XEOMIN® (incobotulinumtoxinA) Data to be Presented at the 64th Annual Meeting of the American Academy of Neurology
Phase 4 XCiDaBLE Trial Evaluates Use of XEOMIN for Cervical Dystonia or Blepharospasm in the U.S.
GREENSBORO, N.C., April 23, 2012 /PRNewswire/ -- Merz Pharmaceuticals today announced that initial baseline data from an ongoing Phase 4 Trial Evaluating XEOMIN® (incobotulinumtoxinA) for Cervical Dystonia (CD) and Blepharospasm in the United States (XCiDaBLE) will be presented at the 64th American Academy of Neurology (AAN) Annual Meeting in New Orleans, La.
XEOMIN is approved for the treatment of cervical dystonia in adults, 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).
The Phase 4, prospective, observational trial is expected to provide insight into the clinical use of XEOMIN in a "real world" setting to determine injection patterns and use of guidance techniques. The initial data presented at AAN Annual Meeting is based on 130 CD and 184 blepharospasm patients who were enrolled in the XCiDaBLE trial as of September 1, 2011.
"Cervical dystonia and blepharospasm are chronic and often debilitating conditions that affect each patient differently," said lead investigator Hubert Fernandez, M.D., Center for Neurological Restoration, Cleveland Clinic, Ohio. "The XCiDaBLE trial provides valuable information about disease severity, employment history and quality of life among people living with these conditions. This research demonstrates Merz's continued commitment to improving patient care and providing physicians with important information about 'real-world' experience with XEOMIN."
The first poster to be presented at the meeting is titled "XCiDaBLE: A Phase 4, Observational, Prospective Trial Evaluating Xeomin (incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States – Preliminary Baseline Employment History Data". [P01.238: Poster Session 1, Monday, April 23, 2 – 6 p.m. ET].
The second poster presented at the meeting is titled "XCiDaBLE: A Phase 4, Observational, Prospective Trial Evaluating Xeomin (incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States- Preliminary Baseline Disease Severity and Quality of Life Data". [P01.240: Poster Session 1, Monday, April 23, 2 – 6 p.m. ET].
Additional XEOMIN poster presentations at the AAN Annual Meeting will report data regarding injection intervals in the treatment of cervical dystonia and blepharospasm.:
- P01.219: (Fernandez, et al; Poster Session 1, Monday, April 23, 2 – 6 p.m. ET)
- PD4.010: (Evidente, et al; Poster Discussion Session IV, Wednesday, April 25, 7:30 a.m. – 12 p.m. ET)
The information in this press release is intended solely to alert the reader to the availability of new baseline data from an ongoing Phase 4 trial evaluating XEOMIN®, and is not intended to constitute solicitation of any customers to whom solicitation is prohibited by court order. XEOMIN® is not currently available for sale in the therapeutic market to certain customers in certain areas of the country.
The Phase 4 Trial Evaluating XEOMIN (incobotulinumtoxinA) for cervical dystonia or blepharospasm in the United States (XCiDaBLE) is a prospective, observational study. Physicians may enroll adult patients with CD or blepharospasm who are eligible to be treated with a botulinum toxin, based on their clinical experience. The physician must choose to treat the patient with XEOMIN prior to and independent of enrollment in the study. Physicians may choose to treat their subjects with up to two treatment cycles (approximately 6 months/subject) of XEOMIN at a dose determined by the physician based upon his/her clinical experience with botulinum toxin, and subjects are monitored via interactive voice/web response. For more information about the trial, visit http://clinicaltrials.gov/ct2/show/NCT01287247.
C. botulinum produces the toxin in association with accessory proteins (toxin complex). Merz takes the toxin complex and employs a proprietary manufacturing process that isolates the therapeutic component and removes the accessory proteins to produce XEOMIN.
More than 250,000 patients have 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 product 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 INFORMATION
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing 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 [see Warnings and Precautions (5.1)].
XEOMIN 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
- The potency units of XEOMIN are not interchangeable with other preparations of botulinum toxin products. Therefore, units of biological activity of XEOMIN cannot be compared to or converted into units of any other botulinum toxin products.
- Hypersensitivity reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur further injection of XEOMIN should be discontinued and appropriate medical therapy immediately instituted.
- Treatment with XEOMIN and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant effects occur, additional respiratory muscles may be involved [See Boxed Warning]. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. These reactions can occur within hours to weeks after injection with botulinum toxin.
- Cervical Dystonia: Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk of dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia.
- Blepharospasm: Injection of XEOMIN into the orbicularis oculi muscle may lead to reduced blinking and corneal exposure with possible ulceration or perforation. Lower lid injections should not be repeated if diplopia occurred with previous botulinum toxin injections.
- Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of XEOMIN.
Cervical Dystonia: The most commonly observed adverse reactions (incidence greater than or equal to 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 greater than or equal to 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%).
Concomitant 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 PREGNANCY
Pregnancy 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.
Merz 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, Physiatry, Dermatology, and Podiatry.
With over a century of 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 Merz Pharma GmbH & Co KGaA. Botox is a registered trademark of Allergan, Inc.
SOURCE Merz Pharmaceuticals, LLC
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