Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
GTx Announces Positive Results from Enobosarm Phase 2 Clinical Trial
GTx, Inc. (Nasdaq: GTXI) today announced top-line clinical trial results demonstrating that a daily dose of enobosarm 3 mg (GTx-024) substantially improved stress urinary incontinence (SUI) in women, as well as related quality of life measurements. In this open-label clinical trial, all 17 patients completing 12 weeks of treatment saw a clinically significant reduction (50 percent or greater) in stress leaks per day, compared to baseline. Mean stress leaks decreased by 83 percent from baseline over 12 weeks, and the reductions in daily stress leaks following completion of treatment have been sustained as patients are being followed for up to 7 months post-treatment to assess the durability of treatment effect. No patient has relapsed to her baseline levels. These results were presented at the International Continence Society (ICS) Annual Meeting currently being held in Florence, Italy from September 12-15, 2017. Read more.
Source: Business Wire, September 13, 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
U.S. FDA Accepts for Review Astellas sNDA for Mirabegron
Astellas Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The anticipated Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 28, 2018. In the United States, mirabegron and solifenacin succinate are marketed as Myrbetriq® and VESIcare®, respectively. Each is approved by the FDA as a monotherapy for the treatment of OAB with symptoms of urge urinary continence, urgency and urinary frequency. Read more.
Source: Gurufocus.com, September 12, 2017
State-backed Fund Boosts Monroe Company’s Elitone Medical Device
A Connecticut venture fund is backing a Monroe startup that is seeking Food and Drug Administration approval of a device to help alleviate a urological disorder affecting millions of women. In April, Newtown residents Gloria and Eric Kolb won U.S. patent protection on Monroe-based Elidah’s Elitone device to help women with stress urinary incontinence, with the Elitone device emitting mild electric impulses to stimulate and strengthen pelvic muscles. Women diagnosed with the condition can suffer urinary leakage during physical exertion or while coughing or sneezing. To date, physicians have recommended solutions ranging from exercises to surgical implants called pelvic meshes, with thousands of lawsuits having been filed against three manufacturers of the devices the past few years after women suffered adverse reactions. Read more.
Source: ctpost, August 17, 2017
Lab-engineered Tissue Is Creating New Digestive Tract Treatments
Wake Forest Baptist Medical Center have reported success with lab-engineered tissue replacements to treat digestive system diseases. The research team demonstrated the effectiveness of growing anal sphincters in a lab to treat an animal model for fecal incontinence. The success comes after the researchers reported success in implanting human-engineered intestines in rodents. “Results from both projects are promising and exciting,” said Khalil N. Bitar, senior researcher on both projects, in a press release. “Our goal is to use a patient’s own cells to engineer replacement tissue in the lab for devastating conditions that affect the digestive system.” Read more.
Source: Medical Design & Outsourcing, August 10, 2017
Common Drugs Hike Death Risks By 31%
A class of medications commonly prescribed to seniors for conditions such as urinary incontinence might increase the risk of mortality among nursing home residents with depression, a recently published study shows. Anticholinergic drugs have previously been found to increase emergency department and hospital visits for seniors, but little research had been done on the link between the drugs’ use and mortality among nursing home residents, researchers from the University of Houston said. Their study, published in June in Drugs & Aging, used nearly 45,000 residents’ Minimum Data Set information. The residents included in the study were prescribed “clinically significant” anticholinergic medications and had previously been diagnosed with depression. Read more.
Source: McKnight’s, August 9, 2017
Prostate Operation That’s Done Via Your WRIST Can Cut Threat of Incontinence
THE PATIENT. About eight years ago, I started needing the loo frequently at night. I put up with it at first, but it gradually got worse — at one point I needed to go five or six times a night. My GP told me to avoid alcohol and caffeine as these irritate the bladder, but this didn’t make a great difference and my symptoms continued to worsen. By last year, I was getting up for the loo in the night so often it left me feeling tired during the day. My GP suspected I had an enlarged prostate so referred me to a urologist. A few weeks later, I underwent various tests, including one where a machine measures the speed of your urine flow. Read more.
Source: Daily Mail, August 7, 2017