New Drug Approvals

28 MAR 2013


The US FDA has cleared Eisai’s ACIPHEX Sprinkle (rabeprazole sodium) as 12-week gastroesophageal reflux disease (GERD) therapy for use in children between one to eleven years age.

The approval was based on positive data from multicenter, double-blind trial conducted in 127 pediatric patients between one to 11 years of age with GERD.

Eisai president and CEO Lonnel Coats said, “We are proud to offer a new treatment option for young children who suffer from GERD.”

The parallel-group study comprised a treatment period of 12 weeks and an extension period of two dose levels of rabeprazole for 24 weeks.

Healing was achieved in 81% of patients during the treatment period and 90% retained healing during the extension period.

The active ingredient in ACIPHEX Delayed-Release Tablets is rabeprazole sodium, a substituted benzimidazole that inhibits gastric acid secretion. Rabeprazole sodium is known chemically as 2-[[[4-(3methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1H–benzimidazole sodium salt. It has…

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