Urovant Sciences Announces Positive Clinical Efficacy and Safety Data from Vibegron EMPOWUR Long Term Extension Study

  • Extension study demonstrates favorable results in long term treatment of overactive bladder with vibegron, including improvements in incontinence efficacy, quality of life endpoints, and with good tolerability
  • Long term EMPOWUR extension study data featured in an oral presentation at the virtual International Continence Society (ICS) Annual Meeting
  • Meta-analysis on increased risk of incident dementia following the use of anticholinergics will also be presented at ICS
San Francisco, CA (UroToday.com) -- Urovant Sciences announced positive efficacy and safety data from the vibegron EMPOWUR long term extension study with patient data over a total exposure of 52 weeks. The data demonstrate that vibegron improved quality of life (QoL) and incontinence efficacy endpoints with good long term tolerability in adult patients with overactive bladder (OAB) and symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency.

Vibegron is a once-daily, beta-3 adrenergic agonist under investigation for the treatment of OAB by the U.S. Food and Drug Administration (FDA). In March 2020, the FDA accepted the New Drug Application (NDA) for vibegron in OAB and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2020.

In an oral presentation at the virtual International Continence Society (ICS) Annual Meeting, David Staskin, MD, presented results from the 40-week EMPOWUR extension to the 12-week EMPOWUR trial that show 75 mg of vibegron was well tolerated over the total exposure of 52 weeks and demonstrated numerically greater improvements from baseline compared with tolterodine across QoL and responder efficacy endpoints. These results are consistent with the results from the placebo-controlled EMPOWUR phase 3 study, with comparable safety and durable efficacy.

“A large segment of the OAB population suffers in silence because they are embarrassed, afraid, or unaware that there are treatments, including medications, that could address their problems with bladder control. This situation leads to OAB being overlooked and undertreated, and highlights the need for therapeutic options to improve quality of life,” said Dr. Staskin, principal investigator of the EMPOWUR study, leading urologist with St. Elizabeth’s Medical Center, and Associate Professor of Urology at Tufts University School of Medicine, Boston. “The EMPOWUR 40-week extension study demonstrated how vibegron if approved by the FDA, has the potential to offer a lasting solution for adult patients with OAB to manage urinary frequency and urinary incontinence associated with the urgent need to go to the bathroom.”
At week 52, 61 percent of 143 vibegron-treated patients had a ≥75 percent reduction and 40.8 percent showed a 100 percent reduction in UUI (urge urinary incontinence), a key symptom for OAB patients. In addition, 71.1 percent had ≥50 percent reduction in total incontinence episodes from baseline to week 52. In this same time period, vibegron demonstrated numerically greater improvements from baseline versus tolterodine for all QoL subscale scores as measured by the Overactive Bladder Questionnaire Long Form (OAB-qLF), including coping, concern, sleep, social interaction, health-related QoL, and symptom bother. Vibegron 75 mg once daily demonstrated a 40-week safety profile comparable to that of the 12-week EMPOWUR study, as well as durable efficacy for QoL and incontinence efficacy endpoints. Adverse events (AEs) occurred in 62.6% (171/273) of vibegron and 54.3% (126/232) of tolterodine patients; 4 (1.5%) vibegron and 8 (3.4%) tolterodine patients discontinued study medication due to an AE.

Examining the Risk of Cognitive Effects Associated with Anticholinergic Agents

On November 20, there will be a presentation of findings from a recent meta-analysis of anticholinergic use by Dr. Roger Dmochowski, which was supported by Urovant. The systemic literature review and meta-analysis revealed that the use of anticholinergic agents for three months or longer increased the risk of incident dementia by an average of 46 percent relative to non-use. This increased risk also was reported in the six studies included in the meta-analysis that evaluated anticholinergic medications used to treat overactive bladder.

Anticholinergic medications are currently the most frequently prescribed pharmaceutical treatment for OAB. They exert their effects by blocking the action of the neurotransmitter acetylcholine and are prescribed to treat a wide range of medical conditions.

“The findings from our systematic literature review and meta-analysis shine a light on what data and anecdotal evidence has demonstrated for many practicing physicians: ongoing use of anticholinergics to treat OAB comes with an increased risk,” said Dr. Dmochowski, associate surgeon in chief and Professor of Urologic Surgery at Vanderbilt University Medical Center. “These findings underscore the need for medicines that can treat conditions such as OAB without the potential cognitive risks associated with anticholinergic agents. It is essential that health care providers work with their patients to determine an appropriate treatment plan."

Source: "Urovant Sciences Announces Positive Clinical Efficacy And Safety Data From Vibegron EMPOWUR Long Term Extension Study | Urovant Sciences". 2020. Urovant Sciences.

Related Content: 

SUFU 2020: Vibegron Statistically Significantly Improves Quality-of-Life Measures in Patients with Overactive Bladder: EMPOWUR Study
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