Tuesday, March 3, 2009

Pfizer's New Bladder Drug - Toviaz

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. 8Pfizer 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

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