IRVINE, Calif., June 23 /PRNewswire/ -- What: AHS 48th Annual Scientific Meeting: BOTOX(R) Scientific Sessions and Poster Presentations When: Thursday, June 22 - Sunday, June 25, 2006 Where: Hyatt Regency Century Plaza Hotel & Spa, Los Angeles, California PLEASE NOTE: All poster and presentation data are embargoed until time of presentation. BOTOX(R) and Headache/Migraine Poster Sessions
(All poster presentations noted below will take place on Friday, June 23 from 12:30 - 1:30 PM PDT in the California Show Room, and will be on display from 10 AM - 4 PM PDT)
Program to Assess Headache Treatment Strategies: An Observational Study of Botulinum Toxin Type A in the Preventive Treatment of Headache
[Poster F13] Silberstein SD, Mauskop A, Dodick DW, et al.
Botulinum Toxin Type A in the Treatment of Chronic Migraine Without Medication Overuse [Poster F19] Freitag F, Diamond S, Diamond M, Urban G, Brooks KE.
A Randomized, Double-Blind Comparison of Botulinum Toxin Type A (BOTOX(R)) and Divalproex Sodium (Depakote(R)) for the Prophylactic Treatment of Episodic Migraine: A Pilot Study
[Poster F14] Porter JAH, Hill EG, McKenzie B, Porter K, Williams Guynn N.
Botulinum Toxin Type A Compared with Divalproex Sodium for the Prophylactic Treatment of Migraine: A 9-month Randomized, Evaluator-Masked Trial
[Poster F15] Blumenfeld A, Schim J. Botulinum Toxin Type A (BOTOX(R)) for the Treatment of Migraine [Poster F17] Aurora SK.
Comparing the Relative Cost-Effectiveness of Oral Prophylactic Medications vs. Botulinum Toxin Type A (BOTOX(R)) in the Management of Migraine Headache: A Model Evaluating the Clinical and Economic Impact of Current Treatment Options
[Poster F16] Goldberg L.
Unilateralism as a Predictor of Response in Treatment of Chronic Headache Patients with Botulinum Toxin
[Poster F12] Lainez MJ, Gil R, Piera A, Lopez B, Santonja J.
Botulinum Toxin Type A (BoNT-A) for the Treatment of Cervicalgia and Headache: Results of a Single-Center, Randomized, Double-Blind, Active Placebo-Controlled Trial
[Poster F18] Stillman M, Cherian N, John O, Elchani Z, Mays M, Kunkel R. Single Site BOTOX Injection: Effective Treatment for Migraine Headaches [Poster F20] Kriegler JS, Pashmini N, Reed DA, Guyuron B. Epidemiology of Cervical Dystonia Platform Presentation
The Prevalence of Headache Attributed to Craniocervical Dystonia in Patients with Craniocervical Dystonia: A Multicenter, Descriptive Epidemiology Study
[Platform OR12] McAllister P, Bigal ME, Molho E, Freeman A, Dimitrova R, Brin MF.
* Friday, June 23 at 3:22 PM PDT; General Session Room
About BOTOX(R)
BOTOX(R) is a medical product that contains tiny amounts of highly purified botulinum toxin protein refined from a bacterium. The product is administered in small therapeutic doses by injection directly into the affected area, and works by blocking the release of acetylcholine (a neurotransmitter that signals the muscles to contract) at the neuromuscular junction.
BOTOX(R) therapy was granted approval by the FDA in 1989 for the treatment of strabismus (crossed eyes) and blepharospasm (uncontrollable eye blinking) associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above. BOTOX(R) has since received approval in December 2000 for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia. In 2002, with dosing specific to treat frown lines between the eyebrows, the product was approved by the FDA for the temporary improvement in the appearance of moderate to severe glabellar lines (the vertical "frown lines" between the eyebrows) in adult men and women aged 65 and younger, under the name BOTOX(R) Cosmetic. More recently, in July 2004, BOTOX(R) was granted FDA approval for the treatment of severe primary axillary hyperhidrosis (excessive underarm sweating) that is inadequately managed with topical agents.
Important Risk Information
BOTOX(R) and BOTOX(R) Cosmetic treatment is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any ingredient in the formulation. Serious and/or immediate hypersensitivity reactions have been rarely reported. These reactions include anaphylaxis, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs further injection of BOTOX(R) or BOTOX(R) Cosmetic should be discontinued and appropriate medical therapy immediately instituted. BOTOX(R) and BOTOX(R) Cosmetic should only be diluted with 0.9 percent non-preserved sodium chloride. Individuals with peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis, or motor neuropathy) or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should only receive BOTOX(R) or BOTOX(R) Cosmetic with caution. Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise from typical doses of BOTOX(R) or BOTOX(R) Cosmetic. There have been rare reports of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including cardiovascular disease. The exact relationship of these events to the botulinum toxin injection has not been established.
BOTOX(R) for Blepharospasm in Patients greater than or equal to 12 Years of Age: Reduced blinking from BOTOX(R) injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect and corneal perforation. The most frequently reported treatment-related adverse reactions in these patients are ptosis (20.8%), superficial punctate keratitis (6.3%) and eye dryness (6.3%). BOTOX(R) for Strabismus in Patients greater than or equal to 12 Years of Age: Inducing paralysis in one or more extraocular muscles may produce spatial disorientation, double vision or past pointing. The most commonly reported adverse effects are ptosis (16%) and vertical deviation (17%). BOTOX(R) for Cervical Dystonia in Adults: There have been rare cases of dysphagia severe enough to warrant the insertion of a gastric feeding tube. The most frequently reported adverse reactions in patients with cervical dystonia are dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%). BOTOX(R) for Severe Primary Axillary Hyperhidrosis Inadequately Managed with Topical Agents: Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis with out the diagnosis and/or treatment of the underlying disease. The most frequently reported adverse events (3 - 10%) are injection site pain and hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety. BOTOX(R) Cosmetic for Temporary Improvement in the Appearance of Moderate to Severe Frown Lines Between the Brows in adults less than or equal to 65: The most frequently reported adverse events are blepharoptosis (3.2%) and nausea (3%).
Full prescribing information for BOTOX(R) and BOTOX(R) Cosmetic is available at http://www.botox.com and http://www.botoxcosmetic.com.
About Allergan, Inc.
With more than 55 years of experience providing high-quality, science- based products, Allergan, Inc., with headquarters in Irvine, California, develops and commercializes products in the ophthalmology, neurosciences, medical dermatology, medical aesthetics, obesity intervention and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives.
Allergan, Inc.CONTACT: Cathy DiRamio of Allergan, Inc., +1-714-246-5551, office, or+1-310-498-1069, cell, Diramio_Cathy@allergan.com
