-
- Vibegron met both co-primary endpoints demonstrating highly
significant reduction in daily urge urinary incontinence episodes and
micturitions, compared to placebo (p<0.0001 and p<0.001, respectively)
- Vibegron met both co-primary endpoints demonstrating highly
-
- Vibegron met all seven key secondary endpoints, including a
clinically meaningful reduction in daily urgency episodes versus
placebo (p=0.002)
- Vibegron met all seven key secondary endpoints, including a
-
- Vibegron achieved rapid onset at two weeks in both co-primary
endpoints and daily urgency episodes (p<0.001 for these endpoints) and
statistically significant efficacy was maintained at all timepoints
measured through the end of the study
- Vibegron achieved rapid onset at two weeks in both co-primary
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- Vibegron could potentially be the first new prescription drug in
nearly a decade for the millions of patients suffering from overactive
bladder (OAB)
- Vibegron could potentially be the first new prescription drug in
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- Urovant to host investor conference call March 19, 2019
IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Urovant Sciences (Nasdaq: UROV), a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for urologic conditions, today announced positive
topline results from EMPOWUR, an international double-blind,
placebo-controlled, multicenter Phase 3 clinical trial evaluating the
efficacy and safety of vibegron 75mg in adults with symptoms of
overactive bladder. Vibegron is an investigational once-daily oral
beta-three adrenergic agonist.
In the primary efficacy analysis, once-daily vibegron met the co-primary
endpoints at week 12, achieving statistical significance over placebo on
both reduction in daily urge urinary incontinence (UUI) episodes
(p<0.0001) and reduction in daily micturitions (p<0.001). The difference
from placebo was statistically significant as early as week 2, which was
the first timepoint measured, for both UUI episodes and micturitions
(p<0.0001 and p<0.001, respectively), and statistically significant
efficacy was maintained at all timepoints measured through the end of
the study for both endpoints. Additionally, at all measured timepoints,
vibegron achieved numerically better efficacy than tolterodine, the
active control in this study, which is a currently available OAB
treatment.
All seven pre-specified key secondary endpoints were met, including a
statistically significant reduction in daily urgency episodes compared
to placebo (p=0.002). Other endpoints that were not part of the topline
data analysis will be presented at future medical meetings.
Vibegron was well tolerated and the most common adverse events reported
versus placebo (>2% in vibegron and greater than placebo) were headache
(4.0% vs 2.4%), nasopharyngitis (2.8% vs 1.7%), diarrhea (2.2% vs 1.1%),
and nausea (2.2% vs 1.1%). The frequency of serious adverse events was
similar across treatment arms (1.1% in placebo, 1.5% in vibegron, and
2.3% in tolterodine). The incidence of the reported adverse event of
hypertension was equal to placebo (1.7% in vibegron, 1.7% in placebo,
and 2.6% in tolterodine). Full vital sign data, including blood
pressure, were not part of the topline data analysis.
Based on these topline results, Urovant intends to file a New Drug
Application (NDA) with the U.S. Food and Drug Administration (FDA) by
early 2020. EMPOWUR results will be presented at the American Urological
Association Annual Meeting in Chicago in May of this year.
“There is a significant need for innovative new treatment options for
OAB patients, as many patients are unable to find relief with currently
available medicines,” said Dr. David R. Staskin, a key investigator in
the EMPOWUR study, a leading urologist with St. Elizabeth’s Medical
Center, and an Associate Professor of Urology at Tufts University School
of Medicine in Boston. “The strong efficacy and safety topline results
from the EMPOWUR study suggest that vibegron, if approved by the FDA,
could provide an exciting next-generation treatment option for patients
suffering from OAB.”
“We believe these efficacy and safety results represent a significant
advancement in the treatment of OAB, positioning vibegron as a potential
best in class therapy,” said Keith A. Katkin, Chief Executive Officer of
Urovant. “Vibegron, if approved, could potentially be the first new
prescription drug in nearly a decade for the millions of women and men
suffering from OAB.”