At the 5th International Dystonia Symposium (IDS) in Barcelona, Spain (20-22 October 2011), Merz Pharmaceuticals presented important clinical data concerning the long-term, sustained efficacy and safety of XEOMIN® for the treatment of patients with dystonia.
Dystonia is a particularly debilitating condition where involuntary muscle contractions can cause abnormal twisting, postures or movements, and is the third most common movement disorder after essential tremor and Parkinson's disease. New data presented at recent neurological congresses and summarized at the IDS indicate that patients treated with XEOMIN® for cervical dystonia or blepharospasm (involuntary closing of the eyelids) experienced long-term sustained efficacy with a favorable safety profile in studies of up to 121 and 88 weeks duration, respectively. Furthermore, the incidence of adverse events decreased with each injection session, indicating no cumulative effect of the drug with repeated treatments. Professor Alberto Albanese from the Istituto Neurologico Carlo Besta, Milan, Italy, who is the lead author of the recently published new European Federation of Neurological Societies guidelines on the diagnosis and treatment of dystonia, stated that "Botulinum neurotoxin type A should be regarded as the first-line treatment for patients with dystonia. It is also important to know that repeated treatments are safe and efficacious over many years. These data give physicians more confidence in using this medication over the long term".
Professor Alberto Albanese indicated that "most patients with dystonia require long-term treatment. Moreover flexibility is needed with respect to time interval between treatment sessions to facilitate individualized care. Long-term clinical studies involving XEOMIN® are unique in being able to show that patients can be dosed safely also with injection intervals ranging from 6 to 20 weeks". Individualized patient treatment also requires the use of different doses depending on the severity of dystonia and the muscle affected. XEOMIN® is now available in both 100 and 50 unit vials, which limits product wastage and may result in significant cost savings for healthcare providers.
Comparative clinical study results suggest that XEOMIN® and the comparator product containing conventional Botulinum toxin type A complex (900 kD) are of equal potency when used with a dosing conversion ratio of 1:1. In addition, XEOMIN® is the only product in its class to be refined by an FDA-approved state-of-the-art biotechnology process to remove the unnecessary accessory or complexing proteins that would otherwise be injected into the patient along with the active 150 kD neurotoxin.
Merz Pharmaceuticals GmbH