The FDA approved a new botulinum toxin type A on August 2 for the treatment of adults with cervical dystonia and blepharospasm. XEOMIN is the third product of this kind to be approved in the U.S., after Botox and Dysport.
XEOMIN’s approval is 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 concluded that it is a safe and effective treatment for cervical dystonia. It said that XEOMIN showed non-inferiority to Botox when used in the same doses to treat the disorder. Dystonias are neurological movement disorders in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. Cervical dystonia is characterized by twisting of the neck and blepharospasm by excessive eyelid spasms.
XEOMIN is the only botulinum toxin that doesn’t require refrigeration prior to reconstitution. Merz Pharmaceuticals, the maker of XEOMIN, believes this could simplify product distribution and storage and help ensure product integrity at the time of injection.
In early 2010, Merz announced it would be acquiring BioForm Medical, a leader in the dermal filler market with its Radiesse filler. Once the acquisition is complete, Merz and will be renamed Merz Aesthetics.
Despite growing competition, Botox the first botulinum toxin approved by the FDA is showing strong sales. According to Allergan’s latest earnings report, Botox sales rose 7 percent in the quarter to $360.5 million. Allergan said it now believes the drug will post sales of $1.36 billion to $1.39 billion this year, which compares with a forecast in February for $1.33 billion to $1.37 billion.