INGREZZA (valbenazine) Capsules Non-Responders in the Tardive Dyskinesia (TD) Clinical Development Program

Thank you for contacting Neurocrine Biosciences with your unsolicited Medical Information request regarding the percentage of participants defined as not responding to INGREZZA (valbenazine) capsules (“non-responders”) in the tardive dyskinesia (TD) clinical development program.

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

There is no formal definition of response in tardive dyskinesia as the clinical presentation of the condition is variable, with severity and impact differing for each patient. In lieu of a “non-responder analysis,” Figure 1 (below) demonstrates the cumulative percentages of subjects, by study arm, who achieved certain thresholds of TD reduction in the double-blind, placebo-controlled portion of the pivotal KINECT 3 study as measured by the Abnormal Involuntary Movement Scale (AIMS) total score.2

The safety of valbenazine was evaluated in 3 placebo-controlled studies, each 6 weeks in duration including a total of 445 patients. During the three studies, the adverse reactions reported at ≥2% and >placebo were somnolence (somnolence, fatigue, sedation) (10.9% vs. 4.2%), anticholinergic effects (dry mouth, constipation, disturbance in attention, vision blurred, urinary retention) (5.4% vs. 4.9%), balance disorders/fall (4.1% vs. 2.2%), headache (3.4% vs. 2.7%), akathisia (2.7% vs. 0.5%), vomiting (2.6% vs. 0.6%), nausea (2.3% vs. 2.1%) and arthralgia (2.3% vs. 0.5%) for the INGREZZA and placebo groups, respectively.1

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. Hauser RA et al. KINECT 3: a phase 3 randomized, double-blind, placebo-controlled trial of valbenazine for tardive dyskinesia. Am J Psychiatry. 2017;doi:10.1176/appi.ajp.2017.16091037

Enclosures:

  1. INGREZZA [package insert]. Neurocrine Biosciences, Inc., San Diego, CA; 2017.
  2. Important Safety Information. Neurocrine Biosciences, Inc., San Diego, CA; 2017.

MED-MI-TD-US-0074

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