New Scientific Data on Allergan's Botox (Botulinum Toxin Type A) Presented at the American Academy of Physical Medicine and Rehabilitation 68th Annual Assembly
IRVINE, Calif., Sept. 27, 2007-New data on several potential therapeutic uses being investigated for Allergan's BOTOX(r) (Botulinum Toxin Type A), such as headache and migraine, post-stroke spasticity, and neuropathic pain, will be presented at this year's American Academy of Physical Medicine and Rehabilitation (AAPM&R) Annual Assembly in Boston, MA.
What: AAPM&R Annual Assembly: BOTOX(r) Scientific Sessions and Poster Presentations
When: Thursday, September 27 - Sunday, September 30, 2007
Where: Hynes Convention Center, Boston, MA
Please Note: All poster and presentation data are embargoed until time of presentation.
Saturday, Sept. 29, 2007
The Effect of Repeated Treatment of Botulinum Toxin Type A on Poststroke, Spasticity-Related Pain: A Subgroup Analysis of Patients in a 12-Month Trial
Elie Elovic. Allison Brashear, et al.
* Saturday, September 29 at 9:30 AM - 11::30 AM; Exhibit Hall C/D
The Effect of Botulinum Toxin Type A on Walking Speed in Poststroke Patients: A Subgroup Analysis of Patients in a Two-Part, 32-Week, Multicenter Study
John D. Rogers, John Oliver, et al.
* Saturday, September 29 at 9:30 AM - 11::30 AM; Exhibit Hall C/D
Passive and Active Functional Tasks Are the Main Reasons for Treatment of Upper Limb Spasticity in Poststroke Patients Among Neurologists, Physiatrists, and Primary Care Physicians
Amanda M. VanDenburgh, Susan Abushakra, et.al.
* Saturday, September 29 at 9:30 AM - 11::30 AM; Exhibit Hall C/D
Contact: Cathy Taylor
Allergan, Inc.
714-246-5551 (office)
949-293-4453 (cell)
Taylor_Cathy@allergan.com Diramio_Cathy@allergan.com>
About BOTOX(r) (Botulinum Toxin Type A)
BOTOX(r) (Botulinum Toxin Type A) 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) neurotoxin 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. The efficacy of BOTOX(r) treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane's syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established. BOTOX(r) is ineffective in chronic paralytic strabismus except when used in conjunction with surgical repair to reduce antagonist contracture.
BOTOX(r) neurotoxin 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 should not be injected in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any ingredient in the formulation.
Serious heart problems and serious allergic reactions have been reported rarely. If you think you're having an allergic reaction or other unusual symptoms, such as difficulty swallowing, speaking or breathing, call your doctor immediately. 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 side effects with BOTOX(r) or BOTOX(r) Cosmetic.
BOTOX(r) for Blepharospasm in Patients > 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 > 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: 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 <65: The most common side effects following injection include temporary eyelid droop and nausea. Localized pain, infection, inflammation, tenderness, swelling, redness and/or bleeding/bruising may be associated with the injection.
Please see enclosed full prescribing information for BOTOX(r) and BOTOX(r) Cosmetic.
About Allergan, Inc.
With more than 55 years of experience providing high-quality, science-based products, Allergan, Inc., with headquarters in Irvine, California, discovers, 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.
(c) 2007, Allergan, Inc. Irvine, CA 92612. (r) mark owned by Al
Posted: September 2007
