FDA approves Eisai's Aciphex Sprinkle for GERD in children; Inovelon OKed in Japan

Japanese drug major Eisai (TYO: 4523) says that the US Food and Drug Administration has approved Aciphex Sprinkle (rabeprazole sodium) delayed-release capsules for the treatment of gastroesophageal reflux disease (GERD) in children aged one to 11 years of age for up to 12 weeks.

The approval of Aciphex Sprinkle is based on the results of a clinical trial of pediatric patients one to 11 years of age. The clinical trial was a multicenter, double-blind, parallel-group study conducted in 127 pediatric patients with endoscopically-proven GERD that consisted of a 12-week treatment and a 24-week extension period of two dose levels of rabeprazole. Overall, 81% of patients achieved healing during the 12-week treatment period and 90% 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.

In the 12-week treatment period, the most commonly reported treatment-emergent adverse events (greater than or equal to 5% of subjects) were cough (14%), vomiting (14%), abdominal pain (12%), diarrhea (11%), pyrexia (10%), headache (9%), upper respiratory tract infection (8%), oropharyngeal pain (6%), and nasopharyngitis (5%).