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CUVPOSA (glycopyrrolate) an FDA-approved treatment indicated to reduce Chronic Severe Drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling (eg, cerebral palsy).1


Liquid formulation: designed with purpose

Liquid formulation icon

Convenient for your patient

Helps ensure that your patient receives the intended dose.*

*Use an accurate dose-measuring cup to get the right dose of CUVPOSA.1

Convenient cup icon

Convenient for your caregiver

No mixing or pill crushing. No more asking your patient to finish their food so they receive the proper dose.

†Give CUVPOSA at least 1 hour before or 2 hours after meals.1

Oral syringe icon

Convenient for you

Easy to titrate based on your patient's needs to deliver an individualized dose.


Study design1

CUVPOSA was evaluated in a multi-center, randomized, double-blind, placebo-controlled, parallel, eight-week study for the control of pathologic drooling in children (Study 1). The study enrolled 38 subjects aged 3-23 years; thirty-six subjects were aged 3-16 years and two patients were greater than 16 years.

The subjects were male or female, weighed at least 13 kg (27 lbs), and had 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).

Subjects were randomized in a 1:1 fashion to receive CUVPOSA or placebo. Doses of study medication were titrated over a 4-week period to optimal response beginning at 0.02 mg/kg 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.

Significant reduction in drooling1

CUVPOSA® was tested in a clinical trial. At the end of this study—8 weeks after starting treatment—75% of patients who were given CUVPOSA saw a reduction in drooling. Only 11% of patients who received the placebo saw a reduction after 8 weeks. And patients treated with CUVPOSA also saw some reductions as early as the fourth week of treatment.1

‡In the clinical trial, half the patients, chosen at random, received CUVPOSA; the other half received a placebo (similar-looking and -tasting liquid with no medicine in it). Neither the patients nor the doctors knew who got which until the trial was completed.

75% of patients who were given CUVPOSA® in a clinical study saw a reduction in drooling by week 8.

Measuring the reduction

To measure the amount of drooling before and after treatment, the doctors used the modified Teacher’s Drooling Scale (mTDS). It provides a numerical score based on how often a child drools and how severe it is. The scale goes from 1 to 9. One is the lowest level of drooling; 9 is the highest.1

In this clinical trial, an improvement was defined as at least a 3-point reduction in the drooling scale (eg, the patient started at 7 and ended at 4).

Mean (±2 standard errors) mTDS Scores1

4 week response efficacy chart

Nine-Point mTDS1

  1. Dry: never drools
  2. Mild: only the lips are wet; occasionally
  3. Mild: only the lips are wet; frequently
  4. Moderate: wet on the lips and chin; occasionally
  5. Moderate: wet on the lips and chin; frequently
  6. Severe: drools to the extent that clothing becomes damp; occasionally
  7. Severe: drools to the extent that clothing becomes damp; frequently
  8. Profuse: clothing, hands, tray, and objects become wet; occasionally
  9. Profuse: clothing, hands, tray, and objects become wet; frequently

Safety profile

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a longer, 24 week, open-label study of 137 subjects, the most commonly reported adverse reactions were similar to those seen in the placebo-controlled clinical trial.1


REFERENCE:
  1. CUVPOSA® [package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC, 2021.

INDICATIONS AND USAGE

CUVPOSA (glycopyrrolate) is an anticholinergic oral solution indicated to reduce chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

CUVPOSA is contraindicated in:

  • Patients with medical conditions that preclude anticholinergic therapy (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis).
  • Patients taking solid oral dosage forms of potassium chloride tablets through the gastrointestinal (GI) tract may be arrested or delayed with coadministration of CUVPOSA.

