medical research

RDD Pharma Awarded CDMRP Grant for Clinical Drug for SCI Patients

RDD Pharma, a leader in developing treatments for anorectal disorders, announced today the Department of Defense office of the Congressionally Directed Medical Research Programs (CDMRP) has funded the Spinal Cord Injury Research Program (SCIRP) Translational Research Award – Clinical Trial application.  The grant of $1.28M will enable initial U.S. clinical development of RDD-0315 for fecal incontinence in spinal cord injury patients including preparations for and conducting of a Phase 1 study in healthy volunteers to assess acute tolerance and PK.  “We are pleased the CDMRP recognized the clinically significant benefit that RDD-0315 may offer spinal cord injury patients,” stated Jason Laufer, Chief Executive Officer, RDD Pharma.  “We can now move forward more aggressively in the U.S. to develop RDD-0315 which has the potential to positively impact the health, well-being and quality of life in this patient population.”  Read more.

Source: PRNewswire, September 14, 2017

PTNS Urgent PC Cogentix

Cogentix Announces Cahaba Extends Urgent PC Maintenance Coverage

Cogentix Medical, Inc. (NASDAQ: CGNT), a global medical device company focused on providing the Urology, Uro/Gyn and Gynecology markets with innovative and proprietary products, today announced that Cahaba Government Benefit Administrators, LLC has modified their policy for Percutaneous Tibial Nerve Stimulation (PTNS) delivered via Cogentix Medical’s Urgent® PC Neuromodulation System to allow for ongoing maintenance treatments for an indefinite period of time.   “This policy update further reinforces the medical necessity of Urgent PC as a long-term solution for patients suffering with overactive bladder symptoms,” said Darin Hammers, President and CEO. “Additionally, the policy change to indefinite coverage allows the patient and physician to decide whether to continue ongoing treatment with Urgent PC to sustain their symptomatic improvements.”  Read more.

Source: PRNewswire, September 13, 2017

Florence Italy ICS 2017

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

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

drugs for overactive bladder (OAB)

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

business buildings

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

microbiologist at laboratory work

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

depression elderly nursing home

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

bladder retraining timed intervals

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

 

surgeons perform pelvic organ prolapse surgery

Women Damaged by Surgical Mesh to Treat Incontinence Are Furious at Report

Women damaged by surgical mesh used to treat post-childbirth incontinence have reacted with fury to a Government report investigating the problem.  At least 7,800 women say they’ve suffered lacerations and nerve damage because the mesh has broken into tiny fragments.  The report, which is unpublished but has been seen by Good Health, is the result of a three-year investigation by NHS England. It confirms that many more women have complained of injuries than previously suggested and calls for a helpline to support victims.  But it did not look at the safety of the mesh and rejects calls for a ban. Instead, it says hospitals should ensure that surgeons be trained to implant it; at the moment any gynaecologist can perform the procedure. Read more.

Source: Daily Mail, July 25, 2017