New Cosmetic Indication Underscores
(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.