CHARLOTTE, N.C.--(BUSINESS WIRE)--FSC Therapeutics, LLC, today announced that the Company has entered into a transaction with Eisai Inc. to acquire exclusive U.S. marketing rights for AcipHex® Sprinkle™ (rabeprazole sodium), Delayed-Release Capsules, 5 mg and 10 mg, for the treatment of Gastroesophageal Reflux Disease (GERD) in children 1 to 11 years of age for up to 12 weeks. AcipHex Sprinkle will be distributed by FSC Laboratories, Inc., and promoted by its subsidiary, FSC Pediatrics, Inc., to pediatric primary care-focused practitioners across the U.S.
“The addition of AcipHex Sprinkle to our portfolio of products demonstrates our commitment to improving the health of pediatric patients. We are pleased to offer a treatment option for the many young children who suffer from GERD,” said Peter W. Steelman, President and Chief Executive Officer of FSC Pediatrics.
AcipHex Sprinkle is a delayed-release capsule that can be sprinkled on a small amount of soft food (e.g., applesauce, fruit or vegetable based baby food, or yogurt) or the capsule granules can be emptied into a small amount of liquid (e.g., infant formula, apple juice, or pediatric electrolyte solution).
The approval of AcipHex Sprinkle is supported by the largest clinical study conducted in pediatric patients 1 to 11 years of age for the treatment of GERD. The clinical trial was a multicenter, double-blind, parallel-group study conducted in 127 pediatric patients over a 12-week treatment period and a 24-week extension period of two dose levels of rabeprazole. The AcipHex Sprinkle study enrolled children with endoscopically confirmed GERD who were reevaluated endoscopically at the conclusion of the study.
Overall, 81 percent of patients achieved healing during the 12-week treatment period and 90 percent of those patients 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. There were no adverse reactions reported in this study that were not previously observed in adolescents or adults.
About AcipHex® Sprinkle™
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.
For more information about AcipHex Sprinkle (rabeprazole sodium), click here for the full Prescribing Information or visit www.aciphex.com.
ACIPHEX® Sprinkle™ is a trademark of Eisai R&D Management Co., Ltd.
About FSC Pediatrics
FSC Pediatrics, Inc., a subsidiary of FSC Laboratories, based in Charlotte, NC, is a specialty pharmaceutical and medical device company founded in 2004, solely dedicated to providing innovative solutions to unmet medical needs for pediatric patients. FSC Pediatrics provides products that meet pediatric primary care and specialist needs in the following therapeutic categories: Infection, Central Nervous System (CNS), and Allergy/Asthma. More information is available at www.fscpediatrics.com.