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news.FDA has approved Shionogi's Cuvposa (glycopyrrolate) for the treatment of chronic severe drooling in pediatric patients aged 3-16 with neurologic conditions. Cuvposa was designated an Orphan Drug by the FDA.
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Shionogi said that Cuvposa is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including salivary glands.
Cuvposa indirectly reduces the rate of salivation by preventing stimulation of these receptors. Cuvposa is available as a 1mg/5ml clear, cherry flavored oral solution.
The FDA has approved Shionogi’s Cuvposa on the basis of Phase III study results. In the trial, 75% of children and adolescents treated with Cuvposa experienced an improvement in symptoms, versus 11% who received placebo.
Cuvposa Phase study was a randomised, double-blind, placebo-controlled study.
Donald Manning, chief medical officer of Shionogi, said: “The FDA approval of Cuvposa provides parents and caregivers the first liquid medication indicated to reduce chronic severe drooling. Shionogi is proud to bring to market a product that treats an all-too-often unresolved yet damaging condition.”