WOODCLIFF LAKE, N.J., June 30 NJ-Eisai-FDA-Approved
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 other
GERD symptoms. The safety and effectiveness of ACIPHEX has not been
established for children under the age of 12.
Important Safety Information
ACIPHEX has a well-established safety profile. The most common side effect
possibly related to ACIPHEX is headache. Symptom relief does not rule out
other serious stomach conditions. Patients on warfarin (such as Coumadin(R))
may need to be monitored more closely by their doctor. To learn more, talk to
your doctor and see the full product information at www.aciphex.com.
About Eisai Corporation of North America
Eisai Corporation of North America is a wholly-owned subsidiary of Eisai
Co., Ltd., a research-based human health care (hhc) company that discovers,
develops and markets products throughout the world. Eisai focuses its efforts
in three therapeutic areas: neurology, gastrointestinal disorders and
oncology/critical care.
Eisai Corporation of North America supports the activities of its
operating companies in North America. These operating companies include: Eisai
Research Institute of Boston, Inc., a discovery operation with strong organic
chemistry capabilities; Morphotek, Inc., a biopharmaceutical company
specializing in the development of therapeutic monoclonal antibodies; Eisai
Medical Research Inc., a clinical development group; Eisai Inc., a commercial
operation with manufacturing and marketing/sales functions; MGI PHARMA, INC.,
an R&D and commercial operation with manufacturing and marketing/sales
functions; and Eisai Machinery U.S.A., which markets and maintains
pharmaceutical manufacturing machinery.
For more information about Eisai, please visit www.eisai.com.
ACIPHEX is a registered trademark of Eisai Co., Ltd.
Coumadin is a registered trademark of Bristol-Myers Squibb Pharma Company.
For Media Inquiries: For Investor Inquiries:
Judee Shuler Bob Laverty
Eisai Inc. Eisai Corporation of North America
(201) 746-2241 (201) 746-2265
SOURCE Eisai Corporation of North America