WARNINGS AND PRECAUTIONS

  • Constipation is a common dose-limiting adverse reaction which sometimes leads to glycopyrrolate discontinuation. Assess patients for constipation, particularly within 4-5 days of initial dosing or after a dose increase. Intestinal pseudo-obstruction has been reported and may present as abdominal distention, pain, nausea, or vomiting.
  • Diarrhea may be an early symptom of incomplete mechanical intestinal obstruction, especially in patients with ileostomy or colostomy. If incomplete mechanical intestinal obstruction is suspected, discontinue treatment with CUVPOSA and evaluate for intestinal obstruction.
  • In the presence of high ambient temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as CUVPOSA. Advise patients/caregivers to avoid exposure of the patient to hot or very warm environmental temperatures.
  • CUVPOSA may produce drowsiness or blurred vision. As appropriate for a given age, warn the patient not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking CUVPOSA.
  • Use CUVPOSA with caution in patients with conditions that are exacerbated by anticholinergic drug effects including:
    • Autonomic neuropathy
    • Renal disease
    • Ulcerative colitis – Large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or aggravate “toxic megacolon”, a serious complication of the disease
    • Hyperthyroidism
    • Coronary heart disease, congestive heart failure, cardiac tachyarrhythmia, tachycardia, and hypertension
    • Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition

ADVERSE REACTIONS

The most commonly observed adverse reactions reported by ≥15% of CUVPOSA-treated patients for the placebo-controlled clinical trial were:

  • dry mouth (40%)
  • vomiting (40%)
  • constipation (35%)
  • flushing (30%)
  • nasal congestion (30%)
  • headache (15%)
  • sinusitis (15%)
  • upper respiratory tract infection (15%)
  • urinary retention (15%)

The most commonly observed adverse reactions which occurred at a rate of <2% of CUVPOSA-treated patients in the open label study were:

  • Gastrointestinal: abdominal distension, abdominal pain, stomach discomfort, chapped lips, flatulence, retching, dry tongue
  • General Disorders: irritability, pain
  • Infections: pneumonia, sinusitis, tracheostomy infection, upper respiratory tract infection, urinary tract infection
  • Investigations: heart rate increase
  • Metabolism and Nutrition: dehydration
  • Nervous System: headache, convulsion, dysgeusia, nystagmus
  • Psychiatric: agitation, restlessness, abnormal behavior, aggression, crying, impulse control disorder, moaning, mood altered
  • Respiratory: increased viscosity of bronchial secretion, nasal congestion, nasal dryness
  • Skin: dry skin, pruritus, rash
  • Vascular: pallor

Additional adverse reactions identified during post approval use of glycopyrrolate tablets include: loss of taste and suppression of lactation.

DRUG INTERACTIONS

Drugs Affected by Reduced GI Transit Time

Glycopyrrolate reduces GI transit time, which may result in altered release of certain drugs when formulated in delayed- or controlled-release dosage forms.

  • The passage of potassium chloride tablets through the GI tract may be arrested or delayed with coadministration of glycopyrrolate. Solid dosage forms of potassium chloride are contraindicated.
  • Digoxin administered as slow dissolution oral tablets may have increased serum levels and enhanced action when administered with glycopyrrolate. Monitor patients receiving slow dissolution digoxin for increased action if glycopyrrolate is administered regularly. Consider the use of other oral dosage forms of digoxin (e.g., elixir or capsules).

Amantadine

The anticholinergic effects of glycopyrrolate may be increased with concomitant administration of amantadine. Consider decreasing the dose of glycopyrrolate during coadministration of amantadine.

Drugs Whose Plasma Levels May be Increased by Glycopyrrolate

Coadministration of glycopyrrolate may result in increased levels of certain drugs.

  • Atenolol’s bioavailability may be increased with coadministration of glycopyrrolate. A reduction in the atenolol dose may be needed.
  • Metformin plasma levels may be elevated with coadministration of glycopyrrolate, increasing metformin’s pharmacologic and toxic effects. Monitor clinical response to metformin with concomitant glycopyrrolate administration; consider a dose reduction of metformin if warranted.

Drugs Whose Plasma Levels May be Decreased by Glycopyrrolate

Coadministration of glycopyrrolate may result in decreased levels of certain drugs.

  • Haloperidol’s serum level may be decreased when coadministered with glycopyrrolate, resulting in worsening of schizophrenic symptoms, and development of tardive dyskinesia. Closely monitor patients if coadministration cannot be avoided.
  • Levodopa’s therapeutic effect may be reduced with glycopyrrolate administration. Consider increasing the dose of levodopa.

USE IN PREGNANCY

There are no available data in pregnant women for CUVPOSA to inform decisions concerning any drug-associated risks.

PEDIATRIC USE

CUVPOSA was evaluated for chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling. CUVPOSA has not been studied in subjects under the age of 3 years.

Please see full Prescribing Information.