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news.Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai, has announced that the FDA has approved Aciphex 20mg for the short-term treatment of gastroesophageal reflux disease in adolescents ages 12 and above.
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Included in the submission was a 12-week, multi-center, open-label, randomized, parallel-group study of 111 adolescent gastroesophageal reflux disease (GERD) patients.
In this study, Aciphex was well tolerated in adolescent subjects, with a safety profile similar to that of adults. Efficacy results demonstrated that once-daily treatment with Aciphex 20mg for eight weeks reduced the severity and frequency of GERD symptoms compared to symptoms prior to treatment.