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Jeff Brody
Litigators Inc.
The U.S. Food and Drug Administration has granted orphan drug designation to a new medication that is designed to treat moderate to severe chronic drooling in pediatric patients.
Chronic drooling is often seen in children with cerebral palsy and other neurological disorders.
The drug manufacturer, First Horizon Pharmaceutical Corporation, is currently conducting research and clinical trials for glycopyrrolate to ensure the safety and efficacy of the drug treatment.
“We plan to work diligently to complete our clinical trials for this much needed therapeutic treatment option for children who suffer from chronic moderate to severe drooling caused by cerebral palsy and certain other neurological disorders,” said Larry M. Dillaha, M.D., Executive Vice President and Chief Medical Officer of First Horizon.
The FDA orphan drug designation program is designed to provide an incentive to encourage drug makers to develop new treatments for diseases that affect less than 200,000 people in the U.S. Under the Orphan Drug Act, new drugs are offered tax cuts for clinical trial expenses, FDA assistance in research design, and immunity from FDA user fee.
Does your child suffer from severe drooling due to cerebral palsy? Contact a cerebral palsy attorney and find out if your child is entitled to compensation to help pay for therapy.