drugs for overactive bladder (OAB)

Kyorin Receives Approval from Japan’s Ministry of Health, Labour and Welfare for Vibegron for Overactive Bladder

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

elderly underactive bladder symptoms needed to be reported

Mirabegron Safe, Effective for Overactive Bladder in the Elderly

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

bladder retraining timed intervals

TARIS Announces Positive Topline Data for TAR-302 in Patients with Idiopathic Overactive Bladder

 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

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

hurrying with overactive bladder

Innovus Pharma Announces the Publication of a Successful Clinical Trial in Overactive Bladder and Urine Incontinence Patients for its UriVarx® Product

Innovus Pharmaceuticals, Inc. (“Innovus Pharma” or the “Company”) (OTCQB Venture Market: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women’s health and respiratory diseases, today announced that the human clinical trial for the patented formulation in its product UriVarx® product for bladder health was published in the peer reviewed journal, BMC Complementary and Alternative Medicine (Schoendorfer et al. BMC Complementary and Alternative Medicine (2018) 18:42). The study was conducted by the team of Dr. Niikee Schoendorfer in Australia in collaboration with the Company’s UriVarx® licensing partner Seipel Group, Ltd. The outcome of this study demonstrated both statistical significance and clinical relevance in reducing symptoms of Overactive Bladder (“OAB”), urinary frequency and/or urgency and incontinence. Read more.

Source: Digital Journal, February 7, 2018

product approval

Axonics® Receives IDE Clearance from US FDA to Conduct Pivotal Study

Axonics Modulation Technologies, Inc., developer of the first rechargeable sacral neuromodulation (r-SNM™) system for the treatment of overactive bladder (OAB) and bowel dysfunction, today announced the U.S. Food & Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) in accordance with 21 CFR 812 regulations allowing Axonics to conduct a pivotal study designed to gain FDA approval in the United States.  “During 2017, as part of the IDE process, the FDA conducted a significant review of our product. A major focus of the technical review was the long-term safety of our implant. The fact that we were able to support our anticipated 15-year full system life-in-the-body claim based on our robust design and development processes, risk analysis and extensive validation testing is testament to the high-quality work of our team,” said Raymond W. Cohen, Chief Executive Officer of Axonics. “Given the demand in the U.S. market for SNM therapy, gaining FDA approval is our main focus. To that end, we fully intend to execute this well-designed pivotal study with velocity and in the best interests of patients.” Read more.

Source: Pharmaweb, November 7, 2017

Florence Italy ICS 2017

Positive Results for the Axonics® RELAX-OAB Clinical Presented at ICS

Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and bowel dysfunction, today announced the presentation of positive results from its prospective, multicenter clinical study at the 2017 International Continence Society (ICS) Congress in Florence, Italy.  The presentation, entitled “A prospective multicenter clinical study evaluating a miniaturized rechargeable sacral neuromodulation system for the safe and effective treatment of overactive bladder (RELAX-OAB study),” was delivered by Bertil F.M. Blok, M.D., PhD, Dept. of Urology, Erasmus University Medical Centre, Rotterdam, Netherlands.  Read more.

Source: Business Wire, September 13, 2017

sacral nerve stimulation

Medtronic Touts 5-Year Data on InterStim Neuromod Device for OAB

Medtronic today touted 5-year results from the InSite study of its InterStim neuromodulation treatment for overactive bladder syndrome.  InterStim is designed to stimulate the sacral nerve to treat OAB, meaning urinary urge incontinence and/or urgency-frequency. The InSite study enrolled 340 patients, of which 272 were implanted with an InterStim device, comparing treatment with the device with standard drug therapy. The primary safety endpoint was to “demonstrate that the upper bound of the 95% CI for the cumulative five-year rate of adverse events related to the tined lead that require surgery is less than 33%” at 5 years, according to ClinicalTrials.gov. The primary efficacy endpoint was superior improvement in OAB symptoms at 6 months. Read more.

Source: MassDevice Today, July 17, 2017

business buildings

Unique Method Trains Brain of Incontinence Patients

Czech experts have developed a unique method to help patients with urinary incontinence by teaching their brain to ignore false signals it receives from their hyperactive bladder, daily Hospodarske noviny (HN) wrote on Wednesday.  The breakthrough method, together with a special device it uses, will facilitate the treatment of incontinence, the experts from Charles University’s 2nd Medical Faculty say.  The device will be produced by the Tesla Medical company, which has gained 20 million crowns from small investors for this purpose, HN writes.  Read more.

Source: Prague Daily Monitor, July 12, 2017.