US Food and Drug Administration (FDA) has approved Aciphex (rabeprazole sodium) 20 mg for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in adolescents ages 12 and above for Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd.

Aciphex was discovered and developed by Eisai and is co-promoted in the United States with PriCara, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Included in the submission was a 12-week, multi-centre, open-label, randomized, parallel-group study of 111 adolescent GERD patients.

In this study, Aciphex was well tolerated in adolescent subjects, with a safety profile similar to that of adults. The adverse events reported without regard to relationship to Aciphex that occurred in >2 percent of 111 patients were headache (9.9 percent), diarrhoea (4.5 percent), nausea (4.5 percent), vomiting (3.6 per cent) and abdominal pain (3.6 percent). Efficacy results demonstrated that once-daily treatment with Aciphex 20 mg for eight weeks reduced the severity and frequency of GERD symptoms compared to symptoms prior to treatment.