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Study Data Show CUVPOSA® Reduced Chronic Severe Drooling in Patients Ages 3-16 Years-Old with Neurologic Conditions
Date:1/25/2012

FLORHAM PARK, N.J., Jan. 25, 2012 /PRNewswire/ -- Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., today announced results from two studies published online today in the journal Therapeutics and Clinical Risk Management: the first study, a randomized, double-blind, placebo-controlled phase III trial, showed that children ages 3-16 with problem drooling due to neurologic conditions demonstrated a significantly better response to CUVPOSA® (glycopyrrolate) oral solution than to placebo.(1) The second study, a multicenter, open-label trial, evaluated the safety and efficacy of CUVPOSA® for over 24 weeks.(2)  The majority of patients in this study were between the ages of 3-16 with moderate-to-severe drooling.  CUVPOSA® oral solution is the first and only U.S. Food and Drug Administration-approved treatment to reduce chronic severe drooling in patients ages 3-16 with neurologic conditions associated with problem drooling, such as cerebral palsy.  

"Chronic severe drooling is a health issue for children with neurologic disorders," said lead study investigator Robert S. Zeller, MD, director, Blue Bird Circle Clinic for Pediatric Neurology at Texas Children's Hospital, Houston, Texas. "These studies reinforce the efficacy and safety, respectively, of CUVPOSA®." 

After eight weeks in the first study of 38 patients [CUVPOSA® (n=20), placebo (n=18)], 14 of 19 patients (73.7 percent) in the CUVPOSA® group and three of 17 (17.6 percent) in the placebo group exhibited at least a 3-point improvement on the modified Teacher's Drooling Scale (mTDS) (P=0.0011).  Two of the 38 patients were older than 16 and, as such, were excluded from the results.  A beneficial effect of CUVPOSA® was observed as early as two weeks after treatment initiation (52.6 percent; P=0.0007), with the proportion of responders increasing continuously through week 8.  M
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SOURCE Shionogi Inc.
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