FDA Approves ACIPHEX® Sprinkle™ (Rabeprazole Sodium) For Use in Children Ages
1 to 11
WOODCLIFF LAKE, N.J., March 26, 2013
WOODCLIFF LAKE, N.J., March 26, 2013 /PRNewswire/ --Eisai Inc. announced
today that the U.S. Food and Drug Administration (FDA) has approved ACIPHEX^®
Sprinkle™ Delayed-Release Capsules 5mg and 10mg for the treatment of
Gastroesophageal Reflux Disease (GERD) in children 1 to 11 years of age for up
to 12 weeks.
"We are proud to offer a new treatment option for young children who suffer
from GERD," said Lonnel Coats, president and CEO of Eisai Inc. "Eisai is
committed to keeping the medical needs of patients and their families at the
forefront of all that we do, as part of our human health care (hhc) corporate
The approval of ACIPHEX Sprinkle is based on the results of a clinical trial
of pediatric patients 1 to 11 years of age. The clinical trial was a
multicenter, double-blind, parallel-group study conducted in 127 pediatric
patients with endoscopically-proven GERD that consisted of a 12-week treatment
and a 24-week extension period of two dose levels of rabeprazole. Overall, 81
percent of patients achieved healing during the 12-week treatment period and
90 percent retained healing during the ensuing 24-week extension period. The
absence of a placebo group does not allow assessment of sustained efficacy
through 36 weeks.
In the 12-week treatment period, the most commonly reported treatment-emergent
adverse events (greater than or equal to 5% of subjects) were cough (14%),
vomiting (14%), abdominal pain (12%), diarrhea (11%), pyrexia (10%), headache
(9%), upper respiratory tract infection (8%), oropharyngeal pain (6%), and
In the 24-week extension period, the most commonly reported treatment emergent
adverse events (greater than or equal to 5% of subjects) were upper
respiratory tract infection (13%), vomiting (11%), abdominal pain (8%),
diarrhea (6%), pyrexia (5%), nasopharyngitis (5%), pharyngitis streptococcal
(5%), and sinusitis (5%).
Indication for ACIPHEX Sprinkle
ACIPHEX Sprinkle is indicated for the treatment of GERD in children 1 to 11
years of age for up to 12 weeks.
Important Safety Information about ACIPHEX Sprinkle:
oSymptom relief does not rule out other serious stomach conditions.
oSerious allergic reactions may occur. Tell your doctor if you have a rash,
face swelling, throat tightness, or difficulty breathing.
oProton Pump Inhibitor (PPI) medicines may increase your risk of getting
severe diarrhea. This diarrhea may be caused by an infection (Clostridium
difficile) in your intestines. If you have watery stool, stomach pain, and
fever that does not go away, call your doctor immediately.
oPeople who are taking multiple daily doses of PPI medicines for a long
period of time may have an increased risk of fractures of the hip, wrist,
oLow 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.
oIn children 1-11 years of age, the most common side effects with ACIPHEX
include abdominal pain, diarrhea and headache.
oBefore taking ACIPHEX, tell your doctor if you are taking any of these
medicines: atazanavir, digoxin, iron salts, ketoconazole, warfarin, or
For more information about ACIPHEX Sprinkle (rabeprazole sodium), see full
Prescribing Information or go to www.ACIPHEX.com.
About Gastroesophageal Reflux Disease (GERD)
Gastroesophageal reflux disease (GERD) is a chronic digestive disease that
occurs when stomach acid or, occasionally, bile flows back (refluxes) into
your food pipe (esophagus). The backwash of acid irritates the lining of your
esophagus and causes GERD signs and symptoms.
Signs and symptoms of GERD include acid reflux and heartburn. Both are common
digestive conditions that many people experience from time to time. When these
signs and symptoms occur at least twice each week or interfere with your daily
life, doctors call this GERD.
About Eisai Inc.
Eisai Inc. was established in 1995 and began marketing its first product in
the United States in 1997. Since that time, Eisai Inc. has rapidly grown to
become a fully integrated pharmaceutical business. Eisai's key areas of
commercial focus are neurology and oncology. 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
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.
Media Inquiries Investor Inquiries
Marcia J. Diljak Alex Scott
Eisai Inc. Eisai Inc.
SOURCE Eisai Inc.
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