FRANKFURT, Nov. 18 /CNW/ -- Today, Merz Pharmaceuticals announced that European health authorities have reached an agreement on a new indication of Xeomin® for the symptomatic treatment of post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults. The agreed label now has to be nationally approved by each of the selected European member states within the next months. Xeomin® was first introduced in Germany as of 2005 and is currently approved in 19 countries worldwide for the treatment of various movement disorders. Xeomin® was already granted approval for post-stroke spasticity of the upper limb in Canada as well as for spasticity in Mexico and for focal spasticity in Argentina.
This important extension of indication is based on the Kanovsky study, the largest randomized, placebo-controlled, double-blind trial with a botulinum toxin in upper limb post-stroke spasticity to date.
Dr. Alexander Gebauer, Chief Scientific Officer, Head of Global R&D, Merz Pharmaceuticals, Frankfurt, Germany, said: "In addition to the impact it has on the day-to-day life activities, post-stroke spasticity can cause significant pain and discomfort to patients. The favorable outcomes in terms of efficacy and safety suggest Xeomin® may give promise to patients in search of a treatment option for post-stroke spasticity."
Worldwide, an estimated 12 million people are affected by spasticity, the majority of cases resulting from stroke. Aside from the pain and significant discomfort, post-stroke spasticity can negatively influence mobility, the ability to carry out personal hygiene, and other activities of daily living.
Xeomin® is a botulinum neurotoxin type A free from complexing proteins and currently approved in various European countries for the symptomatic treatment of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults.
Merz Pharmaceuticals GmbH (www.merz.com):
Merz Pharmaceuticals, a member of the Merz Group of companies, is an innovative and international healthcare company specializing in the research, development and marketing of pharmaceuticals for the treatment of neurological and psychiatric diseases. Merz is a leader in the field of neurology and has developed Xeomin®, a botulinum neurotoxin type A free from complexing proteins, as well as memantine (Axura®/Akatinol®), the first drug for the treatment of moderate to severe Alzheimer's disease. Other franchises covered by Merz are hepatology / metabolic diseases and dermatology.
SOURCE MERZ PHARMACEUTICALS
For further information: For further information: Dawn Sciortino, +1-212-537-9495 Web Site: http://www.merz.com