GREENSBORO, N.C., Oct. 25, 2011 /PRNewswire/ -- Merz Pharmaceuticals, LLC, today announced that data from studies evaluating the dosing and adverse event profiles of Xeomin® (incobotulinumtoxinA), a botulinum toxin type A free from accessory proteins, in the treatment of blepharospasm (eyelid spasms) will be presented at the 115th Annual Meeting of the American Association of Ophthalmology (AAO) in Orlando, Fla.
These data include an extension of the Phase III, randomized, placebo-controlled, double-blind trial that assessed the safety and efficacy of XEOMIN in blepharospasm, which was recently published in the July 2011 issue of Movement Disorders, the official journal of the Movement Disorders Society. Findings from the Phase III trial demonstrate that XEOMIN was significantly more efficacious than placebo, as observed in the primary efficacy variable (change in Jankovic Rating Scale severity subscore six weeks following treatment), when administered in a single treatment session to patients with blepharospasm who were previously treated with onabotulinumtoxinA (Botox®).
Blepharospasm, also referred to as benign essential blepharospasm, is a rare condition that possibly goes undiagnosed or misdiagnosed.Botulinum toxin is the only FDA-approved medication for the treatment of this condition.The U.S. Food and Drug Administration (FDA) approved XEOMIN in July 2010 for the treatment of blepharospasm in adults who have been previously treated with Botox®.
"XEOMIN studies led to clinically relevant reductions in the severity of symptoms such as excessive blinking and eyelid spasms," said lead author of the Movement Disorders publication Joseph Jankovic, MD, Professor of Neurology and Director of the Parkinson's Disease Center and Movement Disorders Clinic, Baylor College of Medicine, Houston, Texas. "The results demonstrate the safety and efficacy of XEOMIN for the treatment of blepharospasm, a neurological condition that, if untreated, can cause significant disability."
The first poster presented at the AAO meeting, titled "Dosing Profile of XEOMIN (incobotulinumtoxinA) During Long-Term, Open-Label Treatment of Benign Essential Blepharospasm," evaluated the repeat-dosing profile of XEOMIN for up to 48 weeks, including the inter-injection interval, during an open-label extension (OLEX) of the Phase III randomized, double-blind trial that evaluated XEOMIN versus placebo. Although the injection frequency varied during the OLEX and many participants received injections at less than 12-week intervals, the investigator-determined dosing profile of XEOMIN remained similar to the initial single-treatment study, which was based on prior treatment with Botox®. [PO440, Oct. 24, 2011, 2 3:30 p.m. ET, Hall A1]
The second poster presented at the AAO meeting, titled "Adverse Event (AE) Profile of XEOMIN (incobotulinumtoxinA) in the Benign Essential Blepharospasm (BEB) Clinical Trials Program," assessed the AE profile of XEOMIN across two single-treatment trials (one versus placebo and one versus Botox®), as well as one repeat-treatment study (OLEX of the Phase III placebo-controlled study). [PO441, Oct. 24, 2011, 2 3:30 p.m. ET, Hall A1]
"Our community is always interested in learning more about XEOMIN and we are pleased to see these important data published in a prestigious journal and presented at the American Academy of Ophthalmology meeting. Merz has taken a strong interest in the blepharospasm community and the Company's commitment to educational programming is welcomed by the Benign Essential Blepharospasm Research Foundation," said Mary Lou (Koster) Thompson, BEBRF President.
About The Phase III Placebo-controlled Study and OLEX
The Phase III, randomized, placebo-controlled, double-blind study published in the journal Movement Disorders evaluated blepharospasm patients between 18 and 80 years of age at 34 sites in the U.S. and Canada, from October 2006 to May 2008. Eligible patients (n=109) were randomized in a 2:1 ratio to receive XEOMIN or placebo and were followed up to 20 weeks. The selection of doses, dilution, volume and injection sites for treatment was based on the last two Botox® treatments (+/- 10%) prior to the start of the study. Up to 50 Units per eye was allowed.
At each visit, the severity and frequency of blepharospasm symptoms were assessed by the Jankovic Rating Scale (JRS), and the Blepharospasm Disability Index (BSDI) was used to evaluate the effect of XEOMIN on patients' functional impairment. The BSDI evaluates six specific activity items, including watching TV, shopping, walking, reading, driving a vehicle and doing everyday activities. In addition, JRS scores were determined by daily patient self-assessments.
A significant difference was observed in the primary efficacy variable (change in JRS severity subscore rated by an independent rater six weeks following treatment), favoring XEOMIN by 1.0 point (P<.001). No patients discontinued the study prematurely because of insufficient treatment efficacy or adverse events.
All patients who completed the placebo-controlled trial (n=102) were eligible to enter the OLEX, which involved repeat treatment with XEOMIN (up to five treatment sessions) over a period of up to 48 weeks. Investigators determined dosing (up to 50 Units per eye) and frequency of injections, with at least six weeks between sessions.
In nature, Clostridium botulinum produces botulinum toxin in association with ancillary accessory 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 removes accessory proteins.
More than 250,000patients 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.
Financial Assistance and Reimbursement Support Services
Merz offers two comprehensive programs to provide patients with financial assistance for XEOMIN. The XEOMIN Patient Co-payment Program is easy-to-use and offers eligible patients, who are appropriate for treatment with XEOMIN as determined by their physician, assistance for their actual out-of-pocket costs for treatment with XEOMIN. To be eligible, patients must be at least 18 years of age, currently have commercial health insurance that covers treatment costs for XEOMIN, not be enrolled in or eligible for Medicare, Medicare Advantage, Medicaid, Managed Medicaid, TRICARE (i.e., CHAMPUS), or other state or federally funded insurance plan, and not be a resident in the state of Massachusetts. Eligible treatment-related costs may include the cost of XEOMIN, associated guidance therapy and related administration fees.
The XEOMIN Patient Assistance Program provides XEOMIN at no cost to eligible patients who are experiencing financial hardship, do not have third-party drug coverage, and who are not eligible for government-funded drug programs.
For more information about reimbursement support and financial assistance programs for XEOMIN, visit www.XEOMIN.com, or call 1-888-4-XEOMIN (1-888-493-6646). Dedicated support representatives are available from 8 a.m. until 8 p.m. (EDT), Monday through Friday.
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
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