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Press release: FDA Approves Aciphex for Short-Term Treatment of GERD in Teens

by Marijke Durning, RN on July 1st, 2008

FDA Approves ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents

WOODCLIFF LAKE, N.J., June 30 /PRNewswire/ — Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., announced today that the 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.

Included in the submission was a 12-week, multi-center, 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 greater than or equal to 2 percent of 111 patients were headache (9.9 percent), diarrhea (4.5 percent), nausea (4.5 percent), vomiting (3.6 percent) 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.  

SOURCE: Eisai Corporation of North America

Image: Newscom

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POSTED IN: Children, FDA Announcements, Medications