FDA Approves Aciphex Sprinkle
FDA Approves Aciphex Sprinkle (rabeprazole sodium) For Use in Children Ages 1 to 11
Woodcliff Lake, NJ, March 26, 2013 - 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 mission.”
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 (≥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 nasopharyngitis (5%).
In the 24-week extension period, the most commonly reported treatment emergent adverse events (≥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:
- 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 difficulty breathing.
- Proton 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.
- People 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, 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 children 1-11 years of age, the most common side effects with Aciphex include abdominal pain, diarrhea and headache.
- Before taking Aciphex, tell your doctor if you are taking any of these medicines: atazanavir, digoxin, iron salts, ketoconazole, warfarin, or methotrexate.
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 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.
Source: Eisai Inc.
Posted: March 2013