Valbenazine and Underlying Psychiatric Disorders

Thank you for contacting Neurocrine Biosciences with your unsolicited Medical Information request regarding the effect of underlying psychiatric disorder (mood disorder or schizophrenia/schizoaffective disorder) on tardive dyskinesia response to INGREZZA (valbenazine) capsules.

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

Valbenazine in Patients with Tardive Dyskinesia and Mood Disorder:

The long-term use of valbenazine (VBZ) in patients with tardive dyskinesia and mood disorder was evaluated in the KINECT 3 valbenazine extension (VE) period (Correll 2017, Correll 2017, and Josiassen 2017, enclosed).2,3,4

At Week 48, AIMS mean score changes from double-blind placebo controlled (DBPC) baseline were -5.8 and -4.2, respectively, for the VBZ 80 and 40 mg/day dose groups. The mean AIMS scores changes from baseline at Week 52 (during the 4-week period following discontinuation of VBZ) were -1.6 and -2.7 for the 80 and 40 mg/dose groups, respectively (Figure 1). At Week 48, the mean Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) scores were 2.0 and 2.2, respectively, for the VBZ 80 and 40 mg/day groups. The mean CGI-TD scores at Week 52 increased to 3.5 and 2.8 for the VBZ 80 and 40 mg/day groups, respectively.2,3

In the DBPC and VE periods respectively, the incidence of treatment-emergent adverse events (TEAEs) in the overall safety population was 44.9% and 69.2%, and the discontinuation due to TEAEs was 5.7% and 15.7%.2 In the pooled long-term safety data, the 3 most commonly reported TEAEs for the mood disorder subgroup (n=121) were headache (12.4%), urinary tract infection (10.7%), and somnolence (9.1%). Mean psychiatric scales scores (Young Mania Rating Scale, YMRS; and Montgomery-Asberg Depression Rating Scale, MADRS) generally remained stable in patients with tardive dyskinesia and mood disorder during long-term VBZ treatment.4

Valbenazine in Patients with Tardive Dyskinesia and Schizophrenia/Schizoaffective Disorder:
The long-term use of VBZ in patients with tardive dyskinesia and schizophrenia or schizoaffective disorder was evaluated in the KINECT 3 VE period (Kane 2017, Kane 2017 and Josiassen 2017, enclosed).4,5,6

At Week 48, AIMS mean score changes from the DBPC baseline were -4.2 and -2.5, respectively, for the VBZ 80 and 40 mg/day dose groups. The mean AIMS score changes from baseline at Week 52 (during the 4-week period following discontinuation of VBZ) were -1.0 and -0.8 for the 80 and 40 mg/day dose groups, respectively (Figure 2). At Week 48, the mean CGI-TD scores were 2.2 and 2.4, respectively, for the VBZ 80 and 40 mg/day groups. The mean CGI-TD scores at Week 52 increased to 3.4 and 3.3 for the VBZ 80 and 40 mg/day groups, respectively.5,6

In the pooled long-term safety data, the 3 most commonly reported TEAEs for the schizophrenia/schizoaffective disorder subgroup (n=309) were urinary tract infections (6.1%), headache (5.8%) and somnolence (5.2%). Mean psychiatric scales scores (Positive and Negative Syndrome Scale, PANSS; and Calgary Depression Scale for Schizophrenia, CDSS) generally remained stable in patients with tardive dyskinesia and schizophrenia or schizoaffective disorder during long-term VBZ treatment.4

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. Correll CU et al. Long-Term Effects of Valbenazine (NBI-98854) in Subjects with Tardive Dyskinesia and Mood Disorder. Poster presented at the annual meeting of The College of Psychiatric and Neurologic Pharmacists; April 22-26, 2017; Phoenix, AZ.
  3. Correll CU et al. Efficacy of Valbenazine (NBI-98854) in Treating Subjects with Tardive Dyskinesia and Mood Disorders. Poster presented at the annual meeting of the American Psychiatric Association; May 20-24, 2017; San Diego, CA.
  4. Josiassen RC et al. Long-Term Safety and Tolerability of Valbenazine (NBI-98854) in Subjects with Tardive Dyskinesia and a Diagnosis of Schizophrenia or Mood Disorder. Poster presented at the annual meeting of the American Psychiatric Association; May 20-24, 2017; San Diego, CA.
  5. Kane JM et al. Long-Term Effects of Valbenazine (NBI-98854) in Subjects with Tardive Dyskinesia and Schizophrenia or Schizoaffective Disorder. Poster presented at the annual meeting of The College of Psychiatric and Neurologic Pharmacists; April 22-26, 2017; Phoenix, AZ.
  6. Kane JM et al. Efficacy of Valbenazine (NBI-98854) in Treating Subjects with Tardive Dyskinesia and Schizophrenia or Schizoaffective Disorder. Poster presented at the annual meeting of the American Psychiatric Association; May 20-24, 2017; San Diego, CA.

Enclosures:

  1. INGREZZA [package insert]. Neurocrine Biosciences, Inc., San Diego, CA; 2017.
  2. Important Safety Information. Neurocrine Biosciences, Inc., San Diego, CA; 2017.
  3. Correll CU et al. Long-Term Effects of Valbenazine (NBI-98854) in Subjects with Tardive Dyskinesia and Mood Disorder. Poster presented at the annual meeting of The College of Psychiatric and Neurologic Pharmacists; April 22-26, 2017; Phoenix, AZ.
  4. Correll CU et al. Efficacy of Valbenazine (NBI-98854) in Treating Subjects with Tardive Dyskinesia and Mood Disorders. Poster presented at the annual meeting of the American Psychiatric Association; May 20-24, 2017; San Diego, CA.
  5. Josiassen RC et al. Long-Term Safety and Tolerability of Valbenazine (NBI-98854) in Subjects with Tardive Dyskinesia and a Diagnosis of Schizophrenia or Mood Disorder. Poster presented at the annual meeting of the American Psychiatric Association; May 20-24, 2017; San Diego, CA.
  6. Kane JM et al. Long-Term Effects of Valbenazine (NBI-98854) in Subjects with Tardive Dyskinesia and Schizophrenia or Schizoaffective Disorder. Poster presented at the annual meeting of The College of Psychiatric and Neurologic Pharmacists; April 22-26, 2017; Phoenix, AZ.
  7. Kane JM et al. Efficacy of Valbenazine (NBI-98854) in Treating Subjects with Tardive Dyskinesia and Schizophrenia or Schizoaffective Disorder. Poster presented at the annual meeting of the American Psychiatric Association; May 20-24, 2017; San Diego, CA.

MED-MI-TD-US-0078

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