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.
PIPELINE PREVIEWS IS A FEATURE THAT WILL APPEAR IN EACH ISSUE. IT WILL BRING TO YOU INFORMATION ON THE NEWEST DRUGS AND MEDICAL PRODUCTS AS THEY BECOME AVAILABLE TO THE DERMATOLOGICAL COMMUNITY.
THESE FEATURES MAY INCLUDE ADDITIONAL INFORMATION FROM THE MANUFACTURERS, PLUS REPORTS FROM PHYSICIANS WHO WISH TO SHARE THEIR CLINICAL EXPERIENCE WITH THESE NEW PRODUCTS. IN ADDITION, WE WILL INFORM OUR READERS ABOUT THE LATEST DRUGS RECEIVING FDA APPROVAL. WE TRUST YOU WILL FIND THIS INFORMATION BENEFICIAL IN YOUR PRACTICE AND RESEARCH.
COPYRIGHT 2004 Journal of Drugs in Dermatology, Inc.
COPYRIGHT 2005 Gale Group
Hyperhidrosis or Excessive Sweating
What is hyperhidrosis?
Where does hyperhidrosis occur?
What are the symptoms of hyperhidrosis?
What are the alternative treatments for hyperhidrosis?
Is there a surgical treatment for hyperhidrosis?
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Boston, Massachussetts
"It's so awesome! I'm really glad I went to cure my hyperhidrosis. It's great to be able to go to the gym
and not sweat on my hands, face, head, or feet. Thank you so much!" |
Reno, Nevada
"Thank you, for curing of my hyperhidrosis. Your staff was compassionate, caring,
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Everything was thoroughly explained in detail to me. I can't wait to tell everyone how successful my
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Irvine, California
"As a little boy, I already had sweaty palms. I was miserable because this condition
had been with me all my life. I dreaded attending church or social gatherings
because it meant I had to face others. Also, I had difficulty handling tools at
work because everything I touched became wet. I am very happy with the result
of my surgery. Thanks for curing my hyperhidrosis. I feel years
younger. I highly recommend Hyperhidrosis Center™ to anyone who is suffering from palmar hyperhidrosis."
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Helena, Montana
"I tried medicines--from Beta Blockers--to lotions--to antipsychotics, but to no avail.
I was using Drysol. At the beginning it was great. I had dry hands for two
weeks in- between doses. Then slowly, the medication started to lose its affect
on me. Instead of applying once every two weeks it was once every two days.
I started to look on the Internet for other alternatives and found the website for the treating hyperhidrosis."
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Waikiki, Hawaii "I strongly suggest that anyone suffering from sweaty palms should consult
the doctor to have the surgery. I suffered from this problem for more than
20 years, and now there is no more hyperhidrosis." |
Houston, Texas "I am very happy to come to California to have removal of my hyperhidrosis. Both my hands and feet are now dry. If anyone in
the Houston, Texas area would like to talk with me, it's okay. Please
call Hyperhidrosis Center™ at 1-866-PALM-911 for my number."
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