FDA Approves Glycopyrrolate Oral Solution for Chronic Severe Drooling

Yael Waknine

July 29, 2010

July 29, 2010 — The US Food and Drug Administration (FDA) has approved glycopyrrolate oral solution (Cuvposa; Shionogi Pharma, Inc) for the treatment of patients aged 3 to 16 years with chronic severe drooling associated with neurologic conditions, such as cerebral palsy.

The action provides patients and caregivers with the first liquid medication indicated to reduce chronic severe drooling. Until now, glycopyrrolate tablets have been crushed for off-label use, having been approved decades ago to treat peptic ulcers and reduce salivation under anesthesia.

"FDA approval not only ensures that the product meets modern standards for safety, effectiveness, quality and labeling; but, also results in a more suitable dose form for this patient population," notes John Jenkins, MD, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, in an agency news release. Easier to administer, the 1 mg/5 mL cherry-flavored glycopyrrolate oral solution also provides the optimal dose for each patient.

Product approval was based on clinical trial data showing that 78% of children and adolescents treated with glycopyrrolate oral solution achieved clinical improvements in drooling compared with 11% of those given placebo.

Treatment-related adverse events most commonly included dry mouth, vomiting, constipation, flushing, urinary retention, and nasal congestion.

Patients should be assessed for abdominal distension, pain, nausea, and vomiting within 4 to 5 days of initial dosing and dose increases. Incomplete mechanical intestinal obstruction may present as diarrhea; if obstruction is suspected, glycopyrrolate should be withheld pending patient evaluation.

Glycopyrrolate should not be used in patients with medical conditions that preclude anticholinergic therapy and those taking potassium chloride pills. Caution is advised in patients with renal impairment. Patients should be warned to avoid high temperatures because of the risk for heat prostration.

Concomitant use of glycopyrrolate can increase serum levels of digoxin, atenolol, and metformin; alternative dosage forms of digoxin should be considered and dose reductions are advised for atenolol and metformin. Serum levels of haloperidol or levodopa may be decreased, necessitating dose increases.

Because concurrent use of amantadine may increase glycopyrrolate effects, dose reductions for glycopyrrolate should be considered during concomitant use.

Glycopyrrolate previously was granted orphan drug status by the FDA.

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