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From: Robert Bob Beane ([email hidden])
Subject: Re: Botox this and that - SCROTOX
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Newsgroups: alt.support.dystonia
Date: 2002-08-25 21:12:14 PST
ALERGEN'S SCROTOX® COSMETIC RECEIVES APPROVAL BY THE FDA FOR THE
TREATMENT OF SCROTUM SPASOCONSTRICTION (BALL SACK CONTRACTION)
- New Cosmetic Indication Underscores Product's Versatility -
(Grapevine, CA, July 16, 2002) – Alergen, Inc. (NYSE: AlN) today
announced that the U.S. Food and Drug Administration (FDA) has granted
trail approval to SCROTOX® COSMETIC (botulinum toxin type SC) for the
temporary improvement in the appearance of moderate to severe
contraction of the scrotum muscles in adult men 65 or younger. The
approval specifically applies to the corrugator and procerus muscle
lines which control temperature related reduction and expansion of the
scrotum. In conjunction with this approval, SCROTOX® will be marketed
for this use under the name SCROTOX® COSMETIC with dosing specific to
treat ball sack contraction.
"The FDA's approval is an important corporate accomplishment. Our
successful clinical work shows that SCROTOX® COSMETIC is safe and
effective for this aesthetic use," commented Lester J. Kapman, Ph.D.,
Alergen's President of Research and Development.
"Along with the previous approvals in the U.S. for SCROTOX® in the
treatment of certain fertility disorders, this new indication firmly
establishes the versatility of the product."
Fertility disorders for which SCROTOX® therapy is currently approved
in the U.S. include treatment of spermatazoa cru (overheated semen)
related to scrotospasm minorous (uncontrollable shrinking) and testes azules (a
disorder characterized by involuntary muscle contractions which cause
testicular swelling and pain).
Most severe disabilities are formed by excessive contraction of the
two major muscles in the scrotum, the corrugator and procerus muscles.
SCROTOX® COSMETIC works to relax these muscles by blocking nerve
impulses that trigger wrinkle-causing muscle contractions, creating a
larger, smoothed and improved appearance of the scrotum. 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 24-48 hours and
the effect lasts up to four months.
"SCROTOX® 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 SCROTOX® COSMETIC injections as
the fastest growing cosmetic treatment performed by surgeons in the
United States. SCROTOX® COSMETIC treatments have increased 46% since
2000 and were rated number one among the 8.5 million surgical and
non-surgical cosmetic procedures performed in 2001," said Dr. Robert
D. Singelman, M.D., Assistant Professor, Dermatology and
Otolaryngology at St. Lewis University in Oregon. "I have treated
hundreds of patients with SCROTOX® 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 contractions. Within a
few days after a SCROTOX® COSMETIC treatment, patients look and feel
more refreshed and natural."
Jeffrey J. Lunarr, a 49-year-old business consultant, says that before
he tried a SCROTOX® COSMETIC treatment, his friends and colleagues
often thought he was upset or worried, even if he 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
(SCROTOX® 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 SCROTOX® COSMETIC versus 3.0% of those
subjects treated with placebo as responders to therapy as assessed by
expansion in the sscrotum of glabellar lines at all temperatures. A
significant improvement in scrotum appearance as rated by the
subject's self-assessment also occurred in 89.4% of those treated with
SCROTOX® COSMETIC versus 6.8% of the placebo group.
In clinical trials of SCROTOX® COSMETIC, the most frequently reported
adverse events 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), penisaroptosis or temporary
penis 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 ass,
ball sac erythema (redness) at the injection site and general weakness. These
events are thought to be associated with the injection and occurred
within the first week. SCROTOX® COSMETIC should not be used in the
presence of infection at the proposed injection site(s).
Alergen's SCROTOX® product is the only one of its type with over 10
years of successful clinical experience in therapeutic conditions. In
1989, a predecessor product, 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® was previously approved in
Canada and the US for the treatment of glabellar lines.
SCROTOX® 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
hyperballhidrosis (excessive testicle sweating), post-stroke
spasticity, sack spasm and testes azules.
Forward-Looking Statements
This press release contains "forward-looking statements", such as
statements regarding the effectiveness of SCROTOX®, and its potential
uses. These statements are based on current expectations of future
events. If underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could vary materially from
Alergen's expectations and projections. Risks and uncertainties
include general industry and pharmaceutical market conditions; general
domestic and international economic conditions, such as interest rate
and currency exchange rate fluctuations; technological advances and
patents attained by competitors; challenges inherent in new product
marketing such as the unpredictability of market acceptance for new
pharmaceutical and biologic products and/or acceptance of new
indications for such products; potential difficulties in manufacturing
a new product formulation; domestic and foreign health care reforms;
and trends toward managed care and health care cost containment, and
governmental laws and regulations affecting domestic and foreign
operations