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| |  FDA Approves Botox (Botulinum Toxin Type A) for Treatment of Severe Underarm Sweating IRVINE, CA -- July 20, 2004 -- Allergan, Inc. (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) approved BOTOX® (botulinum toxin type A) for the treatment of severe primary axillary hyperhidrosis (severe underarm sweating) that is inadequately managed with topical agents. Primary axillary hyperhidrosis often goes undiagnosed, misdiagnosed and untreated due to lack of awareness on the part of the patients and physicians alike. "The FDA approval of Botox® for severe primary axillary hyperhidrosis that is inadequately managed with topical agents represents an important new treatment option for people living with this disease," said Dr. Mitchell Brin, Senior Vice President of Development, Botox® and Neurology, Allergan, Inc. "It also marks another milestone in the history of Botox®, which continues to demonstrate its versatility in meeting patients' medical needs." Hyperhidrosis is a medical disorder that results in sweating that exceeds the normal amount required to maintain consistent body temperature. Severe underarm sweating that is not adequately managed by topical agents has been shown to frequently interfere with one's daily activities. "Most people who live with severe primary axillary hyperhidrosis do not realize that they have a chronic, distinct medical condition, despite the fact that they may sweat through several changes of clothes each day," said Lisa J. Pieretti, Executive Director of the International Hyperhidrosis Society. "Some patients are misdiagnosed with anxiety disorders or told that they cannot be effectively treated or that the only treatment options are highly invasive. The approval of Botox® to treat severe primary axillary hyperhidrosis that is not adequately managed with topical agents is significant news for these patients, whose daily lives are negatively impacted due to this treatable medical condition. Although not a cure, this is a milestone in hyperhidrosis research and a new treatment option that may bring hope and relief to the lives of many of those patients with this disease who adequately respond to this treatment." The FDA approval was based on the results of two Phase III clinical studies (one in the U.S. and one in Europe). In the U.S. study, significantly more patients receiving Botox® vs. placebo achieved at least a 2-grade improvement from baseline on the 4-point Hyperhidrosis Disease Severity Scale (HDSS), which assesses the severity of primary axillary hyperhidrosis and how it affects a patient's daily activities. Quantity of underarm sweat production also was significantly decreased. To achieve these results, 1-2 Botox® treatments were sufficient for most patients who responded in the 52 week pivotal clinical study. Repeat injections with BOTOX® for hyperhidrosis should be administered when the clinical effect of a previous injection diminishes. "When current topical treatments do not produce the desired results, Botox® may provide many patients living with severe primary axillary hyperhidrosis with an effective alternative," said Dee Anna Glaser, M.D., Associate Professor of Dermatology and Vice Chairman, Department of Dermatology, at Saint Louis University School of Medicine, and lead investigator for the Phase III clinical study. Results of the U.S. Pivotal Phase III Clinical Study Following screening, 322 patients were randomized to one of three treatment groups (50 units of Botox® per underarm, 75 units of Botox® per underarm or placebo) and were evaluated at one week after treatment and every four weeks thereafter. The primary efficacy evaluation was patient assessment of hyperhidrosis severity using the HDSS. The following results were observed: · 55 percent of patients treated with BOTOX® 50 Units per underarm, 49 percent of patients treated with BOTOX® 75 Units per underarm and 6 percent treated with placebo (P <.001) were considered responders. Study responders were defined as patients who showed at least a 2-grade improvement from baseline value on the HDSS 4 weeks after both of the first two treatment sessions or had a sustained response after their first treatment session and did not receive re-treatment during the study. (BOTOX® 50 Units - 95% CI: 38.8, 59.7) (BOTOX® 75 Units - 95% CI: 33.2, 53.8). · Four weeks after their first treatment, 81 percent of patients treated with BOTOX® 50 Units per underarm and 86 percent of patients treated with BOTOX® 75 Units per underarm experienced a greater than 50 percent decrease in axillary sweat production versus 41 percent of placebo patients (BOTOX® 50 Units - 95% CI: 28.1, 52.0) (BOTOX® 75 Units - 95% CI: 33.3, 56.1). · Median duration of response was 6.5 months, or 201 days.
Important Risk Information Botox® 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® should be discontinued and appropriate medical therapy should be immediately instituted. BOTOX® should only be diluted with 0.9 percent non-preserved sodium chloride. Other diluents, including lidocaine, should not be used for reconstitution. 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® with caution. Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise with typical doses of Botox®. Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease. The most frequently reported adverse events (3-10%) were injection site pain and hemorrhage, non-axillary sweating, infection, pharyngitis, flu-syndrome, headache, fever, neck or back pain, pruritus and anxiety. Hyperhidrosis Disease Severity Scale (HDSS) Hyperhidrosis can be measured using the Hyperhidrosis Disease Severity Scale (HDSS), a 4-point scale designed to assess the severity of primary axillary hyperhidrosis in everyday clinical practice or in clinical research. The HDSS can be administered by an interviewer or self-completed by the patient. Patients rate the severity as: · 1= "Underarm sweating never noticeable/never interferes with daily activities"; · 2= "Underarm sweating tolerable/sometimes interferes with my daily activities"; · 3= "Underarm sweating barely tolerable/frequently interferes with my daily activities"; · 4= "Underarm sweating intolerable/always interferes with my daily activities". About Botox® Botox® is a sterile, purified protein that works by blocking the nerve impulses that, in the case of severe primary axillary hyperhidrosis, cause sweat glands to be stimulated. Severe primary axillary hyperhidrosis ineffectively managed with topical agents marks the fourth therapeutic indication for Botox® in the U.S. Worldwide, Botox® is currently one of the most widely researched medicines with approximately 20 approved indications in more than 70 countries.
SOURCE: Allergan, Inc.
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