RALEIGH, N.C.--(BUSINESS WIRE)--Merz today announced long-term results from a Phase 3 extension study of XEOMIN® (incobotulinumtoxinA) for the treatment of adults with chronic sialorrhea, also known as excessive drooling. Results were presented at the American Academy of Physical Medicine and Rehabilitation (AAPM&R) Annual Assembly being held October 25-28 in Orlando, FL.
In the randomized, placebo-controlled initial 16-week main period followed by a 48-week extension period, subjects who received XEOMIN demonstrated sustained improvements in unstimulated salivary flow rate (uSFR) across treatment cycles and increasing improvements in clinical outcomes and quality of life with repeated injection cycles. Overall results showed that safety and tolerability of XEOMIN was consistent across both study periods, and no new or unexpected adverse events were reported.
“The results from this pivotal extension period are significant for patients with neurological disorders, who often face a number of physical and psychosocial challenges due to chronic sialorrhea,” said Dr. Kristina Yu-Isenberg, Vice President, North America Medical Affairs at Merz. “We are pleased to share data confirming XEOMIN is safe and effective for long-term use in sialorrhea, as this can be a life-long challenge that patients and their physicians need to effectively manage to optimize outcomes.”
In July 2018, the U.S. Food and Drug Administration approved XEOMIN for the treatment of chronic sialorrhea in adult patients based on the pivotal study’s primary endpoint for the 16-week main period. XEOMIN is the first and only neurotoxin with this approved indication in the United States.
“We are pleased to offer the first and only neurotoxin for the estimated 600,000 adult patients living with chronic sialorrhea in the U.S.,” said Kevin O’Brien, Vice President and Head of U.S. Neurosciences, Merz. “This extension period, along with the two pooled safety analyses being presented reinforces the overall safety profile of XEOMIN in all of our indications, and further demonstrates our commitment to helping people living with movement disorders.”
SIAXI (Sialorrhea In Adults XEOMIN® Investigation) was a Phase 3, prospective, randomized, double-blind, placebo-controlled trial that investigated the efficacy and safety of XEOMIN for the treatment of excessive drooling (or sialorrhea).
In addition to the XEOMIN extension data being presented, Merz will be presenting two pooled safety analyses reinforcing the overall safety profile of XEOMIN in all of our indications:
- Pooled Safety Analysis of Randomized, Prospective Studies on IncobotulinumtoxinA for the Treatment of Cervical Dystonia, Blepharospasm, and Upper Limb Spasticity
- Safety of IncobotulinumtoxinA in Adult Spasticity: Results from a Pooled Analysis of Randomized, Prospective, Clinical Studies
About Merz Neurosciences
Merz Neurosciences is a division of Merz North America and is deeply committed to offering novel therapeutic options that address the largely unmet medical needs that exist within the area of neuroscience. Merz Neurosciences is an important contributor to the U.S. neurosciences space and offers a portfolio that includes the neurotoxin XEOMIN® (incobotulinumtoxinA), the anticholinergic Cuvposa® (glycopyrrolate) Oral Solution and the Prolaryn® injectable implant family of products. To learn more about Merz Neurosciences and its U.S. product portfolio, please visit www.merzusa.com/neurosciences.
About Merz North America, Inc.
Merz North America, Inc. is a specialty healthcare company dedicated to the development and marketing of innovative quality products for physicians and patients across the United States and Canada. Merz products are distributed through two divisions, Aesthetics and Neurosciences, and are developed with the goal of improving patients’ health and quality of life by delivering therapies that bring about real progress. Privately-held, Merz North America is headquartered in Raleigh, North Carolina. To learn more about Merz North America, Inc., please visit www.merzusa.com.
About XEOMIN® (incobotulinumtoxinA)
XEOMIN® (incobotulinumtoxinA) is a prescription medicine that is injected into muscles or glands and used to treat adults with sialorrhea, increased muscle stiffness in the arm of adults with upper limb spasticity, the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults, and to treat abnormal spasm of the eyelids (blepharospasm) in adults who have had prior treatment with onabotulinumtoxinA (Botox®).
PLEASE SEE BELOW FOR THE IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
XEOMIN® (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use, is a prescription medicine that is used to treat adults with:
- chronic sialorrhea
- upper limb spasticity
- cervical dystonia
- blepharospasm who were previously treated with onabotulinumtoxinA (BOTOX®)
IMPORTANT SAFETY INFORMATION
WARNING: DISTANT SPREAD OF TOXIN EFFECT
See full prescribing information for complete BOXED WARNING.
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 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, particularly in those patients who have underlying conditions that would predispose them to these symptoms.
- 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. XEOMIN is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
- Use in patients with an infection at the injection site could lead to severe local or disseminated infection. XEOMIN is contraindicated in the presence of infection at the proposed injection site(s).
WARNINGS AND PRECAUTIONS
- The potency units of XEOMIN are specific to the preparation and assay method used and 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.
- 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. When distant effects occur, additional respiratory muscles may be involved. Patients may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders. Dysphagia may persist for several months, which may require use of a feeding tube. Aspiration may result from severe dysphagia [See BOXED WARNING].
- 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: Treatment with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been post-marketing reports of serious breathing difficulties, including respiratory failure, in patients with cervical dystonia treated with botulinum toxin products. 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.
- XEOMIN contains human serum albumin. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and Creutzfeldt-Jakob disease (CJD). No cases of transmission of viral diseases or CJD have ever been reported for albumin.
Chronic Sialorrhea: The most commonly observed adverse reactions (incidence ≥3% of patients and greater than placebo) for XEOMIN were tooth extraction (5%), dry mouth (4%), diarrhea (4%), hypertension (4%), fall (3%), bronchitis (3%), dysphonia (3%), back pain (3%) and dry eye (3%).
Upper Limb Spasticity: The most commonly observed adverse reactions (incidence ≥2% of patients and greater than placebo) for XEOMIN were seizure (3%), nasopharyngitis (2%), dry mouth (2%), and upper respiratory tract infection (2%).
Cervical Dystonia: The most commonly observed adverse reactions (incidence ≥5% of patients and greater than placebo) for XEOMIN 120 Units and XEOMIN 240 Units, respectively, were: dysphagia (13%, 18%), injection pain site (9%, 4%), neck pain (7%, 15%), muscle weakness (7%, 11%), and musculoskeletal pain (7%, 4%).
Blepharospasm: The most commonly observed adverse reactions (incidence ≥5% of patients and twice greater than placebo) for XEOMIN were eyelid ptosis (19%), dry mouth (16%), dry eye (16%), visual impairment (12%), diarrhea (8%), headache (7%), dyspnea (5%) and nasopharyngitis (5%).
Co-administration of XEOMIN and aminoglycoside antibiotics or other agents interfering with neuromuscular transmission, e.g., tubocurarine-type muscle relaxants, should only be performed with caution as these agents may potentiate the effect of the toxin.
Use of anticholinergic drugs after administration of XEOMIN may potentiate systemic anticholinergic effects. The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
USE IN PREGNANCY
There are no adequate data on the developmental risk associated with the use of XEOMIN in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established.
Copyright © 2018 Merz North America, Inc. All rights reserved. MERZ, the MERZ logo, and XEOMIN are registered trademarks of Merz Pharma GmbH & Co. KGaA. CUVPOSA is a registered trademark of Merz Pharmaceuticals, LLC. PROLARYN GEL and PROLARYN PLUS are trademarks of Merz North America, Inc. BOTOX is a registered trademark of Allergan, Inc.