ALLERGAN’S BOTOX® COSMETIC RECEIVES
APPROVAL
BY THE FDA FOR THE TREATMENT OF GLABELLAR LINES
(BROW FURROW)
New Cosmetic Indication Underscores
Product’s Versatility
(Irvine, CA, April 15, 2002) – Allergan, Inc. (NYSE: AGN)
announced today 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 in adult men and women 65 years of age 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.
"The FDA’s approval is an important corporate accomplishment.
Our successful clinical work shows that BOTOX® COSMETIC is safe
and effective for this aesthetic use," commented Lester J.
Kaplan, PhD, Allergan’s President of Research and Development
and Global BOTOX®. "Along with the previous approvals in
the U.S. for BOTOX® in the treatment of certain neurological
disorders, this new indication firmly establishes the versatility
of the product."
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).
Most brow furrow lines are formed by excessive contraction of the
2 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 brows. 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 as early as 24 to 48 hours
and the effect lasts up to 4 months.
"BOTOX® COSMETIC treatments are one of the few procedures
we do that result in high patient satisfaction within a short period
of time. In fact, the American Society for Aesthetic Plastic Surgery
(ASAPS) 2001 Statistics on Cosmetic Surgery listed BOTOX® COSMETIC
injections as the fastest growing cosmetic treatment performed by
surgeons in the U.S. BOTOX® COSMETIC treatments have increased
46% since 2000 and were rated #1 among the 8.5 million surgical
and non-surgical cosmetic procedures performed in 2001," said
Dr. Roberta D. Sengelmann, MD, Assistant Professor, Dermatology
and Otolaryngology at Washington University in St. Louis. "I
have treated hundreds of patients with BOTOX® COSMETIC and the
response from my patients has been overwhelmingly positive. Patients
come to me saying they are often perceived by their friends, families,
and colleagues as angry, stressed, or worried due to the unwanted
expressions from the lines between the brows. Within a few days
after a BOTOX® COSMETIC treatment, patients look more refreshed
and natural."
Jennifer J. Luner, a 49-year-old business consultant, says that
before she tried a BOTOX® COSMETIC treatment, her friends and
colleagues often thought she was upset or worried, even if she wasn’t.
"After the treatment, my friends told me I looked so much more
refreshed and approachable."
The 12-month, repeated-treatment study consisted of a 4-month, double-blind,
placebo-controlled period that evaluated 537 patients (BOTOX®
COSMETIC: n = 405; placebo: n = 132) for efficacy, followed by an
8-month, open-label period evaluating safety with 373 patients continuing
from the first period. In the first period, the maximum response
rate occurred at day 30, with investigators rating 80.2% of the
subjects treated with BOTOX® COSMETIC versus 3.0% of those subjects
treated with placebo as responders to therapy as assessed by reduction
in the severity of glabellar lines at maximum frown. A significant
improvement in brow furrow appearance as rated by the subject’s
self-assessment also occurred in 89.4% of those treated with BOTOX®
COSMETIC versus 6.8% of the placebo group.
In clinical trials of BOTOX® COSMETIC, the most frequently reported
adverse events were headache (13.3% of those treated with BOTOX®
COSMETIC vs 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 site(s).
Allergan’s BOTOX® product is the only one of its type
with over 10 years of successful clinical experience in therapeutic
conditions. In 1989, BOTOX® therapy was approved in the U.S.
for the treatment of strabismus and blepharospasm and, in December
2000, for the treatment of abnormal head position and neck pain
associated with cervical dystonia. BOTOX® COSMETIC was previously
approved in Canada in April 2001 for the treatment of glabellar
lines.
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.
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