Eisai's Aciphex cleared for GERD by US FDA

The US unit of Japanese drugmaker Eisai says that the Food and Drug Administration has approved Aciphex (rabeprazole sodium) 20mg for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease in adolescents aged 12 and above.

Included in the submission was a 12-week, multicenter, open-label, randomized, parallel-group study of 111 adolescent GERD patients. In this study, the agent 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 greater than or equal to 2% of 111 patients were headache (9.9%), diarrhea (4.5%), nausea (4.5%), vomiting (3.6%) and abdominal pain (3.6%). Efficacy results demonstrated that once-daily treatment with Aciphex 20mg for eight weeks reduced the severity and frequency of GERD compared to symptoms prior to treatment. The agent is co-promoted with PriCara, which is part of Johnson & Johnson.