Xeomin (incobotulinumtoxinA), made by Merz Pharmaceuticals, is approved by the US FDA for the treatment of adults with cervical dystonia or blepharospasm. IncobotulinumtoxinA is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary reduction in muscle activity.
FDA approval of XEOMIN, was based on the results of two U.S. clinical trials. A study cited in the Journal of Neurological Sciences on the efficacy and safety of XEOMIN found it showed “non-inferiority” to Botox when used in the same doses to treat cervical dystonia. It concluded that XEOMIN is a safe and effective treatment for the disorder.
Xeomin is not yet approved for any cosmetic indications. By contrast, other drugs in this category, including Botox and Dysport, do have FDA approval for the treatment of facial wrinkles. Now that Xeomin is available and FDA approved, doctors can use it off-label to treat the same facial lines treated by Botox and Dysport, including frown lines, crow’s feet and forehead wrinkles.
Worldwide, more than 84,000 people have been treated with Xeomin injections. The U.S. is actually the 20th country to approve this new drug. It will be available in 50-unit and 100-unit vials.
Better or worse then Botox?
Xeomin is the first one that does not need to be refrigerated before use, which may simplify distribution. Xeomin is also has no additives, just botulinum toxin type A. This may mean that there is less risk of developing antibodies against Xeomin than other available neurotoxins. The body develops antibodies in response to a foreign invader and attacks. In theory, antibodies could prevent a neurotoxin from having its desired effects. The effects of Xeomin occur within one week, and the results last from three to six months, making it comparable to Botox in terms of both onset and duration of action. Xeomin should not be used interchangeably with other botulinum products
FDA approved in 2010 for use in the United States.
Approved since 2005 in Europe and is currently available in 20 countries worldwide.
Used to treat nearly a half million patients around the world.
The effects of XEOMIN have been studied in clinical trials worldwide.
Over 750 patients have received XEOMIN for cervical dystonia in clinical studies.
Over 400 patients have received XEOMIN for blepharospasm in clinical studies.
XEOMIN is manufactured in Germany.
A Treatment for You
Every person’s treatment needs are different, and the therapy you and your doctor choose should reflect that. Treatment with XEOMIN is individualized based on your condition and symptoms. Your doctor will decide how many muscles need to be injected and the dose per muscle:
The first effects of XEOMIN are typically seen within 7 days of treatment.
Everyone is different, so you should talk to your doctor if you have any questions or concerns about your treatment process.
And if you are already being treated with neurotoxin therapy, be sure to discuss with your doctor your previous treatment dose, response, and any side effects you may have experienced.