The US FDA approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years. Shionogi Pharma of Japan markets Cuvposa Oral Solution.

Glycopyrrolate was approved decades ago to treat peptic ulcers and reduce salivation in patients under anesthesia. Until now, glycopyrrolate has been used on an off-label basis to treat drooling in the developmentally disabled population, but in a different dosage form than the approved product. Cuvposa is a flavored oral solution that is easier to administer and provides the optimal dose for each patient.

In clinical trials of Cuvposa glycopyrrolate oral solution, 78 percent of the children on the drug reached clinical improvement in drooling compared with 19 percent of those given an inactive substance. Common adverse reactions reported with glycopyrrolate are dry mouth, constipation, flushing, and urinary retention.

Drooling is normal in infants. However, a significant proportion of the developmentally disabled population experiences drooling caused primarily by neuromuscular dysfunction that makes it hard to swallow. Cuvposa reduces drooling by lowering the volume of saliva produced.