FDA approves Botox for treatment of severe underarm sweating

FDA approves Botox for treatment of severe underarm sweating

IRVINE, CALIF., July 20, 2004 -- Allergan Inc. announced that the FDA has approved Botox (botulinum toxin type A) for the treatment of severe primary axillary hyperhidrosis (severe underarm sweating) that is inadequately managed with topical agents.

Botox was first approved in December 1989 to treat two eye muscle disorders (blepharospasm and strabismus). Since then it has been approved to treat cervical dystonia, a neurological movement disorder causing severe neck and shoulder muscle contractions. Most recently, in 2002, it was approved as Botox Cosmetic to temporarily improve the appearance of moderate to severe frown lines between the eyebrows.

Primary axillary hyperhidrosis often goes undiagnosed, misdiagnosed and untreated due to lack of awareness on the part of the patients and physicians alike. 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.

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, haryngitis, flu-syndrome, headache, fever, neck or back pain, pruritus and anxiety.

The safety and effectiveness of Botox for hyperhidrosis in body areas other than the axillae (armpits) has not been established. Because Botox is a prescription drug, it must be used carefully under medical supervision for all the product's approved indications.

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."

For more information about hyperhidrosis, visit the International Hyperhidrosis Society's website at www.SweatHelp.org.

For more information about hyperhidrosis treatment with Botox, as well as the prescribing information, visit www.botox.com/hyperhidrosis.

Source: Allergan and FDA

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