Mirabegron Granted Priority Review for Neurogenic Detrusor Overactivity
The submissions are supported by data from a phase 3 study that evaluated mirabegron in 91 patients aged 3 to 17 years with NDO on clean intermittent catheterization.
Overactive Bladder/Enuresis
Gemtesa Approved for Overactive Bladder Treatment
The approval was based on data from the pivotal phase 3 EMPOWUR study.
Anticholinergics Linked to Increased Dementia Risk
Physicians should carefully weigh the risks against the potential benefits before prescribing anticholinergics, according to investigators.
OAB Drug May Improve Outcomes in Botulinum Toxin Recipients
Pharmacologic therapy may improve symptoms in patients with refractory overactive bladder who receive intravesical onabotulinum toxin-A injections.
Intravaginal Home-Use Device Cleared for Stress Urinary Incontinence
Flyte is an in-home treatment designed to strengthen and treat weakened pelvic floor muscles.
Vesicare LS Approved for Neurogenic Detrusor Overactivity
The FDA has approved Vesicare LS (solifenacin succinate; Astellas Pharma) oral suspension for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 2 years of age and older.
Next-Gen Rechargeable Neurostimulator Implant Approved for Urinary, Bowel Dysfunction
The FDA has approved a new version of Axonics Modulation’s rechargeable implantable sacral neurostimulator (r-SNM) system that allows patients to decrease the frequency of charging to once a month.
Anticholinergic Meds for Overactive Bladder May Up Dementia Risk
Among patients with overactive bladder (OAB), anticholinergic medication use appears to be associated with an increased risk of new onset dementia when compared with beta-3 agonist use, according to the findings of a retrospective population-based cohort study.
Vibegron Under Review for Overactive Bladder Treatment
The FDA has accepted for review the New Drug Application for vibegron (Urovant Sciences) for the treatment of patients with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
NDA Submitted for Vibegron for Overactive Bladder Treatment
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…
