Sialorrhea is defined as drooling or excessive salivation as a result of limitations in a person’s ability to control and swallow oral secretions.1 It is a common problem in children or adults with neurological conditions such as cerebral palsy, Parkinson’s disease, mental retardation, and amyotrophic lateral sclerosis (ALS).2, 3, 4 Sialorrhea can lead to significant physical or psychosocial complications that can create an additional burden to these medically complicated patients.5
Current treatments for sialorrhea include anticholinergic agents that are associated with treatment-limiting adverse events and require titration and dosing up to three times per day.1 Neos is evaluating NT0502, a new chemical entity and selective muscarinic antagonist, as a potential treatment for this condition.
Neos believes that NT0502 may be a viable treatment option that will utilize the same proprietary microparticle delivery technology used in our four approved products. Investigational New Drug (IND)-enabling studies are ongoing, and Neos anticipates initiating a Phase 1 clinical trial in the first half of 2020.
NT0502 in Development for the Treatment of Sialorrhea
- New chemical entity but active metabolite of oxybutynin
- Anticholinergic agent that is thought to be preferentially selective for blocking muscarinic receptor subtypes predominant in salivary glands
- Formulated with Neos microparticle technology for once- or twice-daily dosing
- Hockstein NG et. al. Sialorrhea: a management challenge. Am Fam Physician 2004; 69:2628-34.
- Squires N et al. The management of drooling in adults with neurological conditions. Curr Opin Otolaryngol Head Neck Surg 2012; 20(3):171-6
- Boyce HW and Bakheet MR. Sialorrhea: a review of a vexing, often unrecognized sign of oropharyngeal and esophageal disease. J Clin Gastroenterol 2015; 39(2): 89-97.
- Banfi P et al. A review of options for treating sialorrhea in amyotrophic lateral sclerosis. Respir Care 2015;60(3):446-454.
- Glader L, et al. Sialorrhea: Bottom line ‘evidence-informed’ recommendations for children/youth with Cerebral palsy who have sialorrhea. AACPDM Care Pathways 2016.