A third botulinum toxin type A product has been approved by the FDA. XEOMIN, a product of Merz Pharmaceuticals, earned approval last week for the treatment of adults with cervical dystonia or blepharospasm. The FDA approval of XEOMIN is based on the results of two U.S. clinical trials. It joins Botox and Dysport as botulinum toxins to receive clearance in the United States.
Both cervical dystonia and blepharospasm are neurological disorders. Cervical dystonia is characterized by twisting of the neck and blepharospasm by excessive eyelid spasms.
A study on the efficacy and safety of XEOMIN cited in the Journal of Neurological Sciences concluded that XEOMIN is a safe and effective treatment for cervical dystonia. XEOMIN showed “non-inferiority” to Botox when used in the same doses to treat the disorder.
One way in which XEOMIN differs from Botox and Dysport is that it’s the only botulinum toxin that doesn’t require refrigeration prior to reconstitution. Merz therefore believes this may “simplify product distribution and storage and help ensure product integrity at the time of injection.”
While XEOMIN has not been approved for cosmetic uses, some doctors may start to offer it as an off-label option. Another indicator that Merz is moving into the aesthetic arena is its acquisition of BioForm Medical earlier this year. BioForm Medial makes the popular dermal filler Radiesse, and following completion of the acquisition of, Merz and will change its name to “Merz Aesthetics.”
Despite the competition to Botox—first from Dysport and now potentially XEOMIN—the product is still showing strong sales. Allergan’s latest earnings release reported that Botox sales rose 7 percent in the quarter to $360.5 million. The company is also hoping it wins U.S. approval to sell Botox to treat migraine headaches in the near future. In July it was approved for this use in the U.K.