​Merz Neurosciences, a division of Raleigh-based Merz North America, has reported positive results from a Phase 3 clinical trial of its drug Xeomin for the treatment of adult sialorrhea, or unwanted drooling, due to Parkinson’s disease and other neurologic disorders.

“The findings from this well-controlled Phase 3 clinical study are a step towards providing a therapeutic option for adult patients with sialorrhea, a condition in which patients’ 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 four months after the initial injection.”

The trial results were reported at the 21st International Congress of Parkinson’s Disease and Movement Disorders in Vancouver, British Columbia.

Xeomin, or incobotulinumtoxinA, is a prescription neurotoxin that is injected into muscles to treat stiffness in the arm of adults with upper limb spasticity, the abnormal head position and neck pain that accompanies cervical dystonia in adults, and abnormal spasm of the eyelids in adults who have had prior treatment with Botox.

In the trial for the treatment of drooling, Xeomin was tested on 184 patients in a placebo-controlled, randomized trial. Following the initial 16-week main period of the trial, patients receiving injections of the drug in their salivary glands versus placebo had an improved unstimulated salivary flow rate and better Global Impression of Change Scale (GICS) score at four weeks. GICS is a commonly used rating system for treatments of neurological disorders by clinicians.

“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,” said David Dobrowski, vice president of research and development at Merz North America. “We look forward to discussing these data with the FDA as progress towards a future marketing application.”

Merz North America is a specialty healthcare company that develops and commercializes treatments in aesthetics, dermatology and neurosciences in the U.S. and Canada. In addition to its Raleigh headquarters, which employs about 250 people, the company also has locations in Mesa, Ariz., Franksville, Wis., and Toronto.

Merz North America is the largest subsidiary of Merz Pharma Group, a family-owned pharmaceutical company founded in 1908 and headquartered in Frankfurt, Germany.

Globally, Merz is focused on medications for neurological and psychiatric illnesses and developed the first drug for the treatment of moderate to severe stages of Alzheimer’s disease. That drug, a cognition-enhancing compound known as memantine, is now marketed under the brand names Namenda, Auxura, Ebixa and Memary among others.

Merz Pharma Group has about 3,000 employees and 34 subsidiaries worldwide, according to its website. It reported revenues of 1.09 billion Euros in the 2015-16 fiscal year.

(C) N.C. Biotechnology Center