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:5/26/2016)... Q BioMed Inc. (OTCQB: QBIO), a ... featured presenter at the 5th Annual Marcum MicroCap Conference on ... at the Grand Hyatt Hotel. The ... CEO, is scheduled to begin at 11a.m ET in the ... recent developments and outline milestones for the balance of 2016 ...
(Date:5/26/2016)... ... 26, 2016 , ... Kinder Scientific (KinderScientific.com), a leading animal ... the Company for the future. Kinder Scientific announces restructured ownership and additional ... appointed Chairman of the Board, Curtis D. Kinghorn has been appointed CEO/President and ...
(Date:5/25/2016)... ... May 25, 2016 , ... Thailand’s Board of Investment’s New ... San Francisco. Located at booth number 7301, representatives from the Thai Government, research ... the Thai biotechnology and life sciences sector. , Deputy Secretary General of ...
(Date:5/25/2016)... ... 25, 2016 , ... The American Medical Informatics Association (AMIA) ... National Coordinator for Health IT (ONC) outlining a measurement approach to interoperability that ... when and where it was needed. The organization of health informatics professionals said ...
Breaking Biology Technology:
(Date:3/23/2016)... , March 23, 2016 ... erhöhter Sicherheit Gesichts- und Stimmerkennung mit Passwörtern ... (NASDAQ: MESG ), ein führender ... das Unternehmen mit SpeechPro zusammenarbeitet, um erstmals ... Finanzdienstleistungsbranche, wird die Möglichkeit angeboten, im Rahmen ...
(Date:3/18/2016)... --> --> Competitive Landscape Analysis ... Physical infrastructure and Perimeter Surveillance & Detection Systems ... and the continuing migration crisis in the Middle ... led visiongain to publish this unique report, which is crucial ... & security companies in the border security market and the ...
(Date:3/14/2016)... 14, 2016 NXTD ) ("NXT-ID" or ... market, announces the airing of a new series of commercials ... of March 21 st .  The commercials will air on ... Squawk on the Street show. --> NXTD ) ... mobile commerce market, announces the airing of a new series ...
Breaking Biology News(10 mins):