The FDA has approved Cuvposa (glycopyrrolate liquid, from Shionogi), an orphan drug, for the treatment of chronic severe drooling associated with neurologic conditions (eg, cerebral palsy) in patients 3–16 years of age. Cuvposa competitively inhibits acetylcholine receptors located on certain peripheral tissues (eg, salivary glands) to indirectly reduce the rate of salivation. This approval is based on data from a Phase 3, randomized, double-blind, placebo-controlled study which showed that 75% of children and adolescents treated with Cuvposa experienced an improvement in symptoms, versus 11% who received placebo.
Cuvposa is expected to be available as a 1mg/5mL cherry flavored oral solution.
For more information call (973) 966-9600 or visit www.shionogi-inc.com.