Allergan, Inc. (NYSE: AGN) announced today that April 15, 2012 will mark the 10-year anniversary of the U.S. Food and Drug Administration’s (FDA) approval of BOTOX ® Cosmetic (onabotulinumtoxinA) to improve the look of moderate to severe frown lines between the eyebrows in patients age 18-65.
“When approved by the FDA in 2002, BOTOX ® Cosmetic changed the way that physicians could treat patients who were interested in improving the appearance of their vertical frown lines between the brows,” said David E.I. Pyott, Chairman of the Board, President and CEO, Allergan, Inc. “BOTOX ® Cosmetic has become the number-one neuromodulator in the United States and the number of patients considering talking to their doctor about treatment has more than quadrupled to 5.8 million since 2002. 1, 2”
BOTOX ® secured its first FDA approval more than 22 years ago as a treatment for two rare eye muscle disorders, making it the first product of its kind approved in the world. In 2002, the same formulation with dosing specific to frown lines was approved under the name BOTOX ® Cosmetic.
“The FDA approval of BOTOX ® Cosmetic enhanced the practice of plastic surgery by providing plastic surgeons with a new treatment option for patients seeking to reduce the appearance of vertical frown lines between the eyebrows,” said Malcolm Z. Roth, MD, president of the American Society of Plastic Surgeons.In the decade since BOTOX ® Cosmetic was approved, aesthetic specialty physicians – which include dermatologists, oculoplastic surgeons and facial plastic surgeons – have developed extensive experience in the art and science of administering BOTOX ® Cosmetic to yield predictable results for their patients. These physicians have performed approximately 11 million BOTOX ® Cosmetic treatment sessions since 2002 and have also contributed to the extensive clinical database demonstrating the safety and efficacy of the drug. “The approval of BOTOX ® Cosmetic in 2002 dramatically changed our ability to treat our patients by giving them an effective option to treat the appearance of moderate to severe vertical frown lines with a minimally invasive procedure,” said Susan Weinkle, MD, president of the American Society for Dermatologic Surgery. “BOTOX ® Cosmetic has become more accepted by the public, and this treatment has brought more patients into aesthetic practices to learn about other treatments available.” About BOTOX ® (onabotulinumtoxinA) BOTOX ® is a prescription-only medical product that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. BOTOX ® has a unique, protected molecular structure that stabilizes the core toxin in BOTOX ® from degradation. When injected at FDA-approved and labeled doses into a specific muscle or gland, BOTOX ® is expected to diffuse locally and produce a safe and effective result by producing a localized and temporary reduction in the overacting muscle or gland, usually lasting up to approximately three to ten months depending on the indication and on the individual patient. BOTOX ® was first approved by the FDA more than 22 years ago for the treatment of strabismus and blepharospasm, two eye muscle disorders, making it the first botulinum toxin type A product approved in the world. Since its first approval in 1989, BOTOX ® has been recognized by regulatory authorities worldwide as an effective treatment for 25 different indications in approximately 85 countries, benefiting millions of patients worldwide. In the United States, BOTOX ® is also approved to treat seven medical conditions, including the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults; symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough; for the treatment of increased muscle stiffness in elbow, wrist, and finger muscles in adult patients with upper limb spasticity; for the prophylactic treatment of headaches in adults with Chronic Migraine, a distinct and severe neurological disorder characterized by patients who have a history of migraine and suffer from headaches on 15 or more days per month with headaches lasting four hours a day or longer; and most recently, for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g. spinal cord injury (SCI), multiple sclerosis (MS)) in adults who have an inadequate response to or are intolerant of an anticholinergic medication. In addition to its therapeutic uses, the same formulation of BOTOX ® with dosing specific to moderate to severe glabellar lines was approved by the FDA in 2002 under the trade name BOTOX ® Cosmetic (onabotulinumtoxinA). BOTOX ® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines between the eyebrows) associated with corrugator and/or procerus muscle activity in adult patients up to 65 years of age. In addition to approximately 21 years of clinical experience, the safety and efficacy of BOTOX ® have been well-established in approximately 65 randomized, placebo-controlled clinical trials and in approximately 15,000 patients treated with BOTOX ® and BOTOX ® Cosmetic in Allergan’s clinical trials. 3 Worldwide, approximately 30 million vials of BOTOX ® and BOTOX ® Cosmetic have been distributed and approximately 29 million treatment sessions have been performed over the past 20 years (1990-2010). 4 With approximately 2,500 articles on BOTOX ® and BOTOX ® Cosmetic in scientific and medical journals, 5 BOTOX ® neurotoxin is one of the most widely researched medicines in the world. BOTOX ® (onabotulinumtoxinA) & BOTOX ® Cosmetic Important Information Indications BOTOX ® is a prescription medicine that is injected into muscles and used:
- to treat leakage of urine (incontinence) in adults with overactive bladder due to neurologic disease who still have leakage or experience too many side effects after trying an anticholinergic medication.
- to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
- to treat increased muscle stiffness in elbow, wrist, and finger muscles in people 18 years and older with upper limb spasticity
- to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
- to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities