Urovant Sciences has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for vibegron, a beta-3 adrenergic agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
The NDA submission includes data from an extensive clinical development program involving over 4000 patients with OAB. Results from the pivotal 12-week phase 3 EMPOWUR study support the efficacy and safety of vibegron in 1518 patients randomized to receive either vibegron 75mg once daily, placebo, or tolterodine extended-release 4mg once daily.
Findings from EMPOWUR showed that vibegron achieved a statistically significant reduction in daily urge urinary incontinence episodes (P <.0001) and daily micturitions (P <.001) compared with placebo (co-primary end points). Vibegron also met statistical significance for both co-primary end points as early as week 2 and statistically significant efficacy was maintained at all timepoints through the end of the study. Compared with tolterodine ER, treatment with vibegron led to numerically superior efficacy at all measured timepoints.
In addition, vibegron improved treatment benefit on key OAB symptoms over a 40-week extension study. At week 52, 61% of vibegron-treated patients achieved at least a 75% reduction in daily urge urinary incontinence episodes, while 41% reported no urge urinary incontinence episodes.
With regard to safety, vibegron demonstrated a favorable long-term safety and tolerability profile. The most common treatment-emergent adverse reactions were headache, nasopharyngitis, diarrhea, and nausea.
“Our NDA submission for vibegron is a significant milestone for our company and brings us one step closer to potentially providing a new oral therapy to a highly dissatisfied market,” said Keith Katkin, CEO of Urovant. “Vibegron, if approved next year, would be the first new branded prescription drug for the treatment of OAB in nearly a decade.”
The Company is also investigating vibegron for the treatment of OAB in men with benign prostatic hyperplasia (BPH) and for the treatment of abdominal pain associated with irritable bowel syndrome (IBS).
For more information visit urovant.com.