Drooling
is normal in infants. But 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.
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. A
drug is said to be used off-label when a physician prescribes its use in
a different way than described in the FDA-approved drug label.
In
2001, the FDA held an advisory committee meeting to discuss how best to
develop products for drooling with ethically and scientifically sound
trials in children who have neurological disorders. Utilizing the advice
provided, the FDA has been able to move forward in addressing the needs
of this population.
“Cuvposa provides an important therapy for
controlling salivation in patients with neurologic disease,” said John
Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center
for Drug Evaluation and Research. “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.”
The FDA drug approval process provides a
review of product-specific information that is critical to ensuring the
safety and efficacy of a finished drug product. For instance, the
applicant must demonstrate that its manufacturing processes can reliably
produce drug products of expected identity, strength, quality, and
purity.
FDA's review of the applicant's labeling ensures that health
care professionals and patients have the information necessary to
understand a drug product's risks and its safe and effective use.
When
used off label, oral tablets of glycopyrrolate had to be crushed to
treat drooling in children with neurological disorders. 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 (placebo).
Common adverse
reactions reported with glycopyrrolate are dry mouth, constipation,
flushing, and urinary retention.
Cuvposa (glycopyrrolate) Oral
Solution is marketed by Shionogi Pharma Inc. of Osaka, Japan.
Source: U.S.Food and Drug Administration
