Valbenazine (NBI-98854): Ongoing studies in Tardive Dyskinesia
KINECT 4 study
A one-year, open-label safety study of valbenazine (NBI-98854) has been initiated to support the anticipated 2016 filing of a New Drug Application in tardive dyskinesia. For information on the Kinect 4 study visit: www.kinect4study.com.
A Phase IIIb rollover study has been initiated to allow open-label access to valbenazine (NBI-98854) for subjects who completed either Kinect 3 or Kinect 4. The study is designed to allow access to valbenazine until such time as it is commercially available.
Neurocrine received Breakthrough Therapy Designation from the FDA for valbenazine in the treatment of tardive dyskinesia.