FRANKFURT, Germany, April 12, 2011 /PRNewswire/ -- Merz Pharmaceuticals today announced that results from sub-group analyses of a prospective, repeated dose, double-blind study evaluating the long-term safety and efficacy of XEOMIN® (incobotulinumtoxinA), a botulinum toxin type A free from accessory (complexing) proteins, will be presented at the 63rd Annual Meeting of the American Academy of Neurology (AAN) in Honolulu, Hawaii, U.S. The data show that repeated injections of XEOMIN resulted in sustained efficacy for up to 88 weeks in toxin-naive, as well as previously-treated cervical dystonia patients.
The first poster being presented at the meeting, titled "Efficacy and safety of repeated incobotulinumtoxinA injections in subjects with cervical dystonia previously naive to botulinum toxin treatment" written by Fernandez et al., concluded that treatment with 120 Units and 240 Units of XEOMIN resulted in sustained efficacy in the long-term treatment of toxin-naive cervical dystonia subjects and was generally well-tolerated for the study duration of up to 88 weeks. [P04.228 – Session P04: Movement Disorders: Treatment of Dystonia, April 13, 2011, 7:30 a.m. HST]
The second poster, titled "Efficacy and safety of repeated incobotulinumtoxinA injections in subjects with cervical dystonia previously treated with botulinum toxin" written by Evidente et al. concluded that long-term treatment with 120 Units and 240 Units of XEOMIN resulted in sustained efficacy in previously-treated subjects with cervical dystonia and was generally well-tolerated for the study duration of up to 88 weeks. [IN10-1.008 –Integrated Neuroscience Poster Session: Treatment of Movement Disorders, April 14, 2011, 2:30 p.m. HST]
The main outcome measures for both sub-groups included the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and treatment-emergent adverse events (TEAEs). Four weeks post-injection, there was a significant reduction in the average TWSTRS scores among both botulinum toxin-naive and previously treated patients. The most common TEAEs were dysphagia, neck pain, muscular weakness and injection site pain.
"The symptoms of cervical dystonia, including involuntary muscle spasms and abnormal postures, can cause pain and discomfort in many people, so it's important that physicians work closely with their patients to find the right treatment for each individual," said Hubert Fernandez, M.D., Center for Neurological Restoration, Cleveland Clinic, Ohio, and an investigator for XEOMIN. "The positive findings presented at AAN reinforce that XEOMIN is a safe and effective option for patients in need of long-term treatment for cervical dystonia."
In nature, Clostridium botulinum produces the toxin in association with accessory (complexing) proteins. Manufacturers utilize this naturally occurring protein complex to produce therapeutic botulinum toxin products. XEOMIN (incobotulinumtoxinA), is manufactured using a proprietary process that isolates the therapeutic component and eliminates accessory proteins.
More than 127,000 patients have been treated with XEOMIN worldwide since 2005. XEOMIN is approved in 21 countries worldwide for the treatment of cervical dystonia and blepharospasm and in 17 countries for the treatment post stroke upper limb spasticity. It is currently not approved in the U.S. for the treatment of post stroke upper limb spasticity.
XEOMIN is the only botulinum toxin product that does not require refrigeration prior to reconstitution.
Merz Pharmaceuticals GmbH (www.merz.com):
Merz Pharmaceuticals, a member of the Merz Pharma Group of companies, is an innovative and international specialty healthcare company specializing in the research, development and marketing of pharmaceuticals for the treatment of neurological and psychiatric diseases. In addition to developing XEOMIN®, the company has developed memantine (Axura®) -- the first drug for the treatment of moderate to severe Alzheimer's disease. The company also focuses on the development of innovative therapies within the therapeutic areas of hepatology, metabolic disease and dermatology.
XEOMIN is a registered trademark of Merz Pharma GmbH & Co KGaA.
SOURCE Merz Pharmaceuticals