product approval

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

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

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

elderly underactive bladder symptoms needed to be reported

Drug Tied to Dementia Risk Overprescribed to Seniors: Study

A drug linked to a raised risk of dementia is taken by millions of older Americans who have an overactive bladder, researchers say.  More than one-quarter of patients with the urinary problem had been prescribed the drug oxybutynin (Ditropan), an international team of investigators found.  Yet, “oxybutynin is a particularly poor drug for overactive bladder in elderly patients,” said study lead author Dr. Daniel Pucheril, a urologist at Henry Ford Hospital in Detroit.  Prior studies have linked the drug to thinking problems and increased risk of dementia in older people, possibly because of the way it affects brain chemicals, he said.  “It’s a great and effective drug for younger patients, but is a risky drug for older patients,” Pucheril said. It boosts dementia risk even when not taken indefinitely, he said.  Alternatives exist but they’re more expensive and may not be covered by insurance, at least initially, the study authors explained.  Read more.

Source: HealthDay News, March 30, 2017

drugs for overactive bladder (OAB)

Innovus Pharma Launches its Clinically Proven UriVarx™ Product for Bladder Health in the United States

Innovus Pharmaceuticals, Inc. (“Innovus Pharma”) (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 the launch of UriVarx™ in the U.S. UriVarx™ is clinically proven to reduce urinary urgency, accidents and both day and night frequency in Overactive Bladder (“OAB”) and Urinary Incontinence (“UI”) patients.  Read more.

Source: BusinessWire, December 1, 2016