General Information

Cuvposa (glycopyrrolate) is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including salivary glands. Glycopyrrolate indirectly reduces the rate of salivation by preventing the stimulation of these receptors.

Cuvposa is specifically indicated to reduce chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling.

Cuvposa is supplied as a liquid solution for oral administration. The recommended initial dose is 0.02 mg/kg orally three times daily. The dosing may be titrated in increments of 0.02 mg/kg every 5-7 days based on therapeutic response and adverse reactions. The maximum recommended dosage is 0.1 mg/kg three times daily not to exceed 1.5-3 mg per dose based upon weight.

Mechanism of Action

Cuvposa (glycopyrrolate) is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including salivary glands. Glycopyrrolate indirectly reduces the rate of salivation by preventing the stimulation of these receptors.

Side Effects

Adverse events associated with the use of Cuvposa may include, but are not limited to, the following:

• Dry mouth
• Vomiting
• Constipation
• Flushing
• Nasal congestion

Clinical Trial Results

The FDA approval of Cuvposa was based on a multi-center, randomized, double-blind, placebo-controlled, parallel, eight-week study in 38 subjects aged 3-23 years. Of these 38 subjects, 36 were ages were ages 2 - 16 years and two subjects were older than 16 years. All subjects had a diagnosis of cerebral palsy, mental retardation, or another neurologic condition associated with problem drooling, defined as drooling in the absence of treatment so that clothing became damp on most days (approximately five to seven days per week). The subjects received receive Cuvposa or placebo. Doses of Cuvposa were titrated over a 4-week period to optimal response beginning at 0.02 mg/kg given three times a day increasing doses in increments of approximately 0.02 mg/kg three times per day every 5-7 days, not to exceed the lesser of approximately 0.1 mg/kg three times per day or 3 mg three times per day. Efficacy was evaluated on the 9-point modified Teacher's Drooling Scale (mTDS). Scores were recorded by parents/caregivers three times daily approximately two hours post-dose on beginning at pre-treatment baseline and at Weeks 2, 4, 6 and 8 of therapy. A score of 1 meant Dry: never drools and a score of 9 meant Profuse: clothing, hands, tray and objects become wet; frequently. Responders were defined as subjects with at least a 3-point reduction in mean daily mTDS scores from baseline to Week 8. In the Cuvposa treatment arm, 75% of the patients were responders versus 11% in the placebo arm.