FSC Laboratories acquires exclusive marketing rights for Aciphex Sprinkle in the U.S.

Jun 30 2014

FSC Therapeutics, LLC, today announced that the Company has entered into a transaction with Eisai Inc. to acquire exclusive U.S. marketing rights for AcipHex® Sprinkle™ (rabeprazole sodium), Delayed-Release Capsules, 5 mg and 10 mg, for the treatment of Gastroesophageal Reflux Disease (GERD) in children 1 to 11 years of age for up to 12 weeks. AcipHex Sprinkle will be distributed by FSC Laboratories, Inc., and promoted by its subsidiary, FSC Pediatrics, Inc., to pediatric primary care-focused practitioners across the U.S.

"The addition of AcipHex Sprinkle to our portfolio of products demonstrates our 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," said Peter W. Steelman, President and Chief Executive Officer of FSC Pediatrics.

AcipHex Sprinkle is a delayed-release capsule that can be sprinkled on a small amount of soft food (e.g., applesauce, fruit or vegetable based baby food, or yogurt) or the capsule granules can be emptied into a small amount of liquid (e.g., infant formula, apple juice, or pediatric electrolyte solution).

The approval of AcipHex Sprinkle is supported by the largest clinical study conducted in pediatric patients 1 to 11 years of age for the treatment of GERD. The clinical trial was a multicenter, double-blind, parallel-group study conducted in 127 pediatric patients over a 12-week treatment period and a 24-week extension period of two dose levels of rabeprazole. The AcipHex Sprinkle study enrolled children with endoscopically confirmed GERD who were reevaluated endoscopically at the conclusion of the study.

Overall, 81 percent of patients achieved healing during the 12-week treatment period and 90 percent of those patients retained healing during the ensuing 24-week extension period. The absence of a placebo group does not allow assessment of sustained efficacy through 36 weeks. There were no adverse reactions reported in this study that were not previously observed in adolescents or adults.