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

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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

drugs for overactive bladder (OAB)

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 4th 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

drugs for overactive bladder (OAB)

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

drugs for overactive bladder (OAB)

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

product approval introduction

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

drugs for overactive bladder (OAB)

Certain Common Medications Tied to 30% Higher Dementia Risk, Study Finds

Many older adults know that long-term use of certain medications can negatively affect cognition and increase one’s risk of dementia.  But a new study suggests that some classes of anticholinergic drugs — particularly those used to treat depression, Parkinson’s and urinary incontinence — carry a higher risk than others.  Anticholinergic drugs function by blocking the effects of acetylcholine, a chemical released by nerve cells to send signals to other nerves and muscles. They are prescribed to 20% to 50% of older adults in the United States to treat a variety of neurological, psychiatric, gastrointestinal, respiratory and muscular conditions, according to a 2009 study. In the UK, 34% to 48% of older adults take them, another study found.  Read more.

Source: CNN, April 25, 2018

drugs for overactive bladder (OAB)

Urovant Starts Pursuit of Astellas’ Overactive Bladder Drug Myrbetriq with New Phase 3 Trial

A little later than expected, Roivant group company Urovant has started its confirmatory phase 3 program for overactive bladder (OAB) drug vibegron, originally licensed from Merck & Co.  The pivotal trial—which was originally expected to get underway last year—will involve around 1,400 adults with symptoms of OAB such as urge urinary incontinence, urgency, and urinary frequency, according to Urovant.  The drug already has positive phase 2b and phase 3 data in hand, so if the latest trial is positive Urovant should be able to move ahead with regulatory filings. If approved, it could become a direct competitor to Astellas’ Myrbetriq (mirabegron), the first beta3-adrenergic agonist to reach the market for OAB. And that could present a big commercial opportunity: Astellas reported sales of its drug rose 30% to 93.1 billion yen ($876 million) in the nine months to end-January 2018 with take-up driven by greater tolerability than the widely used antimuscarinic OAB drug class. Read more.

Source: Fierce Biotech, March 28, 2018

drugs for overactive bladder (OAB)

Urinary Incontinence: What Pharmacists Should Know

Urinary incontinence (UI), the involuntary leakage of urine, is a frequent and problematic chronic condition for many patients. An estimated 10 to 30% of men and women are affected nationally, though this may be underestimated due to underdiagnoses and undertreatment.1-3 Often, patients who suffer with UI symptoms will develop poor self-rated health, depression, and mobility disability.4,5 This comorbid disease state also presents a substantial financial burden; data from 2014 found that in the United States alone, an estimated $65.9 billion in direct and indirect costs were spent for UI treatment.3  Read more.

Source: Drug Topics, January 23, 2018