FDA approves Botox for hyperhidrosis

Journal of Drugs in Dermatology Nov-Dec, 2004

Allergan has received Food and Drug Administration (FDA) approval of Botulinum Toxin Type A (Botox) for the treatment of axillary hyperhidrosis that is refractory to topical treatments. Botox has already been approved for several other purposes including the treatment of moderate to severe glabellar frown lines. It has been approved for hyperhidrosis in Canada for over two years and has been used off-label for this indication in the United States. Botulinum Toxin Type A is a protein produced by the bacterium Clostridium botulinum. When used to treat primary axillary hyperhidrosis, small doses of an injectable form of the sterile purified botulinum toxin halt release of acetylcholine, temporarily blocking the nerves in the axillae that stimulate sweating.

The FDA approval of Botox for hyperhidrosis was based on two randomized, double blind, placebo-controlled, multicenter clinical trials involving over 600 adults. Subjects who received Botox had significantly reduced underarm sweating as compared to the placebo group. In one study, 91% of subjects in the treatment arm showed a 50% reduction in sweating at four weeks compared to 36% in the placebo group. Another study demonstrated an average duration of response of 170 days following one treatment. The most common adverse events following injection (occurring in 3-10% of patients) included injection site pain and hemorrhage, sweating in other parts of the body, flu-like symptoms, headache, fever, itching, and anxiety.

Before being treated for primary axillary hyperhidrosis, it is recommended that patients be evaluated for other potential causes of hyperhidrosis, such as hyperthyroidism.

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