Discontinuation of INGREZZA (valbenazine) Capsules

Thank you for contacting Neurocrine Biosciences with your unsolicited Medical Information request regarding discontinuation of INGREZZA® (valbenazine) capsules.

INGREZZA is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia.1

There are no requirements in the INGREZZA FDA-approved full prescribing information for titration when discontinuing INGREZZA.

In the KINECT 3 study, subjects demonstrated sustained reductions in TD severity (as measured by the mean change in abnormal involuntary movement scale [AIMS] total dyskinesia score) through 48 weeks of treatment (Figure 1). Following discontinuation of valbenazine treatment (patients were taken off drug from Weeks 48-52), the mean AIMS dyskinesia total scores returned towards baseline levels.1,2

This letter and the enclosed material are provided in response to your unsolicited medical information inquiry. Please feel free to contact Neurocrine Medical Information at (877) 641-3461 or medinfo@neurocrine.com if you would like to request additional information.

References:

  1. INGREZZA [package insert]. Neurocrine Biosciences, Inc., San Diego, CA; 2017.
  2. Grigoriadis, D., Remington, G., Comella, C.L., et al. Efficacy of Valbenazine (NBI-98854) in Subjects with Tardive Dyskinesia: Results of a Long-Term Extension Study (KINECT 3 Extension). Presented at the 55th Annual Meeting of the American College of Neuropsychopharmcology. December 4-8, 2016; Hollywood, Florida.

Enclosures:

  1. INGREZZA [package insert]. Neurocrine Biosciences, Inc., San Diego, CA; 2017.
  2. Important Safety Information. Neurocrine Biosciences, Inc., San Diego, CA; 2017.
  3. Grigoriadis, D., Remington, G., Comella, C.L., et al. Efficacy of Valbenazine (NBI-98854) in Subjects with Tardive Dyskinesia: Results of a Long-Term Extension Study (KINECT 3 Extension). Presented at the 55th Annual Meeting of the American College of Neuropsychopharmcology. December 4-8, 2016; Hollywood, Florida.

MED-MI-TD-US-0076

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