Pharmacokinetics, safety and tolerability of valbenazine in Korean CYP2D6 normal and intermediate metabolizers

Chung, Wook-Sung; Hwang, Inyoung; Kim, Byungwook; Jung, Jin Tae; Yu, Kyung‐Sang; Jang, In‐Jin; Oh, Jaeseong

doi:10.1111/cts.13466

Cited by 4 publications

(3 citation statements)

References 18 publications

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“…This suggests that racial differences, that is, Asian versus Western populations, do not seem to influence the efficacy or safety of valbenazine. Moreover, a recent pharmacokinetic study reported similar plasma concentrations of valbenazine after administration in Korean and North American populations; thus, it is likely that exposure responses after administration of valbenazine are also similar between Asians and North Americans 27 …”

Section: Discussionmentioning

confidence: 94%

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Efficacy and Safety of Valbenazine in Japanese Patients With Tardive Dyskinesia and Schizophrenia/Schizoaffective Disorder or Bipolar Disorder/Depressive Disorder

Nagano,

Susuta,

Masui

et al. 2024

J Clin Psychopharmacol

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Purpose This post hoc analysis investigated whether a patient's underlying psychiatric disease (schizophrenia/schizoaffective disorder [SCHZ] or bipolar disorder/depressive disorder [MOOD]) influenced the efficacy or safety of valbenazine for tardive dyskinesia (TD) in an Asian population. Methods We analyzed data from J-KINECT, a multicenter, phase II/III, randomized, double-blind study, which consisted of a 6-week placebo-controlled period followed by a 42-week extension where Japanese patients with TD received once-daily 40- or 80-mg valbenazine. We compared the change from baseline in Abnormal Involuntary Movement Scale total score and Clinical Global Impression of TD score between patients with SCHZ and those with MOOD, and incidence of treatment-emergent adverse events. Results Of 256 patients included in the placebo-controlled period, 211 continued to the long-term extension. The mean change from baseline in Abnormal Involuntary Movement Scale total score at week 6 (95% confidence interval) was −1.8 (−3.2 to −0.5) and −3.3 (−4.7 to −1.9) in the valbenazine 40- and 80-mg groups, respectively (SCHZ group), and −2.4 (−3.9 to −0.9) and −3.5 (−5.1 to −1.9) in the valbenazine 40- and 80-mg groups, respectively (MOOD group), demonstrating improvement at either dose level over placebo, regardless of the underlying disease. These results were maintained to week 48, and improvements of Clinical Global Impression of TD scores were similar. There were no notable differences in the incidence of serious or fatal treatment-emergent adverse events by underlying disease; differences in the incidence of worsening schizophrenia and depression were attributed to underlying disease progression. Conclusions Safety and efficacy of long-term valbenazine therapy for TD did not vary according to underlying psychiatric disease.

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Section: Discussionmentioning

confidence: 94%

“…Moreover, a recent pharmacokinetic study reported similar plasma concentrations of valbenazine after administration in Korean and North American populations; thus, it is likely that exposure responses after administration of valbenazine are also similar between Asians and North Americans. 27…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Valbenazine in Japanese Patients With Tardive Dyskinesia and Schizophrenia/Schizoaffective Disorder or Bipolar Disorder/Depressive Disorder

Nagano,

Susuta,

Masui

et al. 2024

J Clin Psychopharmacol

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“…The main AEs include headache, diarrhea, dizziness, drowsiness, etc. (Chung et al, 2023). The most commonly reported AE in clinical trials was somnolence (80 mg: 5%, 40 mg: 4%, placebo: 4%), followed by sudden AEs (80 mg: 4%, 40 mg: 3%, placebo: 3%) (Hauser et al, 2016).…”

Section: Discussionmentioning

confidence: 99%

Mining and analysis of security alert signals of valbenazine based on the Food and Drug Administration Adverse Event Reporting System database

Wang,

Qu,

et al. 2024

J Psychopharmacol

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Background: Valbenazine is used for tardive movement disorders in adults. Current studies on its safety are mostly from clinical trials and small case reports, limiting information on rare adverse reactions. This study investigated valbenazine-related adverse event (AE) risk signals using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods: Valbenazine AEs data were collected from the FAERS database from 2017 Q2 to 2023 Q1, employing methods like reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network, and empirical Bayesian geometric mean. Results: After data cleaning and drug screening, there were 20,837 AEs primarily suspecting valbenazine, involving 26 system organ classes and 125 AEs related to valbenazine at the preferred terms level. AEs related to valbenazine were mainly concentrated in nervous system disorders, general disorders and administration site conditions, and psychiatric disorders. Eye disorders and gastrointestinal disorders are new AEs not labeled in the valbenazine instructions. In addition, some new potential AE signals were found, such as Tardive dyskinesia and eyelid function disorder. Conclusion: The common AEs of valbenazine in the real world are consistent with the instructions, but there are some newly discovered suspicious AEs.

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Rehmannioside A inhibits the activity of CYP3A4, 2C9 and 2D6 in vitro

Wang,

Zhou,

et al. 2024

Xenobiotica

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Pharmacokinetics, safety and tolerability of valbenazine in Korean CYP2D6 normal and intermediate metabolizers

Cited by 4 publications

References 18 publications

Efficacy and Safety of Valbenazine in Japanese Patients With Tardive Dyskinesia and Schizophrenia/Schizoaffective Disorder or Bipolar Disorder/Depressive Disorder

Efficacy and Safety of Valbenazine in Japanese Patients With Tardive Dyskinesia and Schizophrenia/Schizoaffective Disorder or Bipolar Disorder/Depressive Disorder

Mining and analysis of security alert signals of valbenazine based on the Food and Drug Administration Adverse Event Reporting System database

Rehmannioside A inhibits the activity of CYP3A4, 2C9 and 2D6 in vitro

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