Xeomin (incobotulinumtoxinA), made by Merz Pharmaceuticals, is approved by the US FDA for the treatment of adults with cervical dystonia or blepharospasm and Moderate to severe frown lines between the eyebrows. 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 has now been approved for some cosmetic indications – Moderate to severe frown lines between the eyebrows. Similiar to other drugs in this category, including Botox and Dysport, that also have FDA approval for the treatment of facial wrinkles. Now that Xeomin is available and FDA approved, doctors can use it both on-label and 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 is 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.