gesunheitpfleges.org



Zacharon, Pfizer enter research collaboration to develop drugs for orphan diseases

March 18, 2016

"Chronic severe drooling is an often overlooked condition affecting 10 to 30 percent of pediatric patients suffering from neurologic disorders," explained Dr. Robert Zeller, Director, Blue Bird Circle Clinic for Pediatric Neurology at Texas Children's Hospital and Professor, Baylor College of Medicine.  "For these children and adolescents who exhibit excessive drooling, the availability of CUVPOSA?? offers an important advancement in therapy."

CUVPOSA?? has been classified by the FDA as an "Orphan Drug" that was developed to treat a rare disease or condition (chronic severe drooling). Clinical studies of orphan drugs do not typically contain high numbers of study subjects. The FDA approval of CUVPOSA?? in July 2010 was based on the results of a 8-week randomized, double-blind, placebo-controlled Phase III study of 38 subjects which showed that 75% of children and adolescents treated with CUVPOSA?? experienced an improvement in symptoms, versus 11% who received placebo. CUVPOSA?? was also evaluated in a long-term, open-label, 24-week safety study in 137 patient subjects. Dry mouth, vomiting, constipation, flushing and nasal congestion were the most commonly reported adverse reactions.

SOURCE Shionogi Inc.