Erasing Brow Furrow:
Allergan's BOTOX® Cosmetic Receives Approval by the FDA for the Treatment of Glabellar Lines (Brow Furrow)
Photo below: Before and After BOTOX® COSMETIC Treatment
Photos courtesy of Allergan
Click here to watch video news release about Botox®, reported by Franklin Feinberg.
DALLAS, Apr 16, 2002/ FW/ --- Allergan, Inc. (NYSE: AGN) today announced that the U.S. Food and Drug
Administration (FDA) has granted approval to BOTOX® Cosmetic (botulinum toxin
type A) for the temporary improvement in the appearance of moderate to severe
glabellar lines (brow furrow) in adult men and women 65 or younger.
The approval specifically applies to the vertical lines between the eyebrows. In conjunction
with this approval, BOTOX® will be marketed for this use under the name BOTOX®
COSMETIC with dosing specific to treat frown lines.
Most brow furrow lines are formed by excessive contraction of the two major
muscles in the forehead, the corrugator and procerus muscles. BOTOX® COSMETIC
works to relax these muscles by blocking nerve impulses that trigger
wrinkle-causing muscle contractions, creating a smoothed and improved appearance
between the brow.
Administered in a few tiny injections of purified protein,
this minimally invasive treatment is simple and quick and delivers dramatic
results with minimal discomfort. Results can be seen within 24-48 hours and the
effect lasts up to four months.
In clinical trials of BOTOX® COSMETIC, the most frequently reported adverse
events (BOTOX® COSMETIC: N = 405; placebo: N = 132) were headache (13.3% of
those treated with BOTOX® COSMETIC versus 17.7% of those treated with placebo),
respiratory infection (3.5% vs. 3.8% with placebo), blepharoptosis or temporary
eyelid droop (3.2% vs. 0% with placebo), nausea (3.0% vs. 2.3% with placebo) and
flu syndrome (2.0% vs. 1.5% with placebo).
Less frequently occurring adverse
reactions included pain in the face, erythema (redness) at the injection site
and muscle weakness. These events are thought to be associated with the
injection and occurred within the first week. BOTOX® Cosmetic should not be used
in the presence of infection at the proposed injection sites(s).
Allergan's BOTOX® product is the only one of its type with over 10 years of
successful clinical experience in therapeutic conditions. Neurological disorders
for which BOTOX® therapy is currently approved in the U.S. include treatment of
strabismus (crossed eyes), blepharospasm (uncontrollable blinking) and head
position and neck pain associated with cervical dystonia (a movement disorder
characterized by involuntary muscle contractions).
BOTOX® therapy is approved in 70 countries for a broad range of conditions,
and is currently being investigated in the U.S. for the treatment of many
different medical conditions including hyperhidrosis (excessive sweating),
post-stroke spasticity, back spasm and headache.
Full prescribing information for both BOTOX® and BOTOX® COSMETIC is available
at www.botox.com
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