Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
Sacral Neuromodulation, Botulinum Show Equal Efficacy
In patients with refractory urgency urinary incontinence (UUI), sacral neuromodulation (InterStim) and onabotulinumtoxinA (Botox) produce similar reductions in mean daily UUI episodes, according to 24-month follow-up data on patients treated in a randomized trial. Investigators in the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation versus BoTulinum Toxin Assessment) trial in 2016 reported that botulinum toxin at 6 months of treatment resulted in a “small daily improvement in UUI episodes” that was statistically significant (JAMA 2016; 316:1366–74). Now, in long-term follow-up data on ROSETTA, NIH investigators reported at the International Continence Society annual meeting in Florence, Italy that the two treatments provide similar reductions in mean daily UUI episodes at 24 months. However, botulinum toxin treatment was more likely to provide complete resolution of episodes 6 months after treatment, and it was associated with higher patient satisfaction and treatment endorsement ratings over the 24 months, reported first author Christopher J. Chermansky, MD, assistant professor of urology at the University of Pittsburgh School of Medicine. Read more.
Source: Urology Times, November 14, 2017
New Surgery for Prostate Cancer Can Cut the Chance of Incontinence
Up to a quarter of prostate cancer patients suffer temporary or permanent incontinence after surgery. Steve Gregory, 60, a retired IT director from Hampshire, underwent a procedure said to reduce this risk. ANGELA EPSTEIN reports.
As someone who has always been fit, I never thought that I’d develop prostate cancer. But for about a year before my diagnosis, I was waking up twice a night to go to the loo. In February 2016 I finally saw my GP, mainly because my close friend, Nick, had been diagnosed with the disease, so it was on my mind. Read more.
Source: DailyMail.com, November 13, 2017
Innovus Pharma Announces Agreement with ACON Laboratories, Inc.
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 it has entered into an agreement with ACON Laboratories, Inc. (“ACON Labs”). ACON Labs is a San Diego-based diagnostic product manufacturer who will supply Innovus Pharma with its U.S. Food and Drug Administration’s (“FDA”) cleared Urinary Tract Infection (“UTI”) test strips. Innovus Pharma will offer the UTI test strips, which provide results in 2-minutes, to its customers who buy its UriVarx™ product. UriVarx™ is clinically tested in patients with overactive bladder (“OAB”) and urinary incontinence (“UI”). Innovus Pharma is expected to launch the UTI strips under its UriVarx™ brand in Q1 2018. Read more.
Source: Market Insider, November 9, 2017
Allergan Partners with Urine Incontinence Treatment Company
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
Crohn’s and Colitis Canada Wants Businesses to Open Their Washrooms to Those In Need
Crohn’s and Colitis Canada is taking aim at a serious hurdle many Canadians with Crohn’s disease or ulcerative colitis face – accessing washrooms on the go. November is Crohn’s and Colitis Awareness Month, and the national charity is advocating that public washroom access is a right, not a privilege, and for the Canadians living with these chronic diseases, it’s a critical need. Crohn’s and colitis are debilitating, yet often invisible, autoimmune diseases. They cause the body to attack healthy tissue, leading to the inflammation of all or part of the digestive tract. Symptoms include diarrhea, internal bleeding, and abdominal pain, and result in the frequent and urgent need to use the washroom, in some cases over 20 times a day. Read more.
Source: CNW, November 1, 2017
November Marks National Bladder Health Month
November is National Bladder Health Month and, for a second year, the Urology Care Foundation, American Urological Association (AUA) and the Bladder Health Alliance – a coalition of groups representing physicians, patients and veterans – have teamed up to support Bladder Health Month. Designed to raise awareness about bladder conditions, encourage individuals to talk with their healthcare providers about the symptoms they are experiencing and to generate support for those affected by bladder health issues, this month-long awareness campaign was developed to increase an individual’s focus on “Getting the Facts, Getting Diagnosed and Taking Control” of their Bladder Health. Read more.
Source: Markets Insider, November 1, 2017