The FDA approval of XEOMIN is based on the results of two pivotal U.S. clinical trials involving 16 investigational sites and included 547 healthy adult patients. In both studies, XEOMIN significantly improved the appearance of glabellar lines 30 days following the first injection, when compared to placebo. XEOMIN is the only botulinum toxin currently approved in the U.S. that does not require refrigeration prior to reconstitution.
“XEOMIN is a promising new option for both patients and physicians and we are encouraged by the response rates seen in the Phase III clinical trials,” said Derek H. Jones, M.D., an investigator for the XEOMIN U.S. study, Clinical Associate Professor of Medicine at the University of California in Los Angeles, Calif., and Director of Skin Care and Laser Physicians in Beverly Hills, Calif.
Xeomin is used in 14 worldwide locations and in the EU under the name Bocouture. As with all botulinum toxins, there are safety warnings that must be made public.