Eisai announced that the FDA has approved Aciphex Sprinkle (rabeprazole sodium) Delayed-Release Capsules for the treatment of gastroesophageal reflux disease (GERD) in children 1–11 years of age for up to 12 weeks. The granule contents are sprinkled on a small amount of soft food (eg, apple sauce, fruit or vegetable based baby food, or yogurt) or into a small amount of liquid (infant formula, apple juice, or pediatric electrolyte solution).
The approval of Aciphex Sprinkle is based on the results of a multicenter, double-blind, parallel-group study conducted in 127 patients with GERD (ages 1–11 years) that consisted of a 12-week treatment and a 24-week extension period of two dose levels of rabeprazole. The study concluded that 81% of patients achieved healing during the 12-week treatment, and 90% retained healing during the 24-week extension period.
Aciphex is a proton pump inhibitor that is currently indicated as part of triple therapy for H. Pylori eradication in duodenal ulcer disease, short-term treatment of erosive or ulcerative GERD, treatment of symptomatic GERD in patients >12 years, maintenance of healing and reduction in relapse rates of heartburn symptoms in erosive or ulcerative GERD, and long-term treatment of pathological hypersecretory conditions.
Aciphex is already available as 20mg delayed-release enteric-coated tablets. Aciphex Sprinkle will be available in 5mg and 10mg strengths in 30-count bottles.
For more information call (888) 274-2378 or visit www.aciphex.com.