Merz Snags FDA Approval for Chronic Drooling Treatment
North Carolina-based Merz Neurosciences announced late Tuesday that the U.S. Food and Drug Administration approved the supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA), a treatment for chronic drooling in adults with neurodegenerative diseases.
Xeomin is the first and only neurotoxin approved for the condition known as chronic sialorrhea, the company said. The FDA quickly approved Xeomin under priority review. Merz submitted its sBLA in March and the FDA initially gave the company an indication it would make its decision by the end of the fourth quarter of 2018.
When it was initially submitted to the FDA, David Dabrowski, head of R&D at Merz, said that the medication would be a boon for both patients and caregivers. He noted that sialorrhea is a common problem among people living with neurological disorders and added that the results of the excessive drooling can add both physical and psychological challenges for both patient and caregiver.
Chronic sialorrhea is the fourth indication for which the FDA has approved Xeomin. It was originally approved in 2010 for the treatment of cervical dystonia and blepharospasm. In 2015 the FDA approved Xeomin for upper limb spasticity in adult patients. Now the medication can be used to treat those patients who have developed excessive drooling as a result of other neurodegenerative diseases, such as Parkinson’s disease, amyotrophic lateral sclerosis (ALS), cerebral palsy or Alzheimer’s disease. The condition typically occurs from problems controlling facial muscles and results in difficulty retaining saliva inside the mouth, issues with swallowing.
Kevin O’Brien, head of Merz North America’s neuroscience business, said the approval of Xeomin for this indication is significant for patients.
“Until now, there has not been an FDA approved treatment for this debilitating condition. This approval represents a significant milestone in addressing the unmet needs for more than 600,000 adults who suffer from chronic sialorrhea, and underscores our commitment to improving the lives of those living with movement disorders,” O’Brien, who spent 16 years at Allergan, said in a statement.
The FDA approved Xeomin for chronic sialorrhea based on Phase III results that showed the neurotoxin hit its co-primary endpoints. A statistically significant improvement was observed in change in unstimulated salivary flow rate (uSFR) and Global Impression of Change Scale (GICS), both at week four as compared to pre-injection baseline. The trial involved 184 patients.
In addition to Xeomin, Merz has several treatments in its neurological arsenal, including the anticholinergic Cuvposa (glycopyrrolate) Oral Solution and the Prolaryn injectable implant family of products.