Toviaz New Treatment for Urinary Incontinence / Overactive Bladder

The urinary bladder is an organ that collects urine from the ureters. Urine is excreted by the kidneys prior to disposal by urination through the uretha. 3 The pelvic floor muscles contracts to store urine in the bladder. Nerve signals from the bladder inform the brain when it is full. At an appropriate place and time, as a response the pelvic floor muscle becomes relaxed allowing the bladder to contract, subsequently urine is passed through the urethra and out of the body through the male or female anatomical structure. Urinary incontinence is a loss of bladder control or leakage of urine, result of physiologic or pathologic (disease) occurrence. 1 Accidental leakage of urine is less common in girls than in boys. 5 In the United States estimated one in six people have an overactive bladder (OAB). 2 Urinary incontinence disrupts daily activities including social, sexual and workplace. 9 Besides frequent trips to the bathroom during the time of normal sleep and daily activities. 10 "Overactive bladder may also lead to other health problems, such as falls, and fractures, urinary tract infections, and skin disorders, sleep problems and depression. 9

Cause of urinary incontinence except during infancy include: Alcohol, dehydration, over-hydration (drinking a lot of water), sides effects of medication, caffeine, related injury or illnesses, enlarged prostate, urinary traction infection, stress, constipation, high-impact sports, bladder cancer or bladder stones, obstruction along the urinary tract, obesity, age ("Up to 35% of the total population over the age 60 years is estimated to be incontinent, with women twice as likely as men to experience incontinence." 4) and other factors. 5 For women, causes related to an over active bladder include pregnancy, childbirth, menopause, and after hysterectomy. 5

Recommended diagnostic tests for over active bladder: Cystoscopy:("the doctor inserts a thin a tube with a tiny a camera in the urethra to see inside the urethra and bladder"), Urodynamics ("Various techniques measure pressure in the bladder and the flow of urine."), bladder stress test, ultrasound (Sound waves create images of the kidneys, ureters, bladder and urethra), and Urinalysis and urine culture (Testing a sample of urine for infection, urinary stones and other causes). 7

In October 2008, Food and Drug Administration approved Toviaz (fesoterodine fumarate) prescribed extended release tablets for the treatment of overactive bladder or urinary incontinence symptoms (Include strong urges to go frequently). Toviaz marketed and sold by Pfizer pharmaceuticals once daily medication. 8 Toviaz was developed by Schwarz Pharma (Zwickau, Germany 12). In 2006, Schwarz Pharma sold the rights of Toviaz to Pfizer for as much as $210 million. In June 2007, the drug became available for sale Europe after winning European marketing approval. 11

During clinical testing of Toviaz, significantly reduced the number of frequent urinary incontinence episodes over twenty-four hours. "The approval of Toviaz (by the FDA) is based on two large 12-week Phase Three clinical studies of 1,964 OAB patients." When participants of the studies were given Toviaz 8 mg, the affect of the medication was realized as soon as week two of treatment, eighty-eight percent medium reductions in urinary incontinence episodes. During clinical testing, those who had received four milligrams of Toviaz, nineteen percent experienced dry mouth and thirty-five percent experienced dry mouth when eight mg was taken. Less than one percent of those experiencing dry mouth discontinued the medication. Also, few number of constipation incidences occurred as the amount of medication increased. During three years Toviaz was under review, continued to confirm the adverse reaction of the medication. In 2009, Toviaz expected to be available for sale in the United States. 8

Pfizer Toviaz is not recommended for those who have stomach problems, glaucoma or trouble getting urine to pass. 8 The dosage of the medication will be available in four and eight milligrams, allow dosing flexibility depending on tolerance of side effects and patient response. 10 Prior approval of Toviaz required the FDA to inspect and approve the plant facility owned by Pfizer. "The medicine may have about $500 million in peak, annual sales and will compete with Pfizer's Detrol and Detrol LA, which work similarly and had combined sales of $1.2 billion last year (2007), analysts have said." 11

References:

1.) Incontinence - http://www.urologychannel.com/incontinence/index.shtml

2.) Pfizer's Toviaz (fesoterodine fumarate) receives FDA approval for the treatment of overactive bladder - http://www.news-medical.net/?id=42290

3.) Urinary Bladder - http://en.wikipedia.org/wiki/Urinary_bladder

4.) Uninary incontinence - http://en.wikipedia.org/wiki/Urinary_incontinence

5.) DISEASES AND CONDITIONS - Urinary incontinence - http://www.mayoclinic.com/health/urinary-incontinence/DS00404/DSECTION=causes

6.) Urinary Incontinence in Men - http://www.medicinenet.com/urinary_incontinence/article.htm

7.) Urinary Incontinence Women - http://kidney.niddk.nih.gov/kudiseases/pubs/uiwomen/

8.) Pfizer's Toviaz (fesoterodine fumarate) receives FDA approval for the treatment of overactive bladder - http://www.news-medical.net/?id=42290

9. International - Pfizer's bladder drug Toviaz receives US FDA nod - http://www.pharmabiz.com/article/detnews.asp?articleid=46779

10.) TOVIAZ (feoterodine Fumarate) Gets FDA Approval For Oberactive Bladder Treatment - http://www.medicalnewstoday.com/articles/127844.php

11.) Pfizer, UCB's Bladder Drug Toviaz Wins U.S. Approval (Update 3) - http://www.bloomberg.com/apps/news?pid=20601202&sid=atMRIWr3dpP0

12.) Moldova, Org - http://it.moldova.org/stiri/eng/162069/