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news.US-based FSC Therapeutics has entered into an agreement with Eisai to acquire exclusive US marketing rights for AcipHex Sprinkle (rabeprazole sodium), Delayed-Release Capsules, 5mg and 10mg, to treat Gastroesophageal Reflux Disease (GERD) in children 1 to 11 years of age for up to 12 weeks.
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Under the deal, AcipHex Sprinkle will be distributed by FSC Laboratories and promoted by its subsidiary, FSC Pediatrics, to pediatric primary care-focused practitioners across the US.
FSC Pediatrics president and chief executive officer Peter Steelman said the addition of AcipHex Sprinkle to the company’s portfolio of products shows its commitment to improving the health of pediatric patients.
"We are pleased to offer a treatment option for the many young children who suffer from GERD," Steelman said.
The delayed-release capsule can be sprinkled on a small amount of soft food or the capsule granules can be emptied into a small amount of liquid.
The approval of AcipHex Sprinkle is supported by the largest clinical trial carried out in pediatric patients one to 11 years of age for the treatment of GERD.
The multicenter, double-blind, parallel-group trial enrolled about 127 pediatric patients over a 12-week treatment period and a 24-week extension period of two dose levels of rabeprazole.
The trial enrolled children with endoscopically confirmed GERD who were reevaluated endoscopically at the conclusion of the trial.