drugs for overactive bladder (OAB)

Versameb AG Announces FDA Clearance of IND Application for VMB-100 in the Treatment of Stress Urinary Incontinence

Versameb AG (“Versameb”), a pre-clinical stage company focused on transforming RNA therapeutics to treat unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application of VMB-100, a potency enhanced messenger ribonucleic acid (mRNA) encoding human insulin-like growth factor-1 (IGF-1), for the treatment of stress urinary incontinence (SUI).  Following this clearance, Versameb plans to launch a Phase 2a open label, first-in-human dose ascending study in the first half of 2024. The study will evaluate the safety, tolerability, and efficacy of VMB-100 in female subjects with stress urinary incontinence, a highly common condition resulting in involuntary leakage of urine due to a weakened urinary sphincter muscle. Read more.

Source: Pharmaweb.com, November 17, 2023

business buildings

UroMems Granted Safer Technologies Program Designation from FDA for Smart Implant to Treat Stress Urinary Incontinence

UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that they have received Safer Technologies Program (STeP) designation from the U.S. Food and Drug Administration (FDA) for UroActive Smart Continence Therapy. STeP is a collaborative program intended to help reduce the time it takes to develop and obtain marketing authorization for eligible devices. Read more.

Source: PRNewswire, April 20, 2023

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

pelvic vaginal mesh stress urinary incontinence Polypropylene vaginal mesh

FDA Halts All Sales of Pelvic Mesh Products Tied to Injuries in Women

The U.S. Food and Drug Administration on Tuesday announced a ban on the sale of all pelvic mesh products.  The surgical mesh is typically used to repair pelvic organ prolapse (POP) and incontinence, but reported side effects have included permanent incontinence, severe discomfort and an inability to have sex.  “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.” Read more.

Source: HealthDay News, April 16, 2019

women exercising

FDA Grants DeNovo Clearance to Atlantic Therapeutics for INNOVO® Therapy Device to Treat Stress Urinary Incontinence

Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, announced today (13.11.18) that the U.S. Food and Drug Administration (FDA) has granted a DeNovo clearance for its INNOVO® therapy device, an externally worn electrical muscle stimulator for the treatment of stress urinary incontinence in adult females. INNOVO® is the first transcutaneous electrical stimulation continence device to be cleared by the FDA, following results of two randomized controlled trials (RCTs) demonstrating it to be an effective and low-risk device for the treatment for stress urinary incontinence (SUI) in adult females.  Read more.

Source: Business Wire, November 13, 2018

women friends

FDA Warns About ‘Deceptive’ Vaginal Rejuvenation Claims

Procedures marketed to improve a woman’s “intimate health” using lasers or ultrasound are not only unapproved, but are also causing burns and other painful damage, the Food and Drug Administration said Monday. The FDA has warned seven companies that are promoting their devices for these procedures, and issued a general alert for patients and doctors. The agency has also warned the public against asking for such procedures.  The laser and ultrasound equipment used in these unapproved procedures has FDA approval for removing genital warts, other growths and in operations such as hysterectomies. But they have not been shown to tighten up muscles, increase sexual pleasure or relieve pain during intercourse, the FDA said. Read more.

Source: NBC News, July 30, 2018