GREENSBORO, N.C., Nov. 5, 2010 /PRNewswire/ -- Merz Pharmaceuticals announced today that data from stability and clinical studies evaluating Xeomin® (incobotulinumtoxinA), a botulinum toxin type A free from accessory proteins, will be presented at the 71st Annual Assembly of the American Academy of Physical Medicine and Rehabilitation (AAPM&R) in Seattle, Wash.
The U.S. Food and Drug Administration (FDA) approved XEOMIN on July 30, 2010, for the treatment of adults with cervical dystonia (CD), to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naive and previously treated patients, and blepharospasm in adults who have been previously treated with Botox® (onabotulinumtoxinA). Stability StudiesAs part of the commercial development of XEOMIN, Merz conducted studies to assess the stability of XEOMIN and the 900 kDa neurotoxin complex which is produced by Clostridium botulinum. In nature, Clostridium botulinum produces the 150 kDa neurotoxin molecule with accessory proteins, resulting in a complex with a molecular weight of 900 kDa.
Results from a study designed to assess the stability of the 900 kDa neurotoxin complex at various pH values concluded that the 150 kDa neurotoxin molecule was released in less than one minute when exposed to physiological pH values. In the study, separation conditions were qualified by Western blot and toxin activity. (Poster 108; Eisele K.H., et al.)
In a second study, the stability of three individual batches of XEOMIN was assessed in long-term and accelerated stability studies according to the ICH Q1A(R2) guideline on stability testing of drug products. The results of this study showed that the product can be safely stored without refrigeration and is not affected by short-term temperature stress between 40°C (104°F) and 60°C (140°F). (Poster 106; Grein S., et al.)
"According to these data, the speed at which accessory proteins disassociate from the neurotoxin molecule at physiological pH suggests that the necessity of these proteins in medicinal formulations of botulinum toxin type A is questionable in influencing the therapeutic effects," said Eric J. Pappert, M.D., Vice President of Medical Affairs, Merz Pharmaceuticals, LLC. "Additionally, results from the stability studies evaluating XEOMIN under various conditions suggest that accessory proteins are not required for the long-term maintenance of potency of this medicinal formulation of botulinum toxin type A."
Clinical StudiesThe results of studies exploring the safety and efficacy of XEOMIN in the treatment of adults with cervical dystonia, blepharospasm and post-stroke spasticity of the upper limb will also be presented:
About XEOMINIn nature, Clostridium botulinum produces the toxin in association with accessory proteins, resulting in a 900 kDa complex. Manufacturers utilize this naturally occurring protein complex to produce therapeutic botulinum toxin products. Merz has introduced XEOMIN (incobotulinumtoxinA), manufactured using a proprietary process that isolates the therapeutic component and eliminates accessory proteins, yielding a 150 kDa neurotoxin molecule.
More than 84,000 patient shave been treated with XEOMIN worldwide since 2005. The U.S. is the 20th country to approve XEOMIN for the treatment of cervical dystonia and blepharospasm.
XEOMIN is the only botulinum toxin that does not require refrigeration prior to reconstitution. XEOMIN is available in 50-unit and 100-unit vials, which Merz believes may allow for more precise billing and reduce wastage.
IMPORTANT SAFETY INFORMATIONWARNING: Distant Spread of Toxin EffectPostmarketing reports indicate that the effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.CONTRAINDICATIONSXEOMIN is contraindicated in patients with a known hypersensitivity to the active substance botulinum toxin type A or to any of the components in the formulation and in the presence of infection at the proposed injection site(s).
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSCervical Dystonia: The most commonly observed adverse reactions (incidence ≥10% of patients and twice the rate of placebo) for XEOMIN 120 Units and XEOMIN 240 Units, respectively, were: dysphagia (13%, 18%), neck pain (7%, 15%), muscle weakness (7%, 11%), and musculoskeletal pain (7%, 4%).
Blepharospasm: The most common adverse reactions (incidence ≥10% of patients and twice the rate of placebo) for XEOMIN were eyelid ptosis (19%), dry mouth (16%), visual impairment (12%), diarrhea (8%), and headache (7%).
DRUG INTERACTIONSConcomitant treatment of XEOMIN and aminoglycoside antibiotics, spectinomycin, or other agents that interfere with neuromuscular transmission (e.g., tubocurarine-like agents), or muscle relaxants, should be observed closely because the effect of XEOMIN may be potentiated.
USE IN PREGNANCYPregnancy Category C: There are no adequate and well-controlled studies in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Please see full prescribing information for XEOMIN, including Boxed WARNING, available at www.XEOMIN.com. About MerzMerz Pharmaceuticals, LLC is a part of the Merz Group of companies and was established in 1995 to develop and commercialize products for the Merz Group. Areas of therapeutic focus include Neurology, Dermatology, and Podiatry.
With a 102 year heritage, the Merz Group is known worldwide for its development of original compounds and formulations for medical professionals and consumers in 90 countries. Globally, Merz is a leader in the development of pharmaceuticals for the treatment of neurological and psychological disorders as well as for aesthetic medicine. Global research is concentrated in fields that have a strong need for therapeutic innovation such as Alzheimer's disease, Parkinson's disease, tinnitus, chronic pain conditions, addictions, and neuromuscular disturbances.
XEOMIN is a registered trademark of MerzPharma GmbH & Co KGaA. Botox is a registered trademark of Allergan, Inc.
|SOURCE Merz Pharmaceuticals|
Copyright©2010 PR Newswire.
All rights reserved