INGREZZA (valbenazine) Capsules and the Effect of Tardive Dyskinesia (TD) Duration on Treatment Outcomes

Thank you for contacting Neurocrine Biosciences with your unsolicited Medical Information request regarding INGREZZA® (valbenazine) capsules and the effect of tardive dyskinesia (TD) duration on treatment outcomes.

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

Data were pooled from three 6-week, randomized, double-blind, placebo-controlled trials of once-daily valbenazine in adults with TD (2 Phase 2 and 1 Phase 3: KINECT [NCT01688037], KINECT 2 [NCT01733121], and KINECT 3 [NCT02274558], respectively) to evaluate the effect of TD duration on TD outcomes. The mean change from baseline to week 6 in the Abnormal Involuntary Movement Scale (AIMS) total score was used to evaluate TD severity. Interpretation of this post-hoc analysis may be limited due to small sample size.2

The pooled population (n=373) included 32 (9%) subjects with <7 years of TD (80 mg, n=10; 40 mg, n=11, placebo [PBO], n=11) and 306 (91%) subjects (80 mg, n=79; 40 mg, n=94, PBO, n=133) with ≥7 years of TD. The mean baseline AIMS total scores ranged from 6 to 9 in the TD duration subgroup analyses. In subjects who had TD <7 years, the mean changes in AIMS total score from baseline to Week 6 were -2.9, – 0.6 and -0.1 for the 80 mg, 40 mg and PBO groups, respectively. For subjects who had TD ≥7 years, the changes in AIMS total score from baseline to Week 6 were -3.2, -2.1 and -0.4 for the 80 mg, 40 mg and PBO groups, respectively.2

Adverse reactions in the three placebo-controlled studies of 6-week duration reported at an incidence of >2% and greater than placebo were somnolence (10.9% and 4.2%, respectively), anticholinergic effects (5.4% and 4.9%), balance disorders/falls (4.1% and 2.2%), headache (3.4% and 2.7%,), akathisia (2.7% and 0.5%), vomiting (2.6% and 0.6%), nausea (2.3% and 2.1%) and arthralgia (2.3% and 0.5%), for valbenazine and placebo, respectively.1

For a more complete description of this analysis, please see attached data presentation from the 2017 Neuroscience Educational Institute Annual Congress by Meyer et al.

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. Meyer J et al. Effects of valbenazine on tardive dyskinesia: subgroup analyses of 3 randomized, double-blind, placebo-controlled trials. Poster presented at the 2017 Neuroscience Education Institute, Colorado Springs, CO

Enclosures:

  1. INGREZZA [package insert]. Neurocrine Biosciences, Inc., San Diego, CA; April 2017.
  2. Important Safety Information. Neurocrine Biosciences, Inc., San Diego, CA; April 2017.
  3. Meyer J et al. Effects of valbenazine on tardive dyskinesia: subgroup analyses of 3 randomized, double-blind, placebo-controlled trials. Poster presented at the 2017 Neuroscience Education Institute, Colorado Springs, CO

MED-MI-TD-US-0105

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