* 33 million Americans suffer from overactive bladder
* Analysts forecast more than $200 mln in additional sales
* Allergan sees 2012 Botox sales of $1.76 bln to $1.8 bln
Jan 18 The popular Botox wrinkle treatment made
by Allergan Inc has been approved to treat adults with
overactive bladder who cannot tolerate or failed to be helped by
other drugs for the condition, the U.S. Food and Drug
Administration said on Friday.
Botox injected into the bladder muscle causes the bladder to
relax, increasing its storage capacity and reducing episodes of
urinary incontinence, or leakage.
"Clinical studies have demonstrated Botox's ability to
significantly reduce the frequency of urinary incontinence,"
Hylton Joffe, director of the FDA's Division of Reproductive and
Urologic Products, said in a statement. "Today's approval
provides an important additional treatment option for patients
with overactive bladder, a condition that affects an estimated
33 million men and women in the United States."
Botox had previously been approved for other non-cosmetic
uses, such as migraine headaches, severe underarm sweating and
loss of bladder control due to nerve damage.
Allergan, which has yet to report full year financial
results, said it expects 2012 Botox sales of $1.76 billion to
$1.8 billion. Analysts have said that approval for overactive
bladder could add more than $200 million a year to Botox sales.
The treatment can be repeated when the effect wears off, but
with a gap of at least 12 weeks between treatments, the FDA
About 3.2 million Americans suffering from overactive
bladder take oral medications from a class of drugs called
anticholinergics, such as Pfizer Inc's Detrol. The Botox
approval is for those who are not helped by, or cannot take,
those drugs, the FDA said.
Overactive bladder is a condition in which the bladder
squeezes too often or squeezes without warning. Symptoms include
leaking urine, feeling a sudden and urgent need to urinate, and
Common side effects for Botox injected into the bladder
reported during clinical trials included urinary tract
infections, painful urination, and incomplete emptying of the
bladder, or urinary retention.
People being treated for overactive bladder with Botox
should not have a urinary tract infection and should take
antibiotics before, during, and for a few days after Botox
treatment to lower the chance of developing an infection from
the procedure, the FDA said.