Merz North America announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (sBLA) for Xeomin® (incobotulinumtoxinA) for the treatment of chronic sialorrhea (excessive drooling) due to Parkinson’s Disease or other neurologic disorders in adult patients. The sBLA is based on a Phase III study, which met both of its co-primary endpoints for subjects administered 100 U incobotulinumtoxinA by achieving statistically significant change in unstimulated salivary flow rate (uSFR), and in the subjects’ Global Impression of Change Scale (GICS). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in Q4 2018, and if approved, has the potential to make Xeomin the first neurotoxin with this indication in the U.S.
"Sialorrhea is a common problem among people living with neurological disorders, causing added physical and psychosocial challenges for patients as well as caregivers," said David Dobrowski, Vice President of Research and Development, Merz North America. "We believe Xeomin can help manage excessive drooling, and we look forward to continuing to work closely with the FDA as they review our application."
The sBLA is based on a Phase III, randomized, double-blind, placebo-controlled, multicenter 184 subject trial. Both co-primary endpoints were successfully achieved. A statistically significant improvement was observed in change in uSFR at week four as compared to baseline pre-injection, for subjects administered 100 U incobotulinumtoxinA vs. placebo, and in the subjects’ GICS at week four for subjects administered 100 U incobotulinumtoxinA vs. placebo (p=0.004 and p=0.002, respectively). GICS is a commonly used rating system for treatments of neurological disorders by clinicians. Overall frequency of adverse events was similar between placebo and treatment groups with no new or unexpected adverse events reported. Subjects enrolled in the study received placebo (n=36), incobotulinumtoxinA 75 U (n=74), or incobotulinumtoxinA 100 U (n=74).
Results of the study were presented at last year’s International Congress of Parkinson’s Disease and Movement Disorders (MDS), American Academy of Physical Medicine and Rehabilitation (AAPM&R) and American Congress of Rehabilitation Medicine (ACRM) annual meetings.
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.
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.
About XEOMIN® (incobotulinumtoxinA)
Xeomin® (incobotulinumtoxinA) is a prescription medicine that is injected into muscles and used to treat 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®).
XEOMIN® IMPORTANT CONSUMER SAFETY INFORMATION
Read the Medication Guide before you start receiving XEOMIN® (Zeo-min) and each time XEOMIN® is given to you as there may be new information. The risk information provided here is not comprehensive.
Uses
XEOMIN® is a prescription medicine that is injected into muscles and used to treat:
- increased muscle ...
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