GREENSBORO, N.C., March 8, 2011 /PRNewswire/ -- Merz Pharmaceuticals today announced the launch of two programs to provide financial assistance to patients for their treatment with Xeomin® (incobotulinumtoxinA). XEOMIN is a botulinum toxin type A free from accessory proteins that is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with cervical dystonia, to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naive and previously treated patients. XEOMIN is also approved for the treatment of adults with blepharospasm who were previously treated with onabotulinumtoxinA (Botox®).
The XEOMIN Patient Co-payment Program is easy-to-use and offers eligible patients assistance for their actual out-of-pocket costs for therapeutic treatment with XEOMIN. Eligible treatment-related costs may include the cost of XEOMIN, associated guidance therapy and related administration fees.
Merz also announced the launch of the XEOMIN Patient Assistance Program, a program to provide XEOMIN at no cost to eligible patients who are experiencing financial hardship and who do not have third party drug coverage.
Enrollment in the XEOMIN Patient Co-payment Program or the XEOMIN Patient Assistance Program is simple. Patients who want to learn more about the programs and secure an application form can do so by calling 1-888-4-XEOMIN (1-888-493-6646) or by speaking with their healthcare provider. Dedicated support representatives are available from 8 a.m. until 8 p.m. (EST), Monday through Friday.
"By offering a continuum of XEOMIN financial assistance programs, our hope is to help patients manage their cervical dystonia and blepharospasm costs by reducing or eliminating financial obstacles that may prevent initiation or continuation of treatment," said Jack Britts, President and CEO of Merz Pharmaceuticals, LLC. "At Merz, we understand how difficult it can be to live with chronic conditions like cervical dystonia and blepharospasm, and we are committed to helping people regardless of their financial or healthcare coverage status. We designed our assistance programs to be easy to navigate and to help alleviate patients' financial burdens for their XEOMIN treatment costs."
Dystonias are movement disorders in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. These movements, which are involuntary and sometimes painful, may affect a single muscle (focal), a group of muscles such as those in the arms, legs, or neck (segmental), or even the entire body (generalized). Symptoms can be mild or severe and dystonias may be markedly disabling.
Although dystonia is thought to be rare, it is possibly undiagnosed or misdiagnosed due to lack of specific clinical criteria. While focal dystonia, such as blepharospasm or cervical dystonia can affect people at any age, most people first experience symptoms in middle age.
According to an epidemiology study conducted in Rochester, Minn., focal dystonia (which includes cervical dystonia, and may be characterized by twisting of the neck, and blepharospasm, or excessive eyelid spasm)is estimated to affect 295 per million people in the U.S.
In nature, Clostridium botulinum produces the toxin in association with ancillary accessory proteins. 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.
More than 84,000 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 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.
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, 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 Merz Pharma GmbH & Co KGaA.
Botox® is a registered trademark of Allergan, Inc.
SOURCE Merz Pharmaceuticals