The interim results from this ongoing open-label, multiple-dose, dose-escalation study were reported in March 2019. For more information on this Phase II study of NBI-74788 in CAH (CAHlibrate), please visit www.cahlibratestudy.com/.
VY-AADC is currently being evaluated in the Phase II RESTORE-1 trial in patients who have been diagnosed with Parkinson’s disease for at least four years, are not responding adequately to oral medications, and have at least three hours of OFF time during the day, as measured by a validated self-reported patient diary. For more information about the RESTORE-1 clinical trial, please visit restore1study.com.
VY-AADC is being developed by Neurocrine Biosciences and Voyager Therapeutics as part of a strategic collaboration announced in January 2019.
New VMAT2 Inhibitor
Neurocrine Biosciences filed an Investigational New Drug (IND) application and completed dosing in the single ascending dose portion of a Phase I study designed to assess initial safety, tolerability and pharmacokinetics of a novel, internally discovered VMAT2 inhibitor. This compound has the potential to be used in the treatment of several neurology and/or psychiatry disorders. The multiple dosing portion of this Phase I study is ongoing and is expected to be completed during the first half of 2019.
Novel CNS Compound
Neurocrine Biosciences filed an IND application and completed dosing in a Phase I single ascending dose study for an internally discovered first-in-class CNS compound with potential use in the treatment of several neurology and/or psychiatry disorders. The study is a randomized, double-blind, single ascending dose study to evaluate the safety, tolerability and pharmacokinetic profile of the compound in healthy participants. Additional analyses of the data from this study are ongoing to inform the design of future clinical studies for the program.
Policy on expanded access to investigational medicines
Individuals interested in participating in clinical trials for Neurocrine Biosciences’ products may visit the “Pipeline” section of the website for information on ongoing clinical trials. At this time, Neurocrine Biosciences does not have an expanded access program that allows patients to have access to the Company’s investigational products prior to FDA approval. Neurocrine Biosciences will update this page as the Company grows and reassesses the approach to expanded access programs. If you have any questions, please contact firstname.lastname@example.org.