product approval introduction

Urovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)

Urovant Sciences, Inc (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. Read more.

Source: BioSpace, December 23, 2020

female doctor

Vibegron Update Shared as FDA Weighs Approval in OAB

The FDA is considering an application for vibegron for the treatment of patients with OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency. Vibegron continued to demonstrate improved clinical outcomes versus tolterodine in patients with overactive bladder (OAB), according to findings from an extension study of the phase 3 EMPOWUR trial presented during the 2020 International Continence Society (ICS) online meeting. The extension results showed that at week 52, 61% of patients receiving vibegron had a 75% or higher reduction in urge urinary incontinence (UUI) episodes compared with 54.5% of patients who received tolterodine. Additionally, 40.8% versus 34.2% of patients, respectively, had a 100% reduction in UUI episodes and experienced no incontinence episodes over a 7-day diary.  Read more. 

Source: Urology Times, November 20, 2020

product approval introduction

Axonics® Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation System for Urinary Clinical Indications

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (“SNM”) devices for the treatment of bladder and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”) for the clinical indications of overactive bladder (“OAB”) and urinary retention. The FDA premarket approval (“PMA”) grants Axonics the right to market its product in the United States for the clinical indications of OAB (urinary urge incontinence and urinary urge frequency) as well as urinary retention, representing the largest segment of the market for SNM devices. The FDA approval follows the Company’s September approval for the clinical indication of fecal incontinence, which, according to published clinical studies, is a co-morbidity reported by as many as a third of patients presenting with urinary urge incontinence. Read more.

Source: Business Wire, November 14 2019

hurrying with overactive bladder

Innovus Pharma Announces the Publication of a Successful Clinical Trial in Overactive Bladder and Urine Incontinence Patients for its UriVarx® Product

Innovus Pharmaceuticals, Inc. (“Innovus Pharma” or the “Company”) (OTCQB Venture Market: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women’s health and respiratory diseases, today announced that the human clinical trial for the patented formulation in its product UriVarx® product for bladder health was published in the peer reviewed journal, BMC Complementary and Alternative Medicine (Schoendorfer et al. BMC Complementary and Alternative Medicine (2018) 18:42). The study was conducted by the team of Dr. Niikee Schoendorfer in Australia in collaboration with the Company’s UriVarx® licensing partner Seipel Group, Ltd. The outcome of this study demonstrated both statistical significance and clinical relevance in reducing symptoms of Overactive Bladder (“OAB”), urinary frequency and/or urgency and incontinence. Read more.

Source: Digital Journal, February 7, 2018

sleep woman nocturia

Sleep Quality Improves with Help of Incontinence Drug

A drug used to curtail episodes of urinary incontinence in women also improves quality of sleep, a researcher at the Stanford University School of Medicine reports.  People who experience urinary incontinence, especially at night, often have trouble maintaining normal sleep cycles. Now, the Stanford researcher sees promise in using one drug to help remedy both problems.  “Two of the biggest quality-of-life factors for older women are poor sleep quality and incontinence, and the older you get, the more prevalent both conditions are, and they do seem to be correlated,” said Leslee Subak, MD, professor and chair of obstetrics and gynecology. “And so, if we can find a drug to treat one and effectively decrease the other too, that could be big for improving quality of life.”  Read more.

Source: Stanford Medicine News Center, January 11, 2018

You may also with to read:  Incontinence Drug May Help Sleep Dysfunction in Older Women

operating room surgery

StimGuard Enrolls First Patient in Office-Based Chronic Tibial Nerve OAB Incontinence Stimulation Study Utilizing the World’s Smallest Wireless System

StimGuard, a privately-held, pre-commercial stage medical device company, today announced the initiation and the first patient enrollment in a clinical trial of the world’s first miniature implantable device for the treatment of urgency urinary incontinence resulting from refractory overactive bladder (OAB) syndrome. The StimGuard device utilizes wireless technology and is placed through an introducer device the size of a needle at the tibial nerve to activate the afferent micturition (neural urinary) pathways. The clinical trial of this novel approach will launch this winter. Read more.

Source: Business Wire, December 15, 2016

female doctor

Botox Beats Implant for Urinary Incontinence in Women

For women with bladder incontinence who haven’t been helped by medications or other therapies, Botox injections may help control leakage better than an implanted nerve stimulation device, a new study suggests. However, both treatments are effective, according to doctors who treat the condition. In a head-to-head comparison, women given Botox saw their number of daily urgency incontinent episodes decrease by four, on average, compared to three for women who received the implant, called InterStim.  Botox patients also said they had a greater reduction in symptoms and were more satisfied with the treatment, the researchers said.  Read more.

Source: HealthDay News, October 4, 2016