Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
Urovant Sciences, a clinical-stage biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced that Kyorin Pharmaceutical Co., Ltd. (Kyorin) received marketing approval from Japan’s Ministry of Health, Labour and Welfare for vibegron for the treatment of adults with overactive bladder (OAB) in Japan. Kyorin licensed vibegron for Japan from Merck & Co., Inc. in 2014, and later expanded the license to include certain other Asian countries in 2017. Urovant licensed rights to vibegron for the United States and the rest of the world from Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. in 2017 and subsequently entered into a collaboration agreement with Kyorin later that year. Under the collaboration agreement, Urovant and Kyorin share information related to the development of vibegron, including clinical trial and nonclinical study data. Read more.
Source: The News, October 1, 2018
Sleepless nights can be costly. They interfere with daily activities and work productivity and leave one feeling tired and irritable. If left untreated, sleep loss can result in serious medical consequences. A leading cause of sleep loss is a medical condition called nocturia,1 which a staggering 72 percent of Americans have never heard about, according to a new national online survey of 2,040 U.S. adults conducted by The Harris Poll, and endorsed by Caregiver Action Network, National Association for Continence, Prostate Conditions Education Council, and The Simon Foundation for Continence. Nocturia forces individuals to get up more than once per night to urinate. Nocturia has many contributing causes, but in most cases, it is caused by the kidneys producing too much urine at night, known as nocturnal polyuria. The poll shows that while nocturia may affect more than a third of U.S. adults, 64 percent of Americans have no idea it is a diagnosable, treatable medical condition. Worse yet, 66 percent of nocturia sufferers2 surveyed have never talked to their doctor or healthcare professional about it. Half of those patients reported they thought it was a normal part of aging; 27 percent said they believed that nothing could be done about it. Read more.
Source: Global Newswire, September 12, 2018
A new group-administered behavioral treatment program was safe, cost-effective, reduced urinary incontinence frequency and severity, and improved quality of life among older women, according to a study published in JAMA Internal Medicine. “Urinary incontinence guidelines recommend behavioral interventions as first-line treatment using individualized approaches,” Ananias C. Diokno, MD, from the department of urology at Beaumont Hospital, Michigan, and colleagues wrote. “A one-time, group-administered behavioral treatment could enhance access to behavioral treatment.” Read more.
Source: Helio, September 5, 2018
Mirabegron is a safe and effective treatment for overactive bladder (OAB) in older patients, a researcher reported at the International Continence Society’s 2018 annual meeting. Adrian Wagg, MB, BS, of the University of Alberta in Edmonton, presented findings from a 12-week phase 4 prospective, randomized, placebo-controlled trial that enrolled 888 patients older than 65 years who had OAB symptoms for 3 months or more. The mean age of the patients was about 72 years. The proportion of patients older than 75 years was 28% among mirabegron and placebo recipients. Read more.
Source: Renal and Urology News, August 31, 2018
Most men who experience transient stress urinary incontinence (SUI) following holmium laser enucleation of the prostate (HoLEP) recover full bladder control within the first 6 weeks after the procedure, according to study findings presented at the International Continence Society’s 2018 annual meeting. In addition, the study identified prostate size larger than 100 g and catheter dependency prior to HoLEP, and longer operative time as risk factors for transient SUI. A retrospective review of 515 patients who underwent HoLEP showed that 53 (10.3%) experienced transient SUI, Jenny Guo, BS, and colleagues at Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia, reported. Transient SUI resolved within the first 6 weeks post-operatively in 47 (88.6%) of these patients and within 6 week to 3 months in 6 patients (11.3%). Read more.
Source: Renal and Urology News, August 30, 2018
Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, exhibits data highlighting comparable safety and efficacy of its INNOVO® therapy, an externally worn electrical muscle stimulation device for the treatment of stress urinary incontinence, with greatly reduced risk of infection and improved user tolerability over existing intravaginal probe devices1. Presented as a poster at the 48th Annual Meeting of the International Continence Society, the data was the result of an FDA designed clinical trial, with patients whose condition had not improved using pelvic floor muscle training. Supporting Atlantic Therapeutics’ FDA approval via the De Novo route for INNOVO®. Designed for at home use and worn as a close-fitting pair of shorts, INNOVO® was compared with an existing FDA approved intravaginal stimulation product as control. Read more.
Source: PRNewswire, August 28, 2018
TARIS, a biopharmaceutical company developing transformational therapies to treat people with debilitating urological disorders, today announced positive preliminary safety and efficacy data from its clinical study of TAR-302 for the treatment of patients with idiopathic overactive bladder (OAB) refractory to oral therapy. Subjects in the Phase 1b study received a single TAR-302 system, which provides continuous local dosing of the approved antimuscarinic agent trospium into the bladder. Subjects who were experiencing an average of more than five daily urge incontinence episodes demonstrated a reduction in mean daily episodes of 75% following dosing for 42 days (p=0.0049). Based on the unmet need in this disease state and the efficacy demonstrated in this study on established endpoints, TARIS plans to rapidly advance this program into later stage trials. “The results of this study suggest TAR-302 may come to represent an innovative new approach to treating overactive bladder,” said Michael J. Kennelly, M.D., FACS, Professor of Urology at Carolinas Medical Center, Medical Director of the Charlotte Continence Center and Women’s Center of Pelvic Heath, and Principal Investigator of the TAR-302 clinical studies. “There is a substantial need for alternative options in the management of OAB when patients fail oral therapies. The compelling efficacy observed to date with TAR-302, in the absence of side-effects, represents a potentially significant advance in the development of improved therapies for these patients.” Read more.
Source: PRNewswire, August 28, 2018