Source: DGNews  |  Posted 3 years ago

WOODCLIFF LAKE, NJ -- July 1, 2008 -- The US Food and Drug Administration (FDA) has approved rabeprazole sodium (Aciphex) for the short-term (up to 8 weeks) treatment of gastro-oesophageal reflux disease (GERD) in adolescents aged 12 years and older.

Rabeprazole is classified as a proton pump inhibitor that effectively suppresses gastric acid secretion while inhibiting enzyme activity during the last phase of stomach acid secretion.

The approval was based on a 12-week, multicentre, open-label, randomised, parallel-group study of 111 adolescents with GERD. In this study, rabeprazole was well tolerated in adolescent subjects, with a safety profile similar to that in adults. The adverse events reported without regard to relationship to rabeprazole that occurred in >2% of 111 patients included headache (9.9%), diarrhoea (4.5%), nausea (4.5%), vomiting (3.6%), and abdominal pain (3.6%).

Efficacy results demonstrated that once-daily treatment with rabeprazole 20 mg for 8 weeks reduced the severity and frequency of GERD symptoms compared with symptoms prior to treatment.

SOURCE: Eisai Co., Ltd.