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| |  Canada Approves Botox (Botulinum Toxin Type A) For Focal Spasticity MARKHAM, ON -- November 5, 2001 -- Allergan, Inc. today announced that Botox® (botulinum toxin type A) has received approval from Health Canada for the management of focal spasticity, including the treatment of upper limb spasticity associated with stroke in adults. Post-stroke adult spasticity occurs when the muscle does not respond to the nervous system's signal to relax. As a result, the muscle remains contracted, which can result in pain, restricted mobility and seriously interfere with the patient's ability to perform daily activities such as dressing and hygiene. Characteristic postures of a patient suffering from spasticity may be a clenched fist, flexed wrist, bent elbow or arm pressed against the chest. Botox injection therapy treats spasticity by directly targeting the affected muscle to block the release of acetylcholine, thereby allowing the muscle to relax. In a Phase 3, randomized, multi-centre, placebo-controlled parallel trial, the safety and efficacy of Botox therapy in the treatment of wrist and finger spasticity after stroke, as well as the effect on the functional disabilities of hygiene, dressing, pain and limb position, were evaluated in 126 patients. At all post-treatment visits, Botox therapy was shown to be clinically and statistically superior versus placebo in decreasing wrist and finger flexor muscle tone as measured on the Ashworth scale with the maximum difference occurring at week four. The patient/caregiver global assessment showed improvement in those treated with Botox at all post-injection visits. There was also significant improvement favoring Botox in a targeted, patient-selected disability rating starting four weeks after treatment. The treatment effect was sustained, even up to the end of the study, which concluded 16 weeks after treatment. Results from this study indicate that Botox safely and effectively decreases post-stroke spasticity and improves functional disability in daily life for at least three months after the first treatment. The most commonly reported adverse events reported during the trial were mild in severity and included pain at the injection site (7.8 percent), headache, dizziness and muscle weakness (6.3 percent). "This is the first large study to demonstrate the functional improvement we as physicians see with Botox therapy in our patients," said Allison Brashear, M.D., Associate Professor, Indiana University School of Medicine and principal investigator for this study. "Botox therapy plays a significant role in reducing spasticity and helping patients to achieve greater functional improvements in hygiene, dressing, limb placement and pain". "This is a great leap forward in safely treating these patients who have a targeted, focal muscle hyperactivity," said Dr. Suzi Manara, Allergan Canada's Director of Medical Affairs. "Through Botox therapy, many patients may have significant improvement in their quality of life." Botox treatment was also granted a positive opinion from the European Union covering fourteen European countries for upper limb adult spasticity in October 2001. In Canada, Botox is also approved for the treatment of hyperhidrosis, 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: Allergen Inc.
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