drugs for overactive bladder (OAB)

First Big Test Approaches for Urovant

Investors who backed Urovant’s $140m flotation last September will soon find out whether the money was well spent. Before the end of March the company will release topline pivotal data on the overactive bladder project vibegron, a β3-adrenergic receptor agonist licensed from Merck & Co, and a positive result should allow regulatory filings to follow.  It seems likely that the trial will hit: Merck successfully conducted a large phase IIb study of vibegron a few years ago, and a similar compound is already on the market in the shape of Myrbetriq, which has been sold by Astellas since 2011. This well-established product has only four years of US patent life left, so if Urovant has any chance of building vibegron into a similarly large product it needs to prove that its contender is both safer and more effective.   Read more.

Source: Evaluate, March 12, 2019

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

product approval introduction

FDA Approves Myrbetriq Combo Treatment for Overactive Bladder

The Food and Drug Administration (FDA) has approved Myrbetriq (mirabegron extended-release tablets; Astellas) in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. In clinical trials, the combination of Myrbetriq + solifenacin succinate was associated with greater improvements in the number of incontinence episodes per 24 hours (primary endpoint), the number of micturitions per 24 hours (primary endpoint), and the volume voided per micturition (secondary endpoint) compared to placebo or to individual active components. Long-term data also demonstrated that the effects of combination treatment were maintained throughout a 1-year treatment period. Read more.

Source: MPR, April 30, 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

drugs for overactive bladder (OAB)

Urinary Incontinence: What Pharmacists Should Know

Urinary incontinence (UI), the involuntary leakage of urine, is a frequent and problematic chronic condition for many patients. An estimated 10 to 30% of men and women are affected nationally, though this may be underestimated due to underdiagnoses and undertreatment.1-3 Often, patients who suffer with UI symptoms will develop poor self-rated health, depression, and mobility disability.4,5 This comorbid disease state also presents a substantial financial burden; data from 2014 found that in the United States alone, an estimated $65.9 billion in direct and indirect costs were spent for UI treatment.3  Read more.

Source: Drug Topics, January 23, 2018

sleep woman nocturia

Sleep Quality Improves with Help of Incontinence Drug

A drug used to curtail episodes of urinary incontinence in women also improves quality of sleep, a researcher at the Stanford University School of Medicine reports.  People who experience urinary incontinence, especially at night, often have trouble maintaining normal sleep cycles. Now, the Stanford researcher sees promise in using one drug to help remedy both problems.  “Two of the biggest quality-of-life factors for older women are poor sleep quality and incontinence, and the older you get, the more prevalent both conditions are, and they do seem to be correlated,” said Leslee Subak, MD, professor and chair of obstetrics and gynecology. “And so, if we can find a drug to treat one and effectively decrease the other too, that could be big for improving quality of life.”  Read more.

Source: Stanford Medicine News Center, January 11, 2018

You may also with to read:  Incontinence Drug May Help Sleep Dysfunction in Older Women

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

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

operating room surgery

Majority of Incontinence Treatments Deliver Poor Results

Surgery is the most reliable method of treatment for incontinence – curing the condition in just over eight in ten cases; other types of treatment, meanwhile, do not deliver the same kind of success. These are the findings of a comprehensive systematic overview of cure rates for the treatment of incontinence around the world during the last ten years. “Unfortunately we are not actually curing the condition in that many cases. Surgery aside, the results delivered are poor. And the problems are only going to get worse in the future because the population, as we know, is aging,” says Ian Milsom, Professor of Gynecology and Obstetrics at the Sahlgrenska Academy and Head of the Gothenburg Continence Research Center (GCRC). Read more.

Source: Science Daily, April 4, 2017