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.
ACIPHEX was discovered and developed by Eisai and is copromoted in the United States with PriCara(R), a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
About ACIPHEX(R) (rabeprazole sodium)
ACIPHEX(R) is a prescription medication. ACIPHEX 20 mg tablet once daily is approved for use in adults:
-- for the short-term (4 to 8 weeks) treatment in the healing and symptom relief of damaging (erosive) Gastroesophageal Reflux Disease (GERD).
-- to maintain healing of damage (erosions) and relief of heartburn symptoms with GERD. ACIPHEX has not been studied for treatment lasting longer than 12 months (1 year).
-- for the treatment of day-time and night-time heartburn and other symptoms that happen with GERD.
ACIPHEX 20 mg once daily is now also indicated for adolescents ages 12
and above for the short-term treatment (up to 8 weeks) for heartburn and
|SOURCE Eisai Corporation of North America|
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