Myrbetriq Plus Pelvic Floor Exercises Fail to Ease Overactive Bladder

Combining Myrbetriq (mirabegron) with modifications like pelvic floor exercises failed to ease overactive bladder symptoms in people with Parkinson’s disease in a pilot clinical trial, the study’s main goal. But the treatment, approved for overactive bladder, when used with such behavioral modifications did increase the amount of urine patients were able to expel with each urination, relative to patients using only pelvic floor exercise. But this benefit was temporary. Read more.

Source: Parkinson’s News Today, December 7, 2022

Study Finds Vibegron Has No Adverse Ambulatory Effects in Patients with OAB

It is important for clinicians to perform ambulatory blood pressure monitoring (ABPM) for patients taking new prescribed medications, as they may affect blood pressure or heart rate in detrimental ways. It is especially important to monitor patients with overactive bladder (OAB), as this group has an increasing abundance of novel medicines available to them. In a recent study presented at the 2021 American Urological Association Annual Meeting,¹ Michael A. Weber, MD, and co-authors assessed the blood pressure and heart rate profiles of the beta 3 adrenergic receptor agonist vibegron (Gemtesa) in treating patients with OAB. Read more.

Source: Urology Times, November 5 2021

Urovant Sciences Announces U.S. Commercial Launch of GEMTESA® (vibegron) 75 mg Tablets for Patients with Overactive Bladder

Urovant Sciences, a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced the commercial launch of GEMTESA® (vibegron) 75 mg tablets, a beta-3 (β3) adrenergic receptor agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. Read more.

Source: Business Wire, April 12, 2021

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

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

Urovant Sciences Announces U.S. FDA Acceptance of New Drug Application for Vibegron for the Treatment of Overactive Bladder

Urovant Sciences (Nasdaq: UROV) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for once-daily 75 mg vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The NDA has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2020. In addition, the FDA has communicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application. Read more.

Source: Businesswire, March 5, 2020

TARIS Announces Presentation of Clinical Data for TAR-302 for Overactive Bladder

TARIS Bio™, a biopharmaceutical company developing transformational therapies to treat people with debilitating urological disorders, announced today that results of the company’s Phase 1b study of TAR-302 for the treatment of overactive bladder (OAB) will be presented in a podium session on Wednesday, September 4^th at the Annual Meeting of the International Continence Society (ICS) in Gothenburg, Sweden. The presentation will detail the safety, tolerability, pharmacokinetics and preliminary efficacy data including a durable benefit of TAR-302, which was administered to 11 OAB patients for six weeks. The abstract is available on the ICS website. Read more.

Source: PRNewswire, July 25, 2019

TARIS Bio Initiates New Clinical Study of TAR-302 in Overactive Bladder

TARIS Bio^™, a biopharmaceutical company developing transformational therapies to treat people with debilitating urological disorders, announced today the initiation of a new clinical investigation of TAR-302 for the treatment of overactive bladder (OAB). As a new follow-on arm of the company’s previously concluded Phase 1b trial, the study is designed to investigate the safety, tolerability, and preliminary efficacy of a single 12-week dose of the system, doubling the previous treatment experience and representing a duration that better meets the real-world needs of patients with this serious and chronic disease. Read more.

Source: Yahoo! Finance, May 1, 2019

First Big Test Approaches for Urovant

Investors who backed Urovant’s $140m flotation last September will soon find out whether the money was well spent. Before the end of March the company will release topline pivotal data on the overactive bladder project vibegron, a β3-adrenergic receptor agonist licensed from Merck & Co, and a positive result should allow regulatory filings to follow. It seems likely that the trial will hit: Merck successfully conducted a large phase IIb study of vibegron a few years ago, and a similar compound is already on the market in the shape of Myrbetriq, which has been sold by Astellas since 2011. This well-established product has only four years of US patent life left, so if Urovant has any chance of building vibegron into a similarly large product it needs to prove that its contender is both safer and more effective. Read more.

Source: Evaluate, March 12, 2019

FDA Approves Myrbetriq Combo Treatment for Overactive Bladder

The Food and Drug Administration (FDA) has approved Myrbetriq (mirabegron extended-release tablets; Astellas) in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. In clinical trials, the combination of Myrbetriq + solifenacin succinate was associated with greater improvements in the number of incontinence episodes per 24 hours (primary endpoint), the number of micturitions per 24 hours (primary endpoint), and the volume voided per micturition (secondary endpoint) compared to placebo or to individual active components. Long-term data also demonstrated that the effects of combination treatment were maintained throughout a 1-year treatment period. Read more.

Source: MPR, April 30, 2018