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Vibegron’s exposure-response relationship and the time course of pharmacodynamic response are not fully characterized.
In a 4-week, randomized, placebo-controlled, ambulatory blood pressure study in OAB patients (n=200), daily treatment with Vibegron 75 mg was not associated with clinically significant changes in blood pressure. Subjects enrolled in this study had a mean age of 59 years and 75% were female. Thirty-five percent of subjects had pre-existing hypertension at baseline and 29% of all subjects were taking at least 1 concomitant antihypertensive medication.
Cardiac Electrophysiology Vibegron does not prolong the QT interval to any clinically relevant extent at a single dose 5.3 times the approved recommended dose.
from FDA,2020.12
