US FDA accepts New Drug Application for vibegron for the treatment of overactive bladder

The application is seeking approval for the use of a 75mg once daily dose for the treatment of patients with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. An application for approval in the EU has not yet been submitted.

SPS commentary:

Vibegron is an agonist of beta-3 adrenergic receptors which enhances bladder relaxation. In the Phase III EMPOWUR trial it was shown to decrease daily urge urinary incontinence episodes (by a mean of 2.0 episodes/day versus 1.4 for placebo; p<0.0001) and daily micturitions (by an adjusted mean of 1.8 episodes/day versus 1.3 for placebo; p<0.001). Although tolterodine 4mg was also used as a comparator, the formal efficacy analysis was the comparison of vibegron and placebo.


Biospace Inc.

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