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| |  Canada Approves Botox (Botulinum Toxin Type A) For Axillary Hyperhidrosis MARKHAM, ON -- September 10, 2001 -- Allergan, Inc. today announced that Botox® (Botulinum Toxin Type A) Purified Neurotoxin Complex, has received approval by Health Canada's Therapeutic Products Programme for the treatment of hyperhidrosis (excessive sweating) of the axillae (underarm). This follows on the heels of Allergan's Canadian approval in April of Botox Cosmetic™ for the treatment of glabellar lines (brow furrow). Hyperhidrosis is a chronic disorder of excessive sweating that may affect any body part, particularly the underarm, palms, soles of the feet and face. This condition can cause significant problems in a patient's private and professional life and has been shown to have a negative impact on the emotional well-being of those suffering from the disease. To treat underarm hyperhidrosis, Botox is administered via tiny injections, within the skin of the affected area, to reduce excessive sweating by blocking the release of the chemical acetylcholine from the nerve fibres that stimulate overactive sweat glands. "Hyperhidrosis is a physical condition without a known cause, but one which can cause great personal anguish. We are thrilled with the approval from Health Canada for Botox therapy which now gives patients a new alternative to treat this condition," said Dr. Suzi Manara, Director, Medical Affairs, Allergan Canada. "The efficacy and patient satisfaction of Botox is considered to be excellent. Until now, most treatments for hyperhidrosis were often ineffective, short acting or had significant risks," said Nowell Solish, Dermatologist, Sunnybrook and Women's College Health Sciences Centre. "For those suffering from hyperhidrosis, Botox treatments give them new hope where previous therapies have failed before." In the double-blind clinical study for hyperhidrosis on which this approval was based, a Botox treatment was shown to work quickly, last for approximately four to seven months, and achieve high patient satisfaction. Patients treated with Botox demonstrated a responder rate of 95 percent at week one and 82 percent at week 16. The principal adverse reaction reported was the perceived increase in non-axillary sweating in 4.5 percent of those patients treated with Botox. It is important to note that the results reported in this study are based on the Botox formulation of botulinum toxin type A and cannot be generalized to other formulations or to other serotypes of botulinum toxin. Botox treatment was also approved in the United Kingdom for hyperhidrosis in July 2001. In Canada, Botox is currently approved for the treatment of cervical dystonia (involuntary head rotation caused by muscle spasm), blepharospasm (uncontrollable blinking), strabismus (crossed eyes), and equinus foot (deformity associated with juvenile cerebral palsy). Botox Cosmetic is approved for the treatment of glabellar lines (brow furrow). SOURCE: Allergan Inc. Related Links: Botox (Botulinum Toxin Type A) and Allergan Inc.
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