Navigation Links
FDA Approves ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents
Date:6/30/2008

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 http://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 http://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
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. FDA Approves CONCERTA(R) (methylphenidate HCI) Extended-release Tablets for Treatment of ADHD (Attention Deficit Hyperactivity Disorder) in Adults
2. FDA Approves Quark IND for DGFi, an siRNA Therapeutic Based on Silence Therapeutics Unique Proprietary Chemistry
3. Big Win for Biodiesel: ASTM Approves New Biodiesel Blend Specifications
4. FDA Approves GlaxoSmithKlines AVODART(R) in Combination with Tamsulosin for the Treatment of Symptomatic Enlarged Prostate
5. Arpida Annual General Meeting of Shareholders Approves All Board Proposals
6. FDA Approves MIXJECT(TM), a Convenient, Easy-to-Use Drug Delivery System For Watson Pharmaceuticals TRELSTAR(R) DEPOT and TRELSTAR(R) LA
7. FDA Approves VYVANSE(TM) (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults
8. Maryland Approves Medicaid Reimbursement for ActiPatch(R)
9. Healthcare Coalition Approves Tools to Improve Patient Safety During Transitions of Care
10. Medicare Approves in Home Sleep Apnea Testing
11. 3SBio Inc. Approves Share Repurchase Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... (PRWEB) , ... February 10, ... ... REGN) today announced that it has joined the Human Vaccines Project, a ... infectious diseases and cancer. , The Human Vaccines Project brings together ...
(Date:2/10/2016)... , ... February 10, 2016 , ... ... three states, announced today the promotion of two long-standing principal investigators (PI) to ... Family Medicine, Clinical Research and Development. , Dr. Laurence Chu, a Benchmark Research ...
(Date:2/10/2016)... ... February 10, 2016 , ... PatientCrossroads ... on the secure online PatientCrossroads platform, has exceeded both its one-year and overall ... the PROMPT study, which seeks to advance understanding of the hereditary risks for ...
(Date:2/10/2016)... ... February 09, 2016 , ... Creation Technologies, leading ... the Highest Overall Customer Rating Award from Circuits Assembly , today announced its ... the USA, Canada, Mexico and China. , The EMS provider, known in the ...
Breaking Biology Technology:
(Date:2/4/2016)... , Feb. 4, 2016 The ... apparently one of the most popular hubs of ... MetaHIT and other huge studies of human microbiota, ... past few years, the microbiome space has literally ... biomedical research. This report focuses on biomedical ...
(Date:2/2/2016)... , Feb. 2, 2016  BioMEMS ... are primarily focused on medical screening and ... point-of-care parameters. Wearable devices that facilitate and ... freedom of movement are being bolstered through ... human biomedical signal acquisition coupled with wireless ...
(Date:2/2/2016)... , Feb. 2, 2016  Based on its ... & Sullivan recognizes US-based Intelligent Retinal Imaging Systems ... Sullivan Award for New Product Innovation. IRIS, a ... North America , is poised to ... growing diabetic retinopathy market. The IRIS technology presents ...
Breaking Biology News(10 mins):