Eisai Inc. Discontinues Global Development of Rabeprazole Sodium Extended-Release Capsules, 50 mg
Published: Sep 06, 2011
On February 1, 2011, Eisai received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application of rabeprazole sodium extended-release capsules, 50 mg. (U.S. brand name: Aciphex®). After full consideration of the discussion with the FDA regarding the CRL, it was determined that an additional study would be required to support approval. Upon further review, Eisai has decided to discontinue the global development of the product.
Eisai remains committed to continue marketing Aciphex® (rabeprazole sodium) delayed-release tablet. Aciphex is a proton pump inhibitor (PPI) discovered and developed by Eisai. Launched first in Japan in 1997, followed by Europe in 1998, and the United States in 1999, it is currently approved in more than 90 countries around the world as a treatment of various acid-related gastrointestinal diseases. In the U.S., where the product is co-promoted with Janssen Pharmaceuticals, Inc., the indications for Aciphex in adults include: healing of erosive or ulcerative gastroesophageal reflux disease (GERD), maintenance of healing of erosive or ulcerative GERD, treatment of symptomatic GERD, and healing of duodenal ulcers, Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence, treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Aciphex is also indicated in adolescents 12 years of age and above for the short-term treatment of symptomatic GERD. Additionally, Eisai is conducting a pediatric clinical program for Aciphex with Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Important Safety Information for Aciphex® (rabeprazole sodium) delayed-release tablet
- Symptom relief does not rule out other serious stomach conditions.
- Serious allergic reactions may occur. Tell your doctor if you have a rash, face swelling, throat tightness, or difficult breathing.
- People who are taking multiple daily doses of Proton Pump Inhibitor (PPI) medicines for a long period of time may have an increased risk of fractures of the hip, wrist, or spine.
- Low magnesium can happen in some people who take a PPI medicine for at least 3 months. Tell your doctor right away if you experience any of these symptoms: seizures, dizziness, abnormal or fast heartbeat, jitteriness, jerking movements or shaking (tremors), muscle weakness spasms of the hands and feet, cramps or muscle aches, or spasm of the voice box.
- In adolescents, the most common side effects with Aciphex include headache, diarrhea, nausea, vomiting, and abdominal pain.
- In adults, the most common side effects with Aciphex include pain, sore throat, gas, infection, and constipation.
- Before taking Aciphex, tell your doctor if you are taking any of these medicines: atazanavir, digoxin, iron salts, ketoconazole, or warfarin.
- In H. pylori clinical trials using combination therapy with rabeprazole sodium plus amoxicillin and clarithromycin (RAC), no adverse events unique to this drug combination were observed. In the US multicenter study, the most frequently reported drug-related adverse events for patients who received RAC therapy for 7 days were diarrhea (8%) and taste perversion (6%).
- No clinically significant laboratory abnormalities particular to the drug combinations were observed.
- Clarithromycin is contraindicated in patients taking cisapride or pimozide; or in patients with a known hypersensitivity to clarithromycin or any macrolide antibiotic. Clarithromycin may elevate digoxin serum concentrations. Serum digoxin levels should be carefully monitored while digoxin and clarithromycin are taken concomitantly. Clarithromycin should not be used in pregnant women except in circumstances where no alternative therapy is appropriate. (See WARNINGS and Drug Interactions in Prescribing Information for clarithromycin.) Amoxicillin is contraindicated in patients who are allergic to any penicillin.
- For more information on adverse events or laboratory changes with amoxicillin or clarithromycin, refer to their respective full Prescribing Information.
- For more information about Aciphex, please see Full Product Information available at www.aciphex.com.
About Eisai Inc.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com/US.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system.
Marcia J. Diljak, 201-746-2236
Alex Scott, 201-746-2177