FDA approves AcipHex Sprinkle for young children

FDA has approved rabeprazole sodium (AcipHex Sprinkle, Eisai) Delayed-Release capsules 5 mg and 10 mg for the treatment of gastroesophageal reflux disease (GERD) in children ages 1 to 11 years of age for up to 12 weeks.

The newly approved formulation has been developed for administration to pediatric patients in granules of the drug, contained in the capsules, sprinkled onto soft foods or into milk, baby formula, or fruit juices.

“The approval of AcipHex Sprinkle in children ages 1 to 11 provides another option for the treatment of acid-related diseases in the younger population,” said Formulary advisor Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, in Webster, Texas. “Given the very few studies performed in the population and the limited drug options that can be used in the population, this approval serves as a breakthrough by adding another choice to the drug market and potentially increasing the probability of achieving more positive treatment outcomes.”

The approval is based on a multicenter, double-blind, parallel-group study conducted in 127 pediatric patients ages 1 to 11 with endoscopically proven GERD. The study consisted of a 12-week treatment and a 24-week extension period of 2 dose levels of rabeprazole approximating 0.5 mg/kg and 1.0 mg/kg. Overall, 81% of patients achieved healing during the 12-week treatment period and 90% maintained healing during the ensuing 24-week extension period. The absence of a placebo group did not allow assessment of sustained efficacy through 36 weeks. The absence of a placebo group does not allow assessment of sustained efficacy through 36 weeks. Adverse reactions that occurred in ≥5% of patients included abdominal pain (5%), diarrhea (5%), and headache (5%). The pediatric clinical data submitted with the application have met FDA’s Written Request requirements for pediatric exclusivity, with Eisai gaining 6 additional months of US market exclusivity for the drug that will now expire on November 8, 2013. 

AcipHex is classified as a proton-pump inhibitor that effectively suppresses gastric acid secretion while inhibiting enzyme activity during the last phase of stomach acid secretion. It was launched in the United States in 1999, following its respective launches in Japan in 1997 and in Europe in 1998, and is currently approved in more than 90 countries worldwide. In the United States, the drug is currently approved for the healing and maintenance of healing of erosive and ulcerative GERD in adults, treatment of symptomatic GERD, healing of duodenal ulcers, and Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence. The drug also has been indicated in the United States for adolescent patients ages 12 years or older for the short-term treatment of symptomatic GERD.