Cosmetic use of Xeomin (Merz Pharmaceuticals] will be considered off-label use as of its initial US launch in September 2010. The drug was approved by the FDA in August 2010 only for treating neuromuscular conditions (i.e cervical dystonia &blepharospasm).
8 things you need to know about the release of Xeomen:
1) It is not yet approved to treat dynamic wrinkles (rhytids) between the brows and on the forehead.
2) Xeomin (incobotulinumtoxin A), has a unique formulation and does not contain any complexing proteins.
3) Xeomin’s formulation is not seen as a potential advantage over Dysport or Botox when it comes to cosmetic use. The doses used to smooth forehead wrinkles and frown lines is so low, there is no noticeable difference.
4) It may be more difficult to control spreading or migration of Xeomin (than with Botox), which may lead to muscle relaxation that causes droopy eyebrows and other undesirable results.
5) The effects of Xeomin injections for wrinkle reduction are anticipated to closely mirror the effects of Botox injections.
6) The unit measurements of Xeomen and Botox are expected to be about the same. Botox is currently distributed in 100-unit vials. Xeomin will be distributed in 50-unit and 100-unit vials.
7) Xeomin will not require refrigeration prior to reconstitution. Botox and Dysport do require refrigeration at all times.
8) Since the introduction of Dysport onto the cosmetic market did not affect the price point on Botox injections, it is unlikely that the introduction of Xeomin will either.