RALEIGH, NC, USA I June 7, 2017 I Merz Neurosciences, a division of Merz North America, announced today positive topline results from its pivotal Phase III clinical trial of Xeomin® (incobotulinumtoxinA) for the treatment of adult sialorrhea, or unwanted drooling, due to Parkinson’s Disease and other neurologic disorders during the 21st International Congress of Parkinson’s Disease and Movement Disorders (MDS) in Vancouver, BC.
Following the initial 16 week main period of the Phase III, placebo-controlled, randomized, 184 patient trial, both co-primary endpoints were successfully achieved with statistically significant improvement observed in change in unstimulated salivary flow rate (uSFR) and in the patients’ Global Impression of Change Scale (GICS) at week four for patients administered 100U incobotulinumtoxinA as compared to baseline pre-injection 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. Patients enrolled in the study received placebo (n=36), incobotulinumtoxinA 75 U (n=74), or incobotulinumtoxinA 100 U (n=74).
“The findings from this well-controlled Phase III clinical study are a step towards providing a therapeutic option for adult patients with sialorrhea, a condition in which patient’s needs are not yet being met,” said Andrew Blitzer, M.D., D.D.S., coordinating investigator and Professor of Clinical Otolaryngology at Columbia University College of Physicians and Surgeons. “Drooling is a burden to both patients and their caregivers. Importantly, the study results demonstrate a duration of efficacy and benefit beyond 4 months after the initial injection.”
Results of the study have been accepted by MDS in the Late-Breaking & Study Group Abstract Session.
“We are excited to have achieved these results through the largest controlled study of incobotulinumtoxinA in the treatment of sialorrhea due to Parkinson’s disease and other neurological conditions,” added David Dobrowski, Vice-President of Research and Development, Merz North America, Inc. “We look forward to discussing these data with the FDA as progress towards a future marketing application.”
SIAXI (Sialorrhea In Adults Xeomin® Investigation) is a prospective, randomized, double-blind, placebo-controlled, Phase 3 trial (NCT02091739) to investigate efficacy and safety of incobotulinumtoxinA for the treatment of unintended drooling, called sialorrhea, in Parkinson’s disease (PD) and other neurological conditions. Participants were adults (n=184) with chronic, troublesome sialorrhea related to PD, atypical Parkinson syndromes, stroke, or traumatic brain injury. In the 16-week double-blind main period, subjects received a single treatment with total incobotulinumtoxinA doses of 75 U or 100 U or placebo administered in four injections into bilateral parotid and bilateral submandibular salivary glands.
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 their U.S. product portfolio, please visit www.merzusa.com/neurosciences. For more information about Merz Neurosciences and their U.S. product portfolio, please visit www.merzusa.com.
About Merz North America
Merz North America 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. Merz North America is a privately-held company based in Raleigh, North Carolina. To learn more about Merz North America, please visit www.merzusa.com.
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®).
SOURCE: Merz Neurosciences
Post Views: 29
RALEIGH, NC, USA I June 7, 2017 I Merz Neurosciences, a division of Merz North America, announced today positive topline results from its pivotal Phase III clinical trial of Xeomin® (incobotulinumtoxinA) for the treatment of adult sialorrhea, or unwanted drooling, due to Parkinson’s Disease and other neurologic disorders during the 21st International Congress of Parkinson’s Disease and Movement Disorders (MDS) in Vancouver, BC.
Following the initial 16 week main period of the Phase III, placebo-controlled, randomized, 184 patient trial, both co-primary endpoints were successfully achieved with statistically significant improvement observed in change in unstimulated salivary flow rate (uSFR) and in the patients’ Global Impression of Change Scale (GICS) at week four for patients administered 100U incobotulinumtoxinA as compared to baseline pre-injection 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. Patients enrolled in the study received placebo (n=36), incobotulinumtoxinA 75 U (n=74), or incobotulinumtoxinA 100 U (n=74).
“The findings from this well-controlled Phase III clinical study are a step towards providing a therapeutic option for adult patients with sialorrhea, a condition in which patient’s needs are not yet being met,” said Andrew Blitzer, M.D., D.D.S., coordinating investigator and Professor of Clinical Otolaryngology at Columbia University College of Physicians and Surgeons. “Drooling is a burden to both patients and their caregivers. Importantly, the study results demonstrate a duration of efficacy and benefit beyond 4 months after the initial injection.”
Results of the study have been accepted by MDS in the Late-Breaking & Study Group Abstract Session.
“We are excited to have achieved these results through the largest controlled study of incobotulinumtoxinA in the treatment of sialorrhea due to Parkinson’s disease and other neurological conditions,” added David Dobrowski, Vice-President of Research and Development, Merz North America, Inc. “We look forward to discussing these data with the FDA as progress towards a future marketing application.”
SIAXI (Sialorrhea In Adults Xeomin® Investigation) is a prospective, randomized, double-blind, placebo-controlled, Phase 3 trial (NCT02091739) to investigate efficacy and safety of incobotulinumtoxinA for the treatment of unintended drooling, called sialorrhea, in Parkinson’s disease (PD) and other neurological conditions. Participants were adults (n=184) with chronic, troublesome sialorrhea related to PD, atypical Parkinson syndromes, stroke, or traumatic brain injury. In the 16-week double-blind main period, subjects received a single treatment with total incobotulinumtoxinA doses of 75 U or 100 U or placebo administered in four injections into bilateral parotid and bilateral submandibular salivary glands.
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 their U.S. product portfolio, please visit www.merzusa.com/neurosciences. For more information about Merz Neurosciences and their U.S. product portfolio, please visit www.merzusa.com.
About Merz North America
Merz North America 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. Merz North America is a privately-held company based in Raleigh, North Carolina. To learn more about Merz North America, please visit www.merzusa.com.
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®).
SOURCE: Merz Neurosciences
Post Views: 29
