CAS No. : 1025504-45-3

Product Details
For research use only. Not Intended for Therapeutic Use!
Cat No:I000166
Synonyms:NBI-98854; NBI 98854; NBI98854; MT-5199; MT 5199; MT5199; Valbenazine
Molecular Formula:C24H38N2O4
Molecular Weight:418.57
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Appearance:Solid powder
Purity: > 98%
Cat No:I000166
Cas No:1025504-45-3

Valbenazine(cas 1025504-45-3) is a prodrug of the (+)-α isomer of tetrabenazine for tardive syndrome therapy, and inhibits VMAT2 function.

It is effective in regulating the levels of dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines. NBI-98854 is promising agent for the treatment of tardive dyskinesia. NBI-98854 significantly improved tardive dyskinesia and was well tolerated in patients. These results support the phase 3 clinical trials of NBI-98854 now underway.

1. Clin Schizophr Relat Psychoses. Summer 2017;11(2):113-119. doi: 10.3371/CSRP.OFGR.071717.
Valbenazine for Tardive Dyskinesia.
Freudenreich O, Remington G.
Tardive dyskinesia (TD) remains a clinical concern for any patient who receives an antipsychotic. While the overall risk of developing TD is lower with newer antipsychotics compared to older agents, a significant number of patients who require long-term treatment will develop TD. Recently, valbenazine (brand name Ingrezza) became the first drug to be approved by the FDA specifically for the treatment of TD. In this New Drug Review, we summarize the basic pharmacology and clinical trial results for valbenazine. Valbenazine is a modified metabolite of the vesicular monoamine transporter 2 (VMAT-2) inhibitor tetrabenazine, which is approved for the treatment of the hyperkinetic movement disorder, Huntington/'s disease. In short-term clinical trials, valbenazine at a dose of 80 mg/day improved TD, with an effect size that is clinically significant (d=0.90). The effect size for the 40-mg/day dose was lower (d=0.52). Compared to tetrabenazine, valbenazine has better clinical characteristics (i.e., once-a-day dosing, better short-term side effect profile). However, only long-term experience in routine clinical populations can delineate valbenazine/'s full benefits, optimal dosing, and risks not identified during short-term registration trials.
2. Int J Clin Pract. 2017 Jul;71(7). doi: 10.1111/ijcp.12964. Epub 2017 May 12.
Valbenazine for tardive dyskinesia: A systematic review of the efficacy and safety profile for this newly approved novel medication-What is the number needed to treat, number needed to harm and likelihood to be helped or harmed?
Citrome L(1).
Author information:
(1)New York Medical College, Valhalla, NY, USA.
OBJECTIVE: The objective of this systematic review was to describe the efficacy, tolerability, and safety of valbenazine for the treatment of tardive dyskinesia (TD).
DATA SOURCES: The pivotal registration trials were accessed by querying and, for the search terms /'valbenazine/' OR /'NBI-98854/', and by also querying the EMBASE (Elsevier) commercial database for clinical poster abstracts, and by asking the manufacturer for copies of posters presented at congresses. Product labeling provided additional information.
STUDY SELECTION: All available clinical reports of studies were identified. DATA EXTRACTION: Descriptions of the principal results and calculation of number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the available study reports and other sources of information.
DATA SYNTHESIS: Valbenazine, a reversible inhibitor of Vesicular Monoamine Transporter Type 2 (VMAT2), received approval for the treatment of TD in adults based on a clinical trial development programme that included three 6-week parallel group, randomised, placebo-controlled studies, including one Phase III trial described in product labeling. The recommended dose for valbenazine is 80 mg/d. The percentage of responders in the Phase III acute study, as defined by ≥50% reduction from baseline in the Abnormal Involuntary Movement Scale dyskinesia score was 40.0% for valbenazine 80 mg/d vs 8.7% for placebo, yielding a NNT of 4 (95% CI 3-6). As pooled from available data, discontinuation rates because of an adverse event were 2.9% for valbenazine-treated patients vs 1.6% for placebo-treated patients, resulting in a NNH of 76 (ns). The only adverse event that met the threshold of incidence ≥5% for valbenazine and a rate of ≥2 times than that observed with placebo was somnolence (somnolence, fatigue, sedation), with rates of 10.9% for valbenazine (all doses) vs 4.2% for placebo, resulting in a NNH of 15 (95% CI 9-52). An additional warning and precaution is that valbenazine can prolong the ECG QT interval, however, the valbenazine product label does not contain any bolded boxed warnings or contraindications. CONCLUSIONS: Valbenazine is presently the only US Food and Drug Administration-approved agent specifically indicated for the treatment of TD. Valbenazine is about 15 times more likely to result in a response than in a discontinuation because of an adverse event. Head-to-head comparisons with other VMAT2 inhibitors among patients with TD in the /'real world/' are needed.
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